Breast Cancer
Conditions
Keywords
Trastuzumab deruxtecan, Human epidermal growth factor receptor 2 Positive Breast Cancer, Brain Metastasis
Brief summary
This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic HER2-positive breast cancer whose disease has progressed on prior anti-HER2-based regimens and who received no more than 2 lines/regimens of therapy in the metastatic setting (excluding tucatinib).
Detailed description
Approximately 500 eligible participants will be enrolled into 1 of 2 cohorts (250 participants in each cohort) according to the presence or absence of BMs at baseline. Cohort 1 will include participants without BM at baseline and Cohort 2 will consist of participants with BM at baseline. After study intervention discontinuation, all participants will undergo an end-of-treatment visit (within 7 days of discontinuation) and will be followed up for safety assessments 40 (+ up to 7) days after the discontinuation of all study intervention. All participants will be followed up for survival status and duration of treatment on subsequent therapies after intervention discontinuation every 3 months (± 14 days) from the date of the safety follow-up until death, withdrawal of consent, or the end of the study, as per defined in the protocol.
Interventions
DRUGTrastuzumab Deruxtecan
Participants will receive T-DXd administered using an IV bag containing 5% (w/v) dextrose injection infusion solution.
Sponsors
AstraZeneca
Daiichi Sankyo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
Inclusion: * Participants should have pathologically documented breast cancer that is: unresectable/advanced or metastatic; confirmed HER2-positive status expression as determined according to American Society of Clinical Oncology/College of American Pathologists guidelines * Participant must have either: no evidence of BM, or untreated BM on screening contrast brain magnetic resonance imaging/ computed tomography (MRI/CT) scan, not needing immediate local therapy or previously-treated stable or progressing BM * Participants with BMs must be neurologically stable * For participants requiring radiotherapy due to BMs, there should be an adequate washout period before day of first dosing: * ≥ 7 days since stereotactic radiosurgery or gamma knife * ≥ 21 days since whole brain radiotherapy * Eastern Cooperative Oncology Group performance status 0-1 * Previous breast cancer treatment: radiologic or objective evidence of disease progression on or after HER2 targeted therapies and no more than 2 lines/regimens of therapy in the metastatic setting * Participant with the following measurable: at least 1 lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter with CT or MRI and is suitable for accurate repeated measurements; or following Non-measurable diseases: Non-measurable, bone-only disease that can be assessed by CT or MRI or X-Ray. Lytic or mixed lytic bone lesions that can be assessed by CT or MRI or X-ray in the absence of measurable disease as defined above is acceptable; Participants with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible; and Non-measurable CNS disease (Cohort 2 only) * Adequate organ and bone marrow function within 14 days before the day of first dosing as defined in the protocol * Left ventricular ejection fraction ≥ 50% within 28 days before enrollment * Negative pregnancy test (serum) for women of childbearing potential
Exclusion criteria
* Known or suspected leptomeningeal disease * Prior exposure to tucatinib treatment * Refractory nausea and vomiting, chronic gastrointestinal disease, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of T-DXd * History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence * Based on screening contrast brain MRI/CT scan, participants must not have any of the following: any untreated brain lesions \> 2.0 cm in size; ongoing use of systemic corticosteroids for control of symptoms of BMs; any brain lesion thought to require immediate local therapy; have poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to BMs not withstanding CNS-directed therapy * Has spinal cord compression * Known active hepatitis B or C infection, such as those with serologic evidence of viral infection within 28 days of Cycle 1 Day 1. Participants with past or resolved hepatitis B virus infection are eligible, if negative for hepatitis B surface antigen and positive for anti-hepatitis B core antigen * Participants positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA * Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals * Receipt of live, attenuated vaccine within 30 days prior to the first dose of T-DXd * Participants with a medical history of myocardial infarction within 6 months before screening, symptomatic congestive heart failure (New York Heart Association Class II to IV) * History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening * Lung-specific intercurrent clinically significant illnesses and any autoimmune, connective tissue or inflammatory disorders * Prior exposure, without adequate treatment washout period before the day of first dosing, to chloroquine/hydroxychloroquine: \< 14 days * Anticancer chemotherapy: immunotherapy (non-antibody-based therapy), retinoid therapy, hormonal therapy: \< 3 weeks * \< 6 weeks for nitrosoureas or mitomycin * Antibody-based anticancer therapy: \< 4 weeks * Any concurrent anticancer treatment. Concurrent use of hormonal therapy for noncancer- related conditions is allowed * Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline * Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation, radiation to the chest, or to more than 30% of the bone marrow within 4 weeks before the first dose of study intervention * Participants with prior exposure to immunosuppressive medication within 14 days prior to first study dose * Participants with a known hypersensitivity to study intervention or any of the excipients of the product or other monoclonal antibodies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) in Cohort 1 (Participants Without Brain Metastasis at Baseline) | From first dose (Day 1) to progression of disease (up to 2 years 7 months) | The ORR is defined as the percentage (%) of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as determined by independent central review (ICR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. |
| Progression-free Survival (PFS) Rate at 12 Months in Cohort 2 (Participants With Brain Metastasis at Baseline) | At 12 months | The PFS rate is the percentage of participants alive and free of disease progression at 12 months, estimated by the Kaplan-Meier method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival Rate at 12 Months | At 12 Months | Survival rate is the percentage of participants alive at 12 months, estimated by the Kaplan-Meier method. |
| Objective Response Rate in Cohort 2 (Participants With Brain Metastasis at Baseline) | From first dose (Day 1) to progression of disease (up to 2 years 7 months) | The ORR is defined as the percentage of participants who have a confirmed CR or confirmed PR, as determined by ICR per RECIST 1.1. |
| Duration of Response (DoR) | From the date of first documented confirmed response until date of documented progression (up to 2 years 7 months) | Duration of response is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 as assessed by ICR or death due to any cause. |
| Time to Progression | From first dose (Day 1) to progression of disease (up to 2 years 7 months) | Time to progression by RECIST 1.1 per ICR is defined as the time from the date of the first dose of study intervention to the date of documented disease progression. |
| Duration of Treatment on Subsequent Lines of Therapy | From the date of first dose of a subsequent therapy until date of last dose of therapy (up to 2 years 7 months) | Duration of treatment on subsequent therapy is defined as the time from the date of first dose of a subsequent therapy until date of the last dose of that therapy. |
| Second Progression-Free Survival Rate at 12 Months | At 12 Months | Second progression-free survival rate is the percentage of participants alive and free from a second progression on next-line treatment at 12 months, estimated by the Kaplan-Meier method. The second progression is defined as the earliest progression event subsequent to the first anti-cancer therapy after the initial progression. |
| Incidence of New Symptomatic Central Nervous System (CNS) Metastasis During Treatment Without CNS Metastasis at Baseline (Cohort 1) | From first dose (Day 1) to end of treatment (up to 2 years 7 months) | The incidence rate is defined as proportion of participants with new symptomatic CNS metastases during treatment period in participants without symptomatic CNS metastasis at baseline. |
| Time to Next Progression (CNS or Extracranial) or Death | From date of first documented isolated CNS progression to the date of the next documented disease progression (up to 2 years 7 months) | The time to next progression is defined as the time from the date of the first documented isolated CNS progression to the date of the next documented disease progression (CNS or extracranial) per RECIST 1.1 or death and has been summarized descriptively in participants who have developed isolated CNS progression, receive local therapy, and continue on protocol therapy. |
| Site (CNS vs Extracranial vs Both) of Next Progression | From the date of the first documented isolated CNS progression to the date of the next documented CNS disease progression (up to 2 years 7 months) | Site of next progression (CNS \[CNS RECIST 1.1\] or extracranial \[systemic RECIST 1.1\] in participants who developed isolated CNS progression, received local therapy, and continued on protocol therapy. |
| Central Nervous System Progression-free Survival Rate at 12 Months in Participants With Brain Metastasis at Baseline (Cohort 2) | At 12 Months | Central nervous system progression free survival rate is the percentage of participants free from central nervous system progression at 12 months, estimated by the Kaplan-Meier method. |
| Time to New CNS Lesions in Participants With Brain Metastasis at Baseline (Cohort 2) | From first dose (Day 1) to the date of documented new CNS lesions (up to 2 years 7 months) | The time to new CNS lesions is defined as the time from the date of the first dose of study intervention to the date of documented new CNS lesions by RECIST 1.1 per ICR. |
| Central Nervous System Objective Response Rate in Participants With Brain Metastasis at Baseline by ICR (Cohort 2) | From first dose (Day 1) until CNS progression of disease (up to 2 years 7 months) | The CNS ORR is defined as the percentage of participants with measurable brain metastasis at baseline who have a confirmed CR or confirmed PR of brain lesions, as determined by ICR per CNS RECIST 1.1. |
| Central Nervous System Duration of Response in Participants With Brain Metastasis at Baseline (Cohort 2) | From date of first documented confirmed CNS response until CNS progression of disease (up to 2 years 7 months) | The CNS DoR is defined as the time from the date of first documented confirmed CNS response until date of documented CNS progression per CNS RECIST 1.1 as assessed by ICR or death due to any cause. |
| Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Time from first dose up to 47 days after last dose, or prior to starting any subsequent therapy, or for up to 2 years 7 months, whichever occurred first | The EORTC QLQ-C30 is a 30-item questionnaire for cancer assessment. Increased scores indicate improvement; decreased scores indicate deterioration. Physical function: ≥+9= improvement, ≤-10=deterioration, otherwise=no change; Role functioning: ≤-6=deterioration, otherwise=no change; Social functioning: ≥+8=improvement, ≤-7=deterioration, otherwise=no change; Cognitive functioning: ≥+ 5=improvement, ≤- 4=deterioration, otherwise=no change; Global Health Status: ≥+2=improvement, ≤-8=deterioration, otherwise=no change; Fatigue: ≥+8=improvement, ≤-8=deterioration, otherwise=no change; Nausea and vomiting: ≤-11=deterioration, otherwise=no change; Appetite loss: ≤-14=deterioration, otherwise=no change; rest of scales: ≥+10=improvement, ≤-10=deterioration, otherwise=no change. Best on treatment response is best response category (improvement, no change, and deterioration) achieved by participants between first dose and 47 days after last dose, and prior to starting any anticancer therapy. |
| Number of Participants With Neurologic Assessment in Neuro-Oncology Scale (NANO Scale) | Time from first dose up to 47 days after last dose, or prior to starting any subsequent therapy, or for up to 2 years 7 months, whichever occurred first | The NANO scale is a clinician-reported assessment of neurologic functioning in neuro-oncology participants. The instrument captures 9 domains (gait, strength, ataxia, sensation, visual fields, facial strength, language, level of consciousness, and behavior) and was developed to provide a simple, objective assessment of neurologic function that would be combined with radiographic assessment to provide an overall outcome assessment for neuro-oncology participants in clinical trials and in daily practice. The soring scale for Gait consists of score range 0-3, Strength consists of score range 0-2, ataxia (upper extremity) consists of scale range 0-2 and sensation as 0. Higher scores indicate worse neurologic function. The response categories reported are changes from first post-baseline score to worst on-treatment score at any point of treatment. |
| Cognitive Functions Tests: Paired Associates Learning (PAL) First Attempt Memory Score (PALFAMS) | Baseline, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, and Cycle 17 Day 1 (21 days cycle) | The PAL is a computerized, self-completed cognitive test used to capture cognitive function, including attention, memory, and executive function. This gamified test included PAL and was a low-burden, highly sensitive, precise measure of cognitive function. The PALFAMS is the number of times a participant chose the correct box on their first attempt when recalling the pattern locations, calculated across all assessed trials. A higher number of events of selecting correct boxes indicates better cognitive function. Here, baseline was the last non-missing value prior to administration of the first dose of study intervention. |
| Cognitive Functions Tests: Paired Associates Learning Total Errors Adjusted (PALTEA) | Baseline, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, and Cycle 17 Day 1 (21 days cycle) | The PAL is a computerized, self-completed cognitive test used to capture cognitive function, including attention, memory, and executive function. This gamified test included PALTEA and was a low-burden, highly sensitive, precise measure of cognitive function. PALTEA is the number of times a participant chose the incorrect box for a stimulus on assessment problems, plus an adjustment for the estimated number of errors they would have made on any problems, attempts, and recalls they did not reach. A higher number of events of selecting incorrect boxes indicates worse cognitive function. Here, baseline was the last non-missing value prior to administration of the first dose of study intervention. |
| Cognitive Functions Tests: Reaction Time (RTI) | Baseline, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, and Cycle 17 Day 1 (21 days cycle) | This is a computerized, self-completed cognitive test used to capture cognitive function, including attention, memory, and executive function. This gamified test included Reaction Time Task (RTI) and was low-burden, highly sensitive, precise measures of cognitive function. RTI Median Five-Choice Movement Time: median time taken for a participant to release response button and select target stimulus after it flashed yellow on screen. Calculated across correct, assessed trials in which stimulus could appear in any one of five locations. RTI Median Five-Choice Reaction Time: median duration it took for a participant to release response button after presentation of target stimulus. Calculated across correct, assessed trials in which stimulus could appear in any one of five locations. Measured in milliseconds. Higher reaction times indicate worse cognitive function. Here, baseline was the last non-missing value prior to administration of the first dose of study intervention. |
| Cognitive Functions Tests: Spatial Working Memory (SWM) | Baseline, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, and Cycle 17 Day 1 (21 days cycle) | The SWM is a computerized cognitive test. The SWM Between Errors (SWMBE) is number of times a participant incorrectly revisits a box in which a token has previously been found, calculated across all 4, 6, and 8 token trials. SWM Between Errors 4 Boxes (SWMBE4), SWM Between Errors 6 Boxes (SWMBE6), and SWM Between Errors 8 Boxes (SWMBE8) are number of times a participant revisits a box in which a token has previously been found. These are calculated across all trials with 4 tokens only for SWMBE4, 6 tokens only for SWMBE6, and 8 tokens only for SWMBE8. SWM Total Errors is number of times a box is selected that is certain not to contain a token and therefore should not have been visited by participant. A higher number of incorrect revisit events to previously found token boxes indicates worse cognitive function, and a lower number of revisit events indicates better cognitive function. Here, baseline was last non-missing value prior to administration of first dose of study intervention. |
| Cognitive Functions Tests: Spatial Working Memory Strategy (SWMS) | Baseline, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, and Cycle 17 Day 1 (21 days cycle) | The SWM is a computerized cognitive test. The SWMS, the number of times a participant restarted search patterns from the same initial box, indicating their use of a planned strategy to find tokens. An increased number of events where search patterns started from the same initial box suggested participants were using a planned strategy to find tokens, which indicated better cognitive function. Here, a low score indicated high strategy use (1 = they always began the search from the same box). Conversely, high scores represented a decrease in events of beginning searches from the same box. Instead, starting from many different boxes suggested the participant was not using a consistent strategy, which indicated worse cognitive function. This was calculated across assessed trials with 6 tokens or more. Here, baseline was the last non-missing value prior to administration of the first dose of study intervention. |
| St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | From time of ILD/pneumonitis diagnosis (every week) until end of safety follow-up (47 days post last dose) (up to 2 years 7 months) | The effect of T-DXd on symptoms, functioning, and HRQoL in HER2+ MBC participants with or without baseline brain metastasis was evaluated. The SGRQ-I is an idiopathic pulmonary fibrosis-specific version of the instrument developed and validated for use among participants with idiopathic pulmonary fibrosis, a type of ILD. The SGRQ-I was used to assess the HRQoL among participants who have been diagnosed with ILD/pneumonitis. It includes 34 of the original SGRQ items determined to be most reliable for assessing the HRQoL of participants with idiopathic pulmonary fibrosis. The instrument yields 3 domain scores (symptoms, activity, and impact) as well as a total score, with scores ranging from 0 to 100. Higher scores indicate greater impairment in HRQoL. |
| MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, and Cycle 39 Day 1 (21 days cycle) | The T-DXd on symptoms, functioning, and HRQoL in HER2+ MBC participants with or without baseline brain metastasis was evaluated. The MDASI brain tumor module includes 9 symptoms specific to brain tumors (weakness on one side of the body, difficulty understanding, difficulty speaking, seizures, difficulty concentrating, problems with vision, change in appearance, change in bowel pattern (diarrhea or constipation), and irritability). These 9 items will be used to capture symptoms associated with brain metastasis for those diagnosed with brain metastasis. Each item is rated on an 11-point numeric rating scale on a scale of 0-10, with higher scores indicating greater symptom severity. Here, baseline was the last non-missing value prior to administration of the first dose of study intervention. |
| Number of Participants With Adverse Events (AEs) | From first dose until end of safety follow-up (47 days post last dose) (up to 2 years 7 months) | The safety and tolerability of the participants who received T-DXd was evaluated. SAE=Serious adverse events; CTCAE=Common Terminology for Adverse Events |
| Number of Participants With Investigator-assessed ILD/Pneumonitis | From first dose until end of safety follow-up (47 days post last dose) (up to 2 years 7 months) | The number of participants with ILD/Pneumonitis were by grouped term based on Investigator-reported preferred terms. No adjudication was performed. |
| Number of Participants With ILD Clinical Symptoms Resolution Among ILD/Pneumonitis Participants Who Have Been Treated With High Dose Steroid | From first dose until end of safety follow-up (47 days post last dose) (up to 2 years 7 months) | The number of participants with ILD clinical symptoms resolution in ILD/Pneumonitis participants who have been treated with high dose steroid (\>2 mg dexamethasone) were evaluated. |
Countries
Australia, Belgium, Canada, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORNadia Harbeck, MD, PhD
Head, Breast Center, Ludwig-Maximilians-University of Munich Department of Obstetrics and Gynecology Marchioninistr. 15, 81377 Munich, Germany
PRINCIPAL_INVESTIGATORNancy U. Lin, MD
Associate Chief, Division of Breast Oncology, Susan F. Smith Center for Women's Cancers Director, Metastatic Breast Cancer Program, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA 02215
Participant flow
Recruitment details
Participants were enrolled in this study from 22 June 2021 (First participant in) and the analyses presented in this results form are based on a final data cut-off of 08 February 2024 and final database lock of 22 April 2024.
Pre-assignment details
Participants meeting eligibility criteria predefined in protocol were enrolled in the study. Assessments were to be performed as per the schedule of the assessments. However, 2 participants were in early withdrawal status since they completed enrollment but never received any treatment.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) Participants without brain metastasis at baseline received T-DXd in Cohort 1 of the study. | 241 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) Participants with brain metastasis at baseline received T-DXd in Cohort 2 of the study. | 263 |
| Total | 504 |
Baseline characteristics
| Characteristic | Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Total | Cohort 1: Trastuzumab Deruxtecan (T-DXd) |
|---|---|---|---|
| Age, Continuous | 52.8 Years STANDARD_DEVIATION 11.2 | 53.8 Years STANDARD_DEVIATION 11.6 | 54.8 Years STANDARD_DEVIATION 11.9 |
| Race/Ethnicity, Customized Asian | 19 Participants | 34 Participants | 15 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 6 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 15 Participants | 35 Participants | 20 Participants |
| Race/Ethnicity, Customized Missing | 3 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 245 Participants | 464 Participants | 219 Participants |
| Race/Ethnicity, Customized Not reported | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 19 Participants | 13 Participants |
| Race/Ethnicity, Customized White | 231 Participants | 440 Participants | 209 Participants |
| Sex: Female, Male Female | 263 Participants | 504 Participants | 241 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 41 / 241 | 43 / 263 |
| other Total, other adverse events | 235 / 241 | 253 / 263 |
| serious Total, serious adverse events | 46 / 241 | 62 / 263 |
Outcome results
Primary
Objective Response Rate (ORR) in Cohort 1 (Participants Without Brain Metastasis at Baseline)
The ORR is defined as the percentage (%) of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as determined by independent central review (ICR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time frame: From first dose (Day 1) to progression of disease (up to 2 years 7 months)
Population: The full analysis set (FAS) included all participants who were enrolled in the study and received at least 1 dose of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Objective Response Rate (ORR) in Cohort 1 (Participants Without Brain Metastasis at Baseline) | 62.7 Percentage of participants |
Primary
Progression-free Survival (PFS) Rate at 12 Months in Cohort 2 (Participants With Brain Metastasis at Baseline)
The PFS rate is the percentage of participants alive and free of disease progression at 12 months, estimated by the Kaplan-Meier method.
Time frame: At 12 months
Population: The FAS set included all the participants who were enrolled in the study and received at least 1 dose of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Progression-free Survival (PFS) Rate at 12 Months in Cohort 2 (Participants With Brain Metastasis at Baseline) | 61.6 Percentage of participants |
Secondary
Central Nervous System Duration of Response in Participants With Brain Metastasis at Baseline (Cohort 2)
The CNS DoR is defined as the time from the date of first documented confirmed CNS response until date of documented CNS progression per CNS RECIST 1.1 as assessed by ICR or death due to any cause.
Time frame: From date of first documented confirmed CNS response until CNS progression of disease (up to 2 years 7 months)
Population: The FAS included all participants who were enrolled in the study and received at least 1 dose of treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Central Nervous System Duration of Response in Participants With Brain Metastasis at Baseline (Cohort 2) | NA Months |
Secondary
Central Nervous System Objective Response Rate in Participants With Brain Metastasis at Baseline by ICR (Cohort 2)
The CNS ORR is defined as the percentage of participants with measurable brain metastasis at baseline who have a confirmed CR or confirmed PR of brain lesions, as determined by ICR per CNS RECIST 1.1.
Time frame: From first dose (Day 1) until CNS progression of disease (up to 2 years 7 months)
Population: The FAS included all participants who were enrolled in the study and received at least 1 dose of treatment. Here, number of participants analyzed represents participants who had measurable CNS disease at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Central Nervous System Objective Response Rate in Participants With Brain Metastasis at Baseline by ICR (Cohort 2) | 71.7 Percentage of participants |
Secondary
Central Nervous System Progression-free Survival Rate at 12 Months in Participants With Brain Metastasis at Baseline (Cohort 2)
Central nervous system progression free survival rate is the percentage of participants free from central nervous system progression at 12 months, estimated by the Kaplan-Meier method.
Time frame: At 12 Months
Population: The FAS included all the participants who were enrolled in the study and received at least 1 dose of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Central Nervous System Progression-free Survival Rate at 12 Months in Participants With Brain Metastasis at Baseline (Cohort 2) | 58.9 Percentage of Participants |
Secondary
Cognitive Functions Tests: Paired Associates Learning (PAL) First Attempt Memory Score (PALFAMS)
The PAL is a computerized, self-completed cognitive test used to capture cognitive function, including attention, memory, and executive function. This gamified test included PAL and was a low-burden, highly sensitive, precise measure of cognitive function. The PALFAMS is the number of times a participant chose the correct box on their first attempt when recalling the pattern locations, calculated across all assessed trials. A higher number of events of selecting correct boxes indicates better cognitive function. Here, baseline was the last non-missing value prior to administration of the first dose of study intervention.
Time frame: Baseline, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, and Cycle 17 Day 1 (21 days cycle)
Population: The FAS included all the participants who were enrolled in the study and received at least 1 dose of treatment. The number analyzed refers to the number of participants included in the analysis at specific time points in each row.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Paired Associates Learning (PAL) First Attempt Memory Score (PALFAMS) | PAL first attempt Memory score: Cycle 5 Day 1 | 11.7 Number of Events | Standard Deviation 4.81 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Paired Associates Learning (PAL) First Attempt Memory Score (PALFAMS) | PAL first attempt Memory score: Cycle 13 Day 1 | 12.4 Number of Events | Standard Deviation 4.86 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Paired Associates Learning (PAL) First Attempt Memory Score (PALFAMS) | PAL first attempt Memory score: Cycle 9 Day 1 | 12.5 Number of Events | Standard Deviation 4.36 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Paired Associates Learning (PAL) First Attempt Memory Score (PALFAMS) | PAL first attempt Memory score: Cycle 17 Day 1 | 13.2 Number of Events | Standard Deviation 4.61 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Paired Associates Learning (PAL) First Attempt Memory Score (PALFAMS) | Paired Assistance Learning (PAL) first attempt Memory score: Baseline | 10.9 Number of Events | Standard Deviation 4.63 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Paired Associates Learning (PAL) First Attempt Memory Score (PALFAMS) | PAL first attempt Memory score: Cycle 17 Day 1 | 12.2 Number of Events | Standard Deviation 5.07 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Paired Associates Learning (PAL) First Attempt Memory Score (PALFAMS) | Paired Assistance Learning (PAL) first attempt Memory score: Baseline | 10.4 Number of Events | Standard Deviation 4.71 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Paired Associates Learning (PAL) First Attempt Memory Score (PALFAMS) | PAL first attempt Memory score: Cycle 5 Day 1 | 10.8 Number of Events | Standard Deviation 4.48 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Paired Associates Learning (PAL) First Attempt Memory Score (PALFAMS) | PAL first attempt Memory score: Cycle 9 Day 1 | 11.4 Number of Events | Standard Deviation 4.59 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Paired Associates Learning (PAL) First Attempt Memory Score (PALFAMS) | PAL first attempt Memory score: Cycle 13 Day 1 | 11.8 Number of Events | Standard Deviation 4.56 |
Secondary
Cognitive Functions Tests: Paired Associates Learning Total Errors Adjusted (PALTEA)
The PAL is a computerized, self-completed cognitive test used to capture cognitive function, including attention, memory, and executive function. This gamified test included PALTEA and was a low-burden, highly sensitive, precise measure of cognitive function. PALTEA is the number of times a participant chose the incorrect box for a stimulus on assessment problems, plus an adjustment for the estimated number of errors they would have made on any problems, attempts, and recalls they did not reach. A higher number of events of selecting incorrect boxes indicates worse cognitive function. Here, baseline was the last non-missing value prior to administration of the first dose of study intervention.
Time frame: Baseline, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, and Cycle 17 Day 1 (21 days cycle)
Population: The FAS included all the participants who were enrolled in the study and received at least 1 dose of treatment. The number analyzed refers to the number of participants included in the analysis at specific time points in each row.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Paired Associates Learning Total Errors Adjusted (PALTEA) | PAL Total Errors (Adjusted): Cycle 5 Day 1 | 19.2 Number of Events | Standard Deviation 16.47 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Paired Associates Learning Total Errors Adjusted (PALTEA) | PAL Total Errors (Adjusted): Cycle 13 Day 1 | 17.5 Number of Events | Standard Deviation 16.33 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Paired Associates Learning Total Errors Adjusted (PALTEA) | PAL Total Errors (Adjusted): Cycle 9 Day 1 | 17.2 Number of Events | Standard Deviation 15.17 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Paired Associates Learning Total Errors Adjusted (PALTEA) | PAL Total Errors (Adjusted): Cycle 17 Day 1 | 15.0 Number of Events | Standard Deviation 14.92 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Paired Associates Learning Total Errors Adjusted (PALTEA) | PAL Total Errors (Adjusted): Baseline | 21.8 Number of Events | Standard Deviation 17.18 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Paired Associates Learning Total Errors Adjusted (PALTEA) | PAL Total Errors (Adjusted): Cycle 17 Day 1 | 19.2 Number of Events | Standard Deviation 17.66 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Paired Associates Learning Total Errors Adjusted (PALTEA) | PAL Total Errors (Adjusted): Baseline | 24.8 Number of Events | Standard Deviation 17.59 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Paired Associates Learning Total Errors Adjusted (PALTEA) | PAL Total Errors (Adjusted): Cycle 5 Day 1 | 23.1 Number of Events | Standard Deviation 17.53 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Paired Associates Learning Total Errors Adjusted (PALTEA) | PAL Total Errors (Adjusted): Cycle 9 Day 1 | 21.5 Number of Events | Standard Deviation 17.32 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Paired Associates Learning Total Errors Adjusted (PALTEA) | PAL Total Errors (Adjusted): Cycle 13 Day 1 | 19.2 Number of Events | Standard Deviation 16.31 |
Secondary
Cognitive Functions Tests: Reaction Time (RTI)
This is a computerized, self-completed cognitive test used to capture cognitive function, including attention, memory, and executive function. This gamified test included Reaction Time Task (RTI) and was low-burden, highly sensitive, precise measures of cognitive function. RTI Median Five-Choice Movement Time: median time taken for a participant to release response button and select target stimulus after it flashed yellow on screen. Calculated across correct, assessed trials in which stimulus could appear in any one of five locations. RTI Median Five-Choice Reaction Time: median duration it took for a participant to release response button after presentation of target stimulus. Calculated across correct, assessed trials in which stimulus could appear in any one of five locations. Measured in milliseconds. Higher reaction times indicate worse cognitive function. Here, baseline was the last non-missing value prior to administration of the first dose of study intervention.
Time frame: Baseline, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, and Cycle 17 Day 1 (21 days cycle)
Population: The FAS included all the participants who were enrolled in the study and received at least 1 dose of treatment. The number analyzed refers to the number of participants included in the analysis at specific time points in each row.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Reaction Time (RTI) | RTI Median Five-Choice Movement Time: Cycle 5 Day 1 | 309.1 Millisecond (msec) | Standard Deviation 94.85 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Reaction Time (RTI) | RTI Median Five-Choice Movement Time: Cycle 9 Day 1 | 305.3 Millisecond (msec) | Standard Deviation 93.47 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Reaction Time (RTI) | RTI Median Five-Choice Reaction Time: Cycle 5 Day 1 | 408.7 Millisecond (msec) | Standard Deviation 119.26 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Reaction Time (RTI) | RTI Median Five-Choice Movement Time: Cycle 17 Day 1 | 319.6 Millisecond (msec) | Standard Deviation 151.42 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Reaction Time (RTI) | RTI Median Five-Choice Reaction Time: Cycle 9 Day 1 | 401.5 Millisecond (msec) | Standard Deviation 73.18 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Reaction Time (RTI) | RTI Median Five-Choice Movement Time: Cycle 13 Day 1 | 308.4 Millisecond (msec) | Standard Deviation 89.55 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Reaction Time (RTI) | RTI Median Five-Choice Reaction Time: Cycle 13 Day 1 | 401.0 Millisecond (msec) | Standard Deviation 63.56 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Reaction Time (RTI) | Reaction time (RTI) Median Five-Choice Movement Time: Baseline | 314.7 Millisecond (msec) | Standard Deviation 117.03 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Reaction Time (RTI) | RTI Median Five-Choice Reaction Time: Cycle 17 Day 1 | 396.8 Millisecond (msec) | Standard Deviation 81.63 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Reaction Time (RTI) | RTI Median Five-Choice Reaction Time: Baseline | 401.3 Millisecond (msec) | Standard Deviation 70.63 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Reaction Time (RTI) | RTI Median Five-Choice Reaction Time: Cycle 17 Day 1 | 402.8 Millisecond (msec) | Standard Deviation 51.93 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Reaction Time (RTI) | RTI Median Five-Choice Movement Time: Cycle 13 Day 1 | 324.1 Millisecond (msec) | Standard Deviation 115.24 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Reaction Time (RTI) | RTI Median Five-Choice Movement Time: Cycle 17 Day 1 | 316.4 Millisecond (msec) | Standard Deviation 96.69 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Reaction Time (RTI) | RTI Median Five-Choice Reaction Time: Baseline | 423.6 Millisecond (msec) | Standard Deviation 115.56 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Reaction Time (RTI) | RTI Median Five-Choice Movement Time: Cycle 5 Day 1 | 310.5 Millisecond (msec) | Standard Deviation 110.94 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Reaction Time (RTI) | Reaction time (RTI) Median Five-Choice Movement Time: Baseline | 329.4 Millisecond (msec) | Standard Deviation 141.24 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Reaction Time (RTI) | RTI Median Five-Choice Reaction Time: Cycle 5 Day 1 | 413.0 Millisecond (msec) | Standard Deviation 84.25 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Reaction Time (RTI) | RTI Median Five-Choice Reaction Time: Cycle 9 Day 1 | 414.5 Millisecond (msec) | Standard Deviation 67.68 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Reaction Time (RTI) | RTI Median Five-Choice Reaction Time: Cycle 13 Day 1 | 412.3 Millisecond (msec) | Standard Deviation 77.07 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Reaction Time (RTI) | RTI Median Five-Choice Movement Time: Cycle 9 Day 1 | 326.7 Millisecond (msec) | Standard Deviation 106.02 |
Secondary
Cognitive Functions Tests: Spatial Working Memory Strategy (SWMS)
The SWM is a computerized cognitive test. The SWMS, the number of times a participant restarted search patterns from the same initial box, indicating their use of a planned strategy to find tokens. An increased number of events where search patterns started from the same initial box suggested participants were using a planned strategy to find tokens, which indicated better cognitive function. Here, a low score indicated high strategy use (1 = they always began the search from the same box). Conversely, high scores represented a decrease in events of beginning searches from the same box. Instead, starting from many different boxes suggested the participant was not using a consistent strategy, which indicated worse cognitive function. This was calculated across assessed trials with 6 tokens or more. Here, baseline was the last non-missing value prior to administration of the first dose of study intervention.
Time frame: Baseline, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, and Cycle 17 Day 1 (21 days cycle)
Population: The FAS included all the participants who were enrolled in the study and received at least 1 dose of treatment. The number analyzed refers to the number of participants included in the analysis at specific time points in each row.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory Strategy (SWMS) | SWM Strategy (6-8 Boxes): Baseline | 8.8 Number of Events | Standard Deviation 2.3 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory Strategy (SWMS) | SWM Strategy (6-8 Boxes): Cycle 13 Day 1 | 7.9 Number of Events | Standard Deviation 3.18 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory Strategy (SWMS) | SWM Strategy (6-8 Boxes): Cycle 5 Day 1 | 8.4 Number of Events | Standard Deviation 2.8 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory Strategy (SWMS) | SWM Strategy (6-8 Boxes): Cycle 17 Day 1 | 7.9 Number of Events | Standard Deviation 3.13 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory Strategy (SWMS) | SWM Strategy (6-8 Boxes): Cycle 9 Day 1 | 8.2 Number of Events | Standard Deviation 2.7 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory Strategy (SWMS) | SWM Strategy (6-8 Boxes): Cycle 17 Day 1 | 8.0 Number of Events | Standard Deviation 3.08 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory Strategy (SWMS) | SWM Strategy (6-8 Boxes): Baseline | 9.1 Number of Events | Standard Deviation 2.32 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory Strategy (SWMS) | SWM Strategy (6-8 Boxes): Cycle 9 Day 1 | 8.5 Number of Events | Standard Deviation 2.44 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory Strategy (SWMS) | SWM Strategy (6-8 Boxes): Cycle 13 Day 1 | 8.6 Number of Events | Standard Deviation 2.79 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory Strategy (SWMS) | SWM Strategy (6-8 Boxes): Cycle 5 Day 1 | 8.8 Number of Events | Standard Deviation 2.42 |
Secondary
Cognitive Functions Tests: Spatial Working Memory (SWM)
The SWM is a computerized cognitive test. The SWM Between Errors (SWMBE) is number of times a participant incorrectly revisits a box in which a token has previously been found, calculated across all 4, 6, and 8 token trials. SWM Between Errors 4 Boxes (SWMBE4), SWM Between Errors 6 Boxes (SWMBE6), and SWM Between Errors 8 Boxes (SWMBE8) are number of times a participant revisits a box in which a token has previously been found. These are calculated across all trials with 4 tokens only for SWMBE4, 6 tokens only for SWMBE6, and 8 tokens only for SWMBE8. SWM Total Errors is number of times a box is selected that is certain not to contain a token and therefore should not have been visited by participant. A higher number of incorrect revisit events to previously found token boxes indicates worse cognitive function, and a lower number of revisit events indicates better cognitive function. Here, baseline was last non-missing value prior to administration of first dose of study intervention.
Time frame: Baseline, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, and Cycle 17 Day 1 (21 days cycle)
Population: The FAS included all the participants who were enrolled in the study and received at least 1 dose of treatment. The number analyzed refers to the number of participants included in the analysis at specific time points in each row.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors: Cycle 5 Day 1 | 15.5 Number of Events | Standard Deviation 10.11 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 6 Boxes: Cycle 9 Day 1 | 4.2 Number of Events | Standard Deviation 3.64 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 4 Boxes: Cycle 5 Day 1 | 1.0 Number of Events | Standard Deviation 1.39 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 6 Boxes: Cycle 13 Day 1 | 3.2 Number of Events | Standard Deviation 3.38 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors: Cycle 13 Day 1 | 13.4 Number of Events | Standard Deviation 9.56 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 6 Boxes: Cycle 17 Day 1 | 3.7 Number of Events | Standard Deviation 3.25 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 4 Boxes: Cycle 9 Day 1 | 0.9 Number of Events | Standard Deviation 1.33 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 8 Boxes: Baseline | 10.9 Number of Events | Standard Deviation 5.66 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | Spatial working memory (SWM) Between Errors: Baseline | 17.2 Number of Events | Standard Deviation 8.89 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 8 Boxes: Cycle 5 Day 1 | 10.2 Number of Events | Standard Deviation 6.61 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 4 Boxes: Cycle 13 Day 1 | 0.8 Number of Events | Standard Deviation 1.23 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 8 Boxes: Cycle 9 Day 1 | 10.0 Number of Events | Standard Deviation 6.31 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors: Cycle 17 Day 1 | 13.5 Number of Events | Standard Deviation 9.48 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 8 Boxes: Cycle 13 Day 1 | 9.3 Number of Events | Standard Deviation 6.27 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 4 Boxes: Cycle 17 Day 1 | 0.9 Number of Events | Standard Deviation 1.32 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 8 Boxes: Cycle 17 Day 1 | 8.9 Number of Events | Standard Deviation 6.42 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors: Cycle 9 Day 1 | 15.1 Number of Events | Standard Deviation 9.78 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Total Errors: Baseline | 17.5 Number of Events | Standard Deviation 8.96 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 6 Boxes: Baseline | 5.0 Number of Events | Standard Deviation 3.44 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Total Errors: Cycle 5 Day 1 | 15.9 Number of Events | Standard Deviation 10.24 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 4 Boxes: Baseline | 1.4 Number of Events | Standard Deviation 1.39 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Total Errors: Cycle 13 Day 1 | 13.7 Number of Events | Standard Deviation 9.71 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 6 Boxes: Cycle 5 Day 1 | 4.3 Number of Events | Standard Deviation 3.41 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Total Errors: Cycle 17 Day 1 | 13.8 Number of Events | Standard Deviation 9.63 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Total Errors: Cycle 9 Day 1 | 15.5 Number of Events | Standard Deviation 9.89 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Total Errors: Cycle 17 Day 1 | 13.9 Number of Events | Standard Deviation 9.63 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Total Errors: Cycle 9 Day 1 | 16.7 Number of Events | Standard Deviation 9.42 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | Spatial working memory (SWM) Between Errors: Baseline | 18.6 Number of Events | Standard Deviation 8.69 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors: Cycle 5 Day 1 | 16.8 Number of Events | Standard Deviation 8.39 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors: Cycle 9 Day 1 | 16.3 Number of Events | Standard Deviation 9.22 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors: Cycle 13 Day 1 | 15.0 Number of Events | Standard Deviation 8.85 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors: Cycle 17 Day 1 | 13.7 Number of Events | Standard Deviation 9.5 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 4 Boxes: Baseline | 1.4 Number of Events | Standard Deviation 1.46 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 4 Boxes: Cycle 5 Day 1 | 1.1 Number of Events | Standard Deviation 1.42 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 4 Boxes: Cycle 9 Day 1 | 1.1 Number of Events | Standard Deviation 1.42 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 4 Boxes: Cycle 13 Day 1 | 0.9 Number of Events | Standard Deviation 1.37 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 4 Boxes: Cycle 17 Day 1 | 0.7 Number of Events | Standard Deviation 1.17 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 6 Boxes: Baseline | 5.2 Number of Events | Standard Deviation 3.53 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 6 Boxes: Cycle 5 Day 1 | 4.6 Number of Events | Standard Deviation 3.42 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 6 Boxes: Cycle 9 Day 1 | 4.7 Number of Events | Standard Deviation 3.84 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 6 Boxes: Cycle 13 Day 1 | 4.1 Number of Events | Standard Deviation 3.34 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 6 Boxes: Cycle 17 Day 1 | 4.0 Number of Events | Standard Deviation 3.51 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 8 Boxes: Baseline | 12.1 Number of Events | Standard Deviation 5.45 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 8 Boxes: Cycle 5 Day 1 | 11.2 Number of Events | Standard Deviation 5.31 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 8 Boxes: Cycle 9 Day 1 | 10.5 Number of Events | Standard Deviation 5.52 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 8 Boxes: Cycle 13 Day 1 | 9.9 Number of Events | Standard Deviation 5.91 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Between Errors 8 Boxes: Cycle 17 Day 1 | 9.0 Number of Events | Standard Deviation 6.33 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Total Errors: Baseline | 19.0 Number of Events | Standard Deviation 8.75 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Total Errors: Cycle 5 Day 1 | 17.3 Number of Events | Standard Deviation 8.59 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Cognitive Functions Tests: Spatial Working Memory (SWM) | SWM Total Errors: Cycle 13 Day 1 | 15.3 Number of Events | Standard Deviation 8.91 |
Secondary
Duration of Response (DoR)
Duration of response is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 as assessed by ICR or death due to any cause.
Time frame: From the date of first documented confirmed response until date of documented progression (up to 2 years 7 months)
Population: The FAS included all participants who were enrolled in the study and received at least 1 dose of treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Duration of Response (DoR) | NA Months |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Duration of Response (DoR) | NA Months |
Secondary
Duration of Treatment on Subsequent Lines of Therapy
Duration of treatment on subsequent therapy is defined as the time from the date of first dose of a subsequent therapy until date of the last dose of that therapy.
Time frame: From the date of first dose of a subsequent therapy until date of last dose of therapy (up to 2 years 7 months)
Population: The Full analysis set-subsequent therapy included all participants in FAS had RECIST progression, as assessed by investigator, during the study and received subsequent anti-cancer therapy. The number analyzed refers to the number of participants included in analysis in specific time points in each row.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Duration of Treatment on Subsequent Lines of Therapy | First subsequent line of therapy | 4.4 Months |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Duration of Treatment on Subsequent Lines of Therapy | First completed subsequent line of therapy | 3.0 Months |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Duration of Treatment on Subsequent Lines of Therapy | First subsequent line of therapy | 6.5 Months |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Duration of Treatment on Subsequent Lines of Therapy | First completed subsequent line of therapy | 3.0 Months |
Secondary
Incidence of New Symptomatic Central Nervous System (CNS) Metastasis During Treatment Without CNS Metastasis at Baseline (Cohort 1)
The incidence rate is defined as proportion of participants with new symptomatic CNS metastases during treatment period in participants without symptomatic CNS metastasis at baseline.
Time frame: From first dose (Day 1) to end of treatment (up to 2 years 7 months)
Population: The FAS included all the participants who were involved in the study and received at least 1 dose of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Incidence of New Symptomatic Central Nervous System (CNS) Metastasis During Treatment Without CNS Metastasis at Baseline (Cohort 1) | 0.017 Proportion of participants |
Secondary
MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants
The T-DXd on symptoms, functioning, and HRQoL in HER2+ MBC participants with or without baseline brain metastasis was evaluated. The MDASI brain tumor module includes 9 symptoms specific to brain tumors (weakness on one side of the body, difficulty understanding, difficulty speaking, seizures, difficulty concentrating, problems with vision, change in appearance, change in bowel pattern (diarrhea or constipation), and irritability). These 9 items will be used to capture symptoms associated with brain metastasis for those diagnosed with brain metastasis. Each item is rated on an 11-point numeric rating scale on a scale of 0-10, with higher scores indicating greater symptom severity. Here, baseline was the last non-missing value prior to administration of the first dose of study intervention.
Time frame: Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, and Cycle 39 Day 1 (21 days cycle)
Population: The FAS included all the participants who were enrolled in the study and received at least 1 dose of treatment. The number analyzed refers to the number of participants included in the analysis at specific time points in each row.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Change in Bowel Pattern at Its Worst: Baseline | 1.7 Score on scale | Standard Deviation 2.46 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Difficulty Concentrating at Its Worst: Cycle 3 Day 1 | 1.9 Score on scale | Standard Deviation 2.27 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Difficulty Concentrating at Its Worst: Cycle 5 Day 1 | 1.5 Score on scale | Standard Deviation 1.95 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Change in Appearance at Its Worst: Baseline | 1.8 Score on scale | Standard Deviation 2.44 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Change in Appearance at Its Worst: Cycle 2 Day 1 | 1.9 Score on scale | Standard Deviation 2.44 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Change in Appearance at Its Worst: Cycle 3 Day 1 | 2.1 Score on scale | Standard Deviation 2.51 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Change in Appearance at Its Worst: Cycle 4 Day 1 | 1.9 Score on scale | Standard Deviation 2.2 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Change in Appearance at Its Worst: Cycle 5 Day 1 | 2.1 Score on scale | Standard Deviation 2.45 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Change in Appearance at Its Worst: Cycle 39 Day 1 | 3.0 Score on scale | — |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Change in Bowel Pattern at Its Worst: Cycle 2 Day 1 | 2.5 Score on scale | Standard Deviation 2.55 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Change in Bowel Pattern at Its Worst: Cycle 3 Day 1 | 2.7 Score on scale | Standard Deviation 2.67 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Change in Bowel Pattern at Its Worst: Cycle 4 Day 1 | 3.0 Score on scale | Standard Deviation 2.74 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Change in Bowel Pattern at Its Worst: Cycle 5 Day 1 | 2.8 Score on scale | Standard Deviation 2.69 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Change in Bowel Pattern at Its Worst: Cycle 39 Day 1 | 0 Score on scale | — |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Difficulty Concentrating at Its Worst: Baseline | 1.8 Score on scale | Standard Deviation 2.23 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Difficulty Concentrating at Its Worst: Cycle 2 Day 1 | 1.7 Score on scale | Standard Deviation 2.03 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Difficulty Concentrating at Its Worst: Cycle 4 Day 1 | 1.6 Score on scale | Standard Deviation 2.03 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Difficulty Concentrating at Its Worst: Cycle 39 Day 1 | 1.0 Score on scale | — |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Difficulty Speaking at Its Worst: Baseline | 1.4 Score on scale | Standard Deviation 2.18 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Difficulty Speaking at Its Worst: Cycle 2 Day 1 | 1.3 Score on scale | Standard Deviation 1.96 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Difficulty Speaking at Its Worst: Cycle 3 Day 1 | 1.4 Score on scale | Standard Deviation 1.97 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Difficulty Speaking at Its Worst: Cycle 4 Day 1 | 1.1 Score on scale | Standard Deviation 1.8 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Difficulty Speaking at Its Worst: Cycle 5 Day 1 | 1.3 Score on scale | Standard Deviation 1.98 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Difficulty Speaking at Its Worst: Cycle 39 Day 1 | 1.0 Score on scale | — |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Difficulty Understanding at Its Worst: Baseline | 1.5 Score on scale | Standard Deviation 2.29 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Difficulty Understanding at Its Worst: Cycle 2 Day 1 | 0.9 Score on scale | Standard Deviation 1.67 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Difficulty Understanding at Its Worst: Cycle 3 Day 1 | 1.2 Score on scale | Standard Deviation 1.87 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Difficulty Understanding at Its Worst: Cycle 4 Day 1 | 1.0 Score on scale | Standard Deviation 1.83 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Difficulty Understanding at Its Worst: Cycle 5 Day 1 | 0.9 Score on scale | Standard Deviation 1.68 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Difficulty Understanding at Its Worst: Cycle 39 Day 1 | 0 Score on scale | — |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Irritability at its Worst: Baseline | 1.8 Score on scale | Standard Deviation 2.27 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Irritability at its Worst: Cycle 2 Day 1 | 1.9 Score on scale | Standard Deviation 2.23 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Irritability at its Worst: Cycle 3 Day 1 | 1.8 Score on scale | Standard Deviation 2.04 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Irritability at its Worst: Cycle 4 Day 1 | 1.9 Score on scale | Standard Deviation 2.06 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Irritability at its Worst: Cycle 5 Day 1 | 1.9 Score on scale | Standard Deviation 2.12 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Irritability at its Worst: Cycle 39 Day 1 | 4.0 Score on scale | — |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Seizures at Its Worst: Baseline | 0.5 Score on scale | Standard Deviation 1.58 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Seizures at Its Worst: Cycle 2 Day 1 | 0.5 Score on scale | Standard Deviation 1.38 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Seizures at Its Worst: Cycle 3 Day 1 | 0.5 Score on scale | Standard Deviation 1.52 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Seizures at Its Worst: Cycle 4 Day 1 | 0.5 Score on scale | Standard Deviation 1.47 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Seizures at Its Worst: Cycle 5 Day 1 | 0.5 Score on scale | Standard Deviation 1.4 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Seizures at Its Worst: Cycle 39 Day 1 | 0 Score on scale | — |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Vision at Its Worst: Baseline | 1.6 Score on scale | Standard Deviation 2.28 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Vision at Its Worst: Cycle 2 Day 1 | 1.6 Score on scale | Standard Deviation 2.24 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Vision at Its Worst: Cycle 3 Day 1 | 1.5 Score on scale | Standard Deviation 2.1 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Vision at Its Worst: Cycle 4 Day 1 | 1.4 Score on scale | Standard Deviation 1.94 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Vision at Its Worst: Cycle 5 Day 1 | 1.5 Score on scale | Standard Deviation 2.01 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Vision at Its Worst: Cycle 39 Day 1 | 1.0 Score on scale | — |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Weakness on One Body Side at Its Worst: Baseline | 2.1 Score on scale | Standard Deviation 2.54 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Weakness on One Body Side at Its Worst: Cycle 2 Day 1 | 1.7 Score on scale | Standard Deviation 2.35 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Weakness on One Body Side at Its Worst: Cycle 3 Day 1 | 1.8 Score on scale | Standard Deviation 2.28 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Weakness on One Body Side at Its Worst: Cycle 4 Day 1 | 1.8 Score on scale | Standard Deviation 2.48 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Weakness on One Body Side at Its Worst: Cycle 5 Day 1 | 1.6 Score on scale | Standard Deviation 2.18 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | MD Anderson Symptom Inventory Brain Tumor-Specific Items in Brain Metastasis at Baseline Participants | Weakness on One Body Side at Its Worst: Cycle 39 Day 1 | 0 Score on scale | — |
Secondary
Number of Participants With Adverse Events (AEs)
The safety and tolerability of the participants who received T-DXd was evaluated. SAE=Serious adverse events; CTCAE=Common Terminology for Adverse Events
Time frame: From first dose until end of safety follow-up (47 days post last dose) (up to 2 years 7 months)
Population: The Safety analysis set included all participants who had received at least 1 dose of treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any SAE (events with outcome = death) | 46 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE leading to dose reduction | 65 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE of CTCAE grade 3 or higher | 118 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE leading to dose reduction, possibly related to treatment | 63 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE leading to dose interruption, possibly related to treatment | 82 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE leading to dose interruption | 124 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE of CTCAE grade 3 or higher, possibly related to treatment | 98 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE, excluding AEs associated with COVID-19 | 237 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE leading to discontinuation of treatment | 23 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE with outcome = death | 6 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE leading to discontinuation of treatment, excluding AEs associated with COVID-19 | 23 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any SAE (events with outcome = death), possibly related to treatment | 25 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE leading to discontinuation of treatment, associated with COVID-19 | 0 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE with outcome = death, excluding AEs associated with COVID-19 | 6 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE leading to discontinuation of treatment, possibly related to treatment | 20 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE associated with COVID-19 | 45 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any SAE leading to discontinuation of treatment | 8 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE with outcome = death, associated with COVID-19 | 0 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any SAE leading to discontinuation of treatment, possibly related to treatment | 6 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE | 237 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any Other Adverse events (OAE) | 0 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE with outcome = death, possibly related to treatment | 5 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any Adverse event of special event | 54 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE possibly related to treatment | 230 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any Adverse event of special event | 71 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any SAE (events with outcome = death), possibly related to treatment | 25 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE possibly related to treatment | 242 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE | 259 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE, excluding AEs associated with COVID-19 | 259 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE associated with COVID-19 | 54 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE of CTCAE grade 3 or higher | 134 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE of CTCAE grade 3 or higher, possibly related to treatment | 100 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE with outcome = death | 8 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE with outcome = death, excluding AEs associated with COVID-19 | 8 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE with outcome = death, associated with COVID-19 | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE with outcome = death, possibly related to treatment | 6 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE leading to dose reduction | 60 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE leading to dose reduction, possibly related to treatment | 53 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE leading to dose interruption | 146 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE leading to dose interruption, possibly related to treatment | 83 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE leading to discontinuation of treatment | 40 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE leading to discontinuation of treatment, excluding AEs associated with COVID-19 | 39 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE leading to discontinuation of treatment, associated with COVID-19 | 1 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any AE leading to discontinuation of treatment, possibly related to treatment | 34 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any SAE leading to discontinuation of treatment | 18 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any SAE leading to discontinuation of treatment, possibly related to treatment | 13 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any Other Adverse events (OAE) | 5 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Adverse Events (AEs) | Any SAE (events with outcome = death) | 62 Participants |
Secondary
Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30)
The EORTC QLQ-C30 is a 30-item questionnaire for cancer assessment. Increased scores indicate improvement; decreased scores indicate deterioration. Physical function: ≥+9= improvement, ≤-10=deterioration, otherwise=no change; Role functioning: ≤-6=deterioration, otherwise=no change; Social functioning: ≥+8=improvement, ≤-7=deterioration, otherwise=no change; Cognitive functioning: ≥+ 5=improvement, ≤- 4=deterioration, otherwise=no change; Global Health Status: ≥+2=improvement, ≤-8=deterioration, otherwise=no change; Fatigue: ≥+8=improvement, ≤-8=deterioration, otherwise=no change; Nausea and vomiting: ≤-11=deterioration, otherwise=no change; Appetite loss: ≤-14=deterioration, otherwise=no change; rest of scales: ≥+10=improvement, ≤-10=deterioration, otherwise=no change. Best on treatment response is best response category (improvement, no change, and deterioration) achieved by participants between first dose and 47 days after last dose, and prior to starting any anticancer therapy.
Time frame: Time from first dose up to 47 days after last dose, or prior to starting any subsequent therapy, or for up to 2 years 7 months, whichever occurred first
Population: The safety analysis set included all the participants who have received at least 1 dose of treatment. The overall number of participants analyzed represents only participants who were not missing baseline data. The number analyzed refers to the number of participants included in each row for each response category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Diarrhoea: Best on-treatment response: Missing | 0 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Appetite loss: Best on-treatment response: No change | 171 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Appetite loss: Best on-treatment response: No follow-up | 21 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Appetite loss: Best on-treatment response: Missing | 0 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Cognitive Functioning: Best on-treatment response: Deterioration | 16 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Cognitive Functioning: Best on-treatment response: Improvement | 57 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Cognitive Functioning: Best on-treatment response: No change | 116 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Cognitive Functioning: Best on-treatment response: No follow-up | 18 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Cognitive Functioning: Best on-treatment response: Missing | 0 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Constipation: Best on-treatment response: Deterioration | 18 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Constipation: Best on-treatment response: Improvement | 36 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Constipation: Best on-treatment response: No change | 134 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Constipation: Best on-treatment response: No follow-up | 19 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Constipation: Best on-treatment response: Missing | 0 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Diarrhoea: Best on-treatment response: Deterioration | 2 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Diarrhoea: Best on-treatment response: Improvement | 32 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Diarrhoea: Best on-treatment response: No change | 153 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Diarrhoea: Best on-treatment response: No follow-up | 20 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Appetite loss: Best on-treatment response: Deterioration | 15 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Dyspnea: Best on-treatment response: Deterioration | 6 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Dyspnea: Best on-treatment response: Improvement | 48 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Dyspnea: Best on-treatment response: No change | 131 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Dyspnea: Cycle Best on-treatment response: No follow-up | 22 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Dyspnea: Best on-treatment response: Missing | 0 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Emotional Functioning: Best on-treatment response: Deterioration | 4 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Emotional Functioning: Best on-treatment response: Improvement | 109 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Emotional Functioning: Best on-treatment response: No change | 77 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Emotional Functioning: Best on-treatment response: No follow-up | 17 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Emotional Functioning: Best on-treatment response: Missing | 0 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Fatigue: Best on-treatment response: Deterioration | 28 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Fatigue: Best on-treatment response: Improvement | 97 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Fatigue: Best on-treatment response: No change | 65 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Fatigue: Best on-treatment response: No follow-up | 17 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Fatigue: Best on-treatment response: Missing | 0 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Financial difficulties: Best on-treatment response: Deterioration | 7 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Financial difficulties: Best on-treatment response: Improvement | 46 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Financial difficulties: Best on-treatment response: No change | 135 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Financial difficulties: Best on-treatment response: No follow-up | 18 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Financial difficulties: Best on-treatment response: Missing | 0 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Global health status / QoL: Best on-treatment response: Deterioration | 28 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Global health status / QoL: Best on-treatment response: Improvement | 86 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Global health status / QoL: Best on-treatment response: No change | 75 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Global health status / QoL: Best on-treatment response: No follow-up | 18 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Global health status / QoL: Best on-treatment response: Missing | 0 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Insomnia: Best on-treatment response: Deterioration | 8 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Insomnia: Best on-treatment response: Improvement | 87 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Insomnia: Best on-treatment response: No change | 92 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Insomnia: Best on-treatment response: No follow-up | 20 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Insomnia: Best on-treatment response: Missing | 0 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Nausea and vomiting: Best on-treatment response: Deterioration | 17 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Nausea and vomiting: Best on-treatment response: No change | 167 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Nausea and vomiting: Best on-treatment response: No follow-up | 23 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Nausea and vomiting: Best on-treatment response: Missing | 0 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Pain: Best on-treatment response: Deterioration | 4 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Pain: Best on-treatment response: Improvement | 91 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Pain: Best on-treatment response: No change | 94 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Pain: Best on-treatment response: No follow-up | 18 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Pain: Best on-treatment response: Missing | 0 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Physical Functioning: Best on-treatment response: Deterioration | 10 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Physical Functioning: Best on-treatment response: Improvement | 54 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Physical Functioning: Best on-treatment response: No change | 122 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Physical Functioning: Best on-treatment response: No follow-up | 21 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Physical Functioning: Best on-treatment response: Missing | 0 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Role Functioning: Best on-treatment response: Deterioration | 20 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Role Functioning: Best on-treatment response: No change | 167 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Role Functioning: Best on-treatment response: No follow-up | 20 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Role Functioning: Best on-treatment response: Missing | 0 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Social Functioning: Best on-treatment response: Deterioration | 19 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Social Functioning: Best on-treatment response: Improvement | 81 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Social Functioning: Best on-treatment response: No change | 87 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Social Functioning: Best on-treatment response: No follow-up | 20 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Social Functioning: Best on-treatment response: Missing | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Social Functioning: Best on-treatment response: Deterioration | 16 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Appetite loss: Best on-treatment response: Deterioration | 9 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Financial difficulties: Best on-treatment response: No change | 140 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Appetite loss: Best on-treatment response: No change | 200 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Pain: Best on-treatment response: Improvement | 115 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Appetite loss: Best on-treatment response: No follow-up | 15 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Financial difficulties: Best on-treatment response: No follow-up | 16 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Appetite loss: Best on-treatment response: Missing | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Role Functioning: Best on-treatment response: Deterioration | 15 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Cognitive Functioning: Best on-treatment response: Deterioration | 12 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Financial difficulties: Best on-treatment response: Missing | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Cognitive Functioning: Best on-treatment response: Improvement | 87 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Pain: Best on-treatment response: No change | 89 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Cognitive Functioning: Best on-treatment response: No change | 107 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Global health status / QoL: Best on-treatment response: Deterioration | 34 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Cognitive Functioning: Best on-treatment response: No follow-up | 17 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Social Functioning: Best on-treatment response: Missing | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Cognitive Functioning: Best on-treatment response: Missing | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Global health status / QoL: Best on-treatment response: Improvement | 111 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Constipation: Best on-treatment response: Deterioration | 13 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Pain: Best on-treatment response: No follow-up | 12 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Constipation: Best on-treatment response: Improvement | 59 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Global health status / QoL: Best on-treatment response: No change | 65 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Constipation: Best on-treatment response: No change | 139 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Role Functioning: Best on-treatment response: No change | 197 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Constipation: Best on-treatment response: No follow-up | 13 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Global health status / QoL: Best on-treatment response: No follow-up | 13 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Constipation: Best on-treatment response: Missing | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Pain: Best on-treatment response: Missing | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Diarrhoea: Best on-treatment response: Deterioration | 4 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Global health status / QoL: Best on-treatment response: Missing | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Diarrhoea: Best on-treatment response: Improvement | 28 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Social Functioning: Best on-treatment response: Improvement | 109 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Diarrhoea: Best on-treatment response: No change | 174 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Insomnia: Best on-treatment response: Deterioration | 7 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Diarrhoea: Best on-treatment response: No follow-up | 17 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Physical Functioning: Best on-treatment response: Deterioration | 13 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Diarrhoea: Best on-treatment response: Missing | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Insomnia: Best on-treatment response: Improvement | 103 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Dyspnea: Best on-treatment response: Deterioration | 5 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Role Functioning: Best on-treatment response: No follow-up | 12 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Dyspnea: Best on-treatment response: Improvement | 49 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Insomnia: Best on-treatment response: No change | 98 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Dyspnea: Best on-treatment response: No change | 154 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Physical Functioning: Best on-treatment response: Improvement | 71 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Dyspnea: Cycle Best on-treatment response: No follow-up | 16 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Insomnia: Best on-treatment response: No follow-up | 16 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Dyspnea: Best on-treatment response: Missing | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Social Functioning: Best on-treatment response: No follow-up | 15 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Emotional Functioning: Best on-treatment response: Deterioration | 7 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Insomnia: Best on-treatment response: Missing | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Emotional Functioning: Best on-treatment response: Improvement | 98 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Physical Functioning: Best on-treatment response: No change | 124 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Emotional Functioning: Best on-treatment response: No change | 103 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Nausea and vomiting: Best on-treatment response: Deterioration | 9 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Emotional Functioning: Best on-treatment response: No follow-up | 15 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Role Functioning: Best on-treatment response: Missing | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Emotional Functioning: Best on-treatment response: Missing | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Nausea and vomiting: Best on-treatment response: No change | 201 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Fatigue: Best on-treatment response: Deterioration | 23 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Physical Functioning: Best on-treatment response: No follow-up | 16 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Fatigue: Best on-treatment response: Improvement | 119 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Nausea and vomiting: Best on-treatment response: No follow-up | 14 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Fatigue: Best on-treatment response: No change | 68 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Social Functioning: Best on-treatment response: No change | 83 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Fatigue: Best on-treatment response: No follow-up | 14 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Nausea and vomiting: Best on-treatment response: Missing | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Fatigue: Best on-treatment response: Missing | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Physical Functioning: Best on-treatment response: Missing | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Financial difficulties: Best on-treatment response: Deterioration | 9 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Pain: Best on-treatment response: Deterioration | 8 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Best on Treatment Visit Response on the European Organization for the Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Financial difficulties: Best on-treatment response: Improvement | 58 Participants |
Secondary
Number of Participants With ILD Clinical Symptoms Resolution Among ILD/Pneumonitis Participants Who Have Been Treated With High Dose Steroid
The number of participants with ILD clinical symptoms resolution in ILD/Pneumonitis participants who have been treated with high dose steroid (\>2 mg dexamethasone) were evaluated.
Time frame: From first dose until end of safety follow-up (47 days post last dose) (up to 2 years 7 months)
Population: The Safety analysis set-ILD consisted of all participants who had developed ILD/Pneumonitis. Here, the overall number of participants analyzed represents those who were treated with a high dose of steroids. Participants could have multiple ILD events with different statuses.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With ILD Clinical Symptoms Resolution Among ILD/Pneumonitis Participants Who Have Been Treated With High Dose Steroid | Resolved: Recovering/resolving | 1 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With ILD Clinical Symptoms Resolution Among ILD/Pneumonitis Participants Who Have Been Treated With High Dose Steroid | Unresolved: Not recovered/resolved | 6 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With ILD Clinical Symptoms Resolution Among ILD/Pneumonitis Participants Who Have Been Treated With High Dose Steroid | Resolved: Recovered/resolved with sequelae | 1 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With ILD Clinical Symptoms Resolution Among ILD/Pneumonitis Participants Who Have Been Treated With High Dose Steroid | Unresolved: Fatal | 3 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With ILD Clinical Symptoms Resolution Among ILD/Pneumonitis Participants Who Have Been Treated With High Dose Steroid | Resolved: Recovered/resolved | 18 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With ILD Clinical Symptoms Resolution Among ILD/Pneumonitis Participants Who Have Been Treated With High Dose Steroid | Unresolved: Fatal | 6 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With ILD Clinical Symptoms Resolution Among ILD/Pneumonitis Participants Who Have Been Treated With High Dose Steroid | Resolved: Recovered/resolved | 24 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With ILD Clinical Symptoms Resolution Among ILD/Pneumonitis Participants Who Have Been Treated With High Dose Steroid | Resolved: Recovering/resolving | 2 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With ILD Clinical Symptoms Resolution Among ILD/Pneumonitis Participants Who Have Been Treated With High Dose Steroid | Resolved: Recovered/resolved with sequelae | 1 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With ILD Clinical Symptoms Resolution Among ILD/Pneumonitis Participants Who Have Been Treated With High Dose Steroid | Unresolved: Not recovered/resolved | 6 Participants |
Secondary
Number of Participants With Investigator-assessed ILD/Pneumonitis
The number of participants with ILD/Pneumonitis were by grouped term based on Investigator-reported preferred terms. No adjudication was performed.
Time frame: From first dose until end of safety follow-up (47 days post last dose) (up to 2 years 7 months)
Population: The Safety analysis set consisted of all participants who had received at least 1 dose of treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Investigator-assessed ILD/Pneumonitis | Interstitial lung disease | 19 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Investigator-assessed ILD/Pneumonitis | Lung opacity | 2 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Investigator-assessed ILD/Pneumonitis | Pneumonitis | 10 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Investigator-assessed ILD/Pneumonitis | Pulmonary fibrosis | 1 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Investigator-assessed ILD/Pneumonitis | Radiation pneumonitis | 1 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Investigator-assessed ILD/Pneumonitis | Lung infiltration | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Investigator-assessed ILD/Pneumonitis | Radiation pneumonitis | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Investigator-assessed ILD/Pneumonitis | Interstitial lung disease | 17 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Investigator-assessed ILD/Pneumonitis | Pulmonary fibrosis | 1 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Investigator-assessed ILD/Pneumonitis | Lung opacity | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Investigator-assessed ILD/Pneumonitis | Lung infiltration | 1 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Investigator-assessed ILD/Pneumonitis | Pneumonitis | 24 Participants |
Secondary
Number of Participants With Neurologic Assessment in Neuro-Oncology Scale (NANO Scale)
The NANO scale is a clinician-reported assessment of neurologic functioning in neuro-oncology participants. The instrument captures 9 domains (gait, strength, ataxia, sensation, visual fields, facial strength, language, level of consciousness, and behavior) and was developed to provide a simple, objective assessment of neurologic function that would be combined with radiographic assessment to provide an overall outcome assessment for neuro-oncology participants in clinical trials and in daily practice. The soring scale for Gait consists of score range 0-3, Strength consists of score range 0-2, ataxia (upper extremity) consists of scale range 0-2 and sensation as 0. Higher scores indicate worse neurologic function. The response categories reported are changes from first post-baseline score to worst on-treatment score at any point of treatment.
Time frame: Time from first dose up to 47 days after last dose, or prior to starting any subsequent therapy, or for up to 2 years 7 months, whichever occurred first
Population: The FAS included all the participants who were enrolled in the study and received at least 1 dose of treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Neurologic Assessment in Neuro-Oncology Scale (NANO Scale) | Neurologic stability | 217 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Neurologic Assessment in Neuro-Oncology Scale (NANO Scale) | Not assessed | 0 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Neurologic Assessment in Neuro-Oncology Scale (NANO Scale) | Neurologic progression | 16 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Neurologic Assessment in Neuro-Oncology Scale (NANO Scale) | Non-evaluable | 0 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Neurologic Assessment in Neuro-Oncology Scale (NANO Scale) | Neurologic response | 3 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Neurologic Assessment in Neuro-Oncology Scale (NANO Scale) | Non-evaluable | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Neurologic Assessment in Neuro-Oncology Scale (NANO Scale) | Neurologic response | 4 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Neurologic Assessment in Neuro-Oncology Scale (NANO Scale) | Neurologic stability | 220 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Neurologic Assessment in Neuro-Oncology Scale (NANO Scale) | Neurologic progression | 25 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Number of Participants With Neurologic Assessment in Neuro-Oncology Scale (NANO Scale) | Not assessed | 5 Participants |
Secondary
Objective Response Rate in Cohort 2 (Participants With Brain Metastasis at Baseline)
The ORR is defined as the percentage of participants who have a confirmed CR or confirmed PR, as determined by ICR per RECIST 1.1.
Time frame: From first dose (Day 1) to progression of disease (up to 2 years 7 months)
Population: The FAS included all the participants who were enrolled in the study and received at least 1 dose of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Objective Response Rate in Cohort 2 (Participants With Brain Metastasis at Baseline) | 51.7 Percentage of participants |
Secondary
Second Progression-Free Survival Rate at 12 Months
Second progression-free survival rate is the percentage of participants alive and free from a second progression on next-line treatment at 12 months, estimated by the Kaplan-Meier method. The second progression is defined as the earliest progression event subsequent to the first anti-cancer therapy after the initial progression.
Time frame: At 12 Months
Population: The FAS included all the participants who were enrolled in the study and received at least 1 dose of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Second Progression-Free Survival Rate at 12 Months | 81.1 Percentage of Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Second Progression-Free Survival Rate at 12 Months | 83.1 Percentage of Participants |
Secondary
Site (CNS vs Extracranial vs Both) of Next Progression
Site of next progression (CNS \[CNS RECIST 1.1\] or extracranial \[systemic RECIST 1.1\] in participants who developed isolated CNS progression, received local therapy, and continued on protocol therapy.
Time frame: From the date of the first documented isolated CNS progression to the date of the next documented CNS disease progression (up to 2 years 7 months)
Population: The FAS for isolated CNS progression analyses included participants that received at least 1 dose of treatment who developed isolated CNS progression, per investigator assessment, received local therapy, and continued on protocol therapy.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Site (CNS vs Extracranial vs Both) of Next Progression | CNS | 0 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Site (CNS vs Extracranial vs Both) of Next Progression | Extracranial | 0 Participants |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Site (CNS vs Extracranial vs Both) of Next Progression | Both | 0 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Site (CNS vs Extracranial vs Both) of Next Progression | CNS | 6 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Site (CNS vs Extracranial vs Both) of Next Progression | Extracranial | 2 Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Site (CNS vs Extracranial vs Both) of Next Progression | Both | 4 Participants |
Secondary
St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis
The effect of T-DXd on symptoms, functioning, and HRQoL in HER2+ MBC participants with or without baseline brain metastasis was evaluated. The SGRQ-I is an idiopathic pulmonary fibrosis-specific version of the instrument developed and validated for use among participants with idiopathic pulmonary fibrosis, a type of ILD. The SGRQ-I was used to assess the HRQoL among participants who have been diagnosed with ILD/pneumonitis. It includes 34 of the original SGRQ items determined to be most reliable for assessing the HRQoL of participants with idiopathic pulmonary fibrosis. The instrument yields 3 domain scores (symptoms, activity, and impact) as well as a total score, with scores ranging from 0 to 100. Higher scores indicate greater impairment in HRQoL.
Time frame: From time of ILD/pneumonitis diagnosis (every week) until end of safety follow-up (47 days post last dose) (up to 2 years 7 months)
Population: The safety analysis set- ILD consisted of participants who developed ILD/Pneumonitis. The number analyzed refers to the number of participants included in the analysis at specific time points in each row.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Baseline | 32.1 Score on scale | Standard Deviation 19.31 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 17 | 4.2 Score on scale | Standard Deviation 1.09 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 18 | 4.2 Score on scale | Standard Deviation 1.09 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 19 | 9.1 Score on scale | Standard Deviation 7.02 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 20 | 7.9 Score on scale | Standard Deviation 6.41 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 21 | 7.5 Score on scale | Standard Deviation 5.78 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 22 | 6.7 Score on scale | Standard Deviation 2.44 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 23 | 6.7 Score on scale | Standard Deviation 2.44 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 24 | 6.7 Score on scale | Standard Deviation 2.44 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 25 | 5.6 Score on scale | Standard Deviation 2.56 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 26 | 5.6 Score on scale | Standard Deviation 2.56 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 27 | 5.6 Score on scale | Standard Deviation 2.56 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 28 | 5.6 Score on scale | Standard Deviation 2.56 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 29 | 6.7 Score on scale | Standard Deviation 2.44 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 30 | 4.7 Score on scale | Standard Deviation 1.19 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 31 | 5.6 Score on scale | Standard Deviation 2.56 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 32 | 5.6 Score on scale | Standard Deviation 2.56 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 33 | 6.7 Score on scale | Standard Deviation 2.44 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 34 | 5.5 Score on scale | Standard Deviation 2.62 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 35 | 6.6 Score on scale | Standard Deviation 2.76 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 36 | 6.7 Score on scale | Standard Deviation 2.44 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 37 | 5.4 Score on scale | Standard Deviation 2.45 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 38 | 6.7 Score on scale | Standard Deviation 2.44 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 39 | 5.0 Score on scale | — |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 40 | 5.6 Score on scale | Standard Deviation 2.56 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 41 | 5.6 Score on scale | Standard Deviation 2.56 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 42 | 6.7 Score on scale | Standard Deviation 2.44 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 43 | 5.6 Score on scale | Standard Deviation 2.56 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 44 | 7.4 Score on scale | Standard Deviation 5.54 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 45 | 9.5 Score on scale | — |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 46 | 6.7 Score on scale | Standard Deviation 2.44 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 47 | 6.7 Score on scale | Standard Deviation 2.44 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 48 | 6.7 Score on scale | Standard Deviation 2.44 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 49 | 6.7 Score on scale | Standard Deviation 2.44 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 50 | 9.1 Score on scale | Standard Deviation 0.99 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 51 | 8.2 Score on scale | Standard Deviation 0.32 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 52 | 6.7 Score on scale | Standard Deviation 2.44 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 53 | 6.7 Score on scale | Standard Deviation 2.44 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 54 | 6.7 Score on scale | Standard Deviation 2.44 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 55 | 6.7 Score on scale | Standard Deviation 2.44 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 56 | 7.5 Score on scale | Standard Deviation 3.53 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 57 | 8.4 Score on scale | — |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 58 | 8.4 Score on scale | — |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 59 | 10.0 Score on scale | — |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 60 | 8.4 Score on scale | — |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 61 | 8.4 Score on scale | — |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 62 | 8.4 Score on scale | — |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 63 | 10.0 Score on scale | — |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 64 | 8.4 Score on scale | — |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | End of treatment | 31.1 Score on scale | Standard Deviation 18.65 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Safety Follow-up | 23.4 Score on scale | Standard Deviation 6.38 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 1 | 28.2 Score on scale | Standard Deviation 17.1 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 2 | 23.3 Score on scale | Standard Deviation 22.91 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 3 | 19.5 Score on scale | Standard Deviation 20.1 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 4 | 4.2 Score on scale | Standard Deviation 1.09 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 5 | 8.0 Score on scale | Standard Deviation 6.4 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 6 | 6.7 Score on scale | Standard Deviation 2.39 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 7 | 5.4 Score on scale | Standard Deviation 3.49 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 8 | 3.3 Score on scale | Standard Deviation 1.75 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 9 | 8.0 Score on scale | Standard Deviation 4.29 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 10 | 6.6 Score on scale | Standard Deviation 2.36 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 11 | 8.9 Score on scale | Standard Deviation 1.79 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 12 | 8.4 Score on scale | Standard Deviation 2.73 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 13 | 6.2 Score on scale | Standard Deviation 0.27 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 14 | 5.5 Score on scale | Standard Deviation 2.97 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 15 | 4.2 Score on scale | Standard Deviation 1.09 |
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 16 | 4.2 Score on scale | Standard Deviation 1.09 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 49 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Safety Follow-up | 21.4 Score on scale | Standard Deviation 25.36 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 50 | 6.2 Score on scale | Standard Deviation 3.86 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Baseline | 27.6 Score on scale | Standard Deviation 20.97 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 51 | 10.4 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 8 | 16.9 Score on scale | Standard Deviation 17.04 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 1 | 33.1 Score on scale | Standard Deviation 30.33 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 53 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 12 | 21.8 Score on scale | Standard Deviation 14.4 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 16 | 12.3 Score on scale | Standard Deviation 10.1 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 17 | 12.1 Score on scale | Standard Deviation 15.07 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 54 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 18 | 13.3 Score on scale | Standard Deviation 16.29 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 2 | 21.5 Score on scale | Standard Deviation 14.48 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 19 | 8.7 Score on scale | Standard Deviation 9.07 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 55 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 20 | 6.2 Score on scale | Standard Deviation 3.86 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 9 | 23.3 Score on scale | Standard Deviation 17.2 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 21 | 5.2 Score on scale | Standard Deviation 2.58 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 56 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 22 | 15.4 Score on scale | Standard Deviation 13.24 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 3 | 15.3 Score on scale | Standard Deviation 15.23 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 23 | 9.8 Score on scale | Standard Deviation 9.74 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 57 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 24 | 17.3 Score on scale | Standard Deviation 15.09 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 13 | 20.4 Score on scale | Standard Deviation 17.95 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 25 | 11.0 Score on scale | Standard Deviation 10.9 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 58 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 26 | 10.5 Score on scale | Standard Deviation 10.81 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 4 | 17.8 Score on scale | Standard Deviation 15.49 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 27 | 13.5 Score on scale | Standard Deviation 11.53 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 59 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 28 | 10.7 Score on scale | Standard Deviation 11.13 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 10 | 18.6 Score on scale | Standard Deviation 14.54 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 29 | 16.5 Score on scale | Standard Deviation 16.52 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 60 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 30 | 19.6 Score on scale | Standard Deviation 18.6 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 5 | 15.9 Score on scale | Standard Deviation 15.43 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 31 | 15.9 Score on scale | Standard Deviation 13.98 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 61 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 32 | 11.4 Score on scale | Standard Deviation 10.89 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 15 | 12.9 Score on scale | Standard Deviation 10.49 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 33 | 5.2 Score on scale | Standard Deviation 3.15 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 62 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 34 | 11.9 Score on scale | Standard Deviation 10.36 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 6 | 16.4 Score on scale | Standard Deviation 11.95 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 35 | 11.9 Score on scale | Standard Deviation 10.32 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 63 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 36 | 15.9 Score on scale | Standard Deviation 17.62 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 11 | 20.3 Score on scale | Standard Deviation 14.92 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 37 | 11.5 Score on scale | Standard Deviation 9.72 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 64 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 38 | 11.8 Score on scale | Standard Deviation 10.13 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 65 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 39 | 6.2 Score on scale | Standard Deviation 3.86 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 66 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 40 | 6.2 Score on scale | Standard Deviation 3.86 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 67 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 41 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 68 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 42 | 6.2 Score on scale | Standard Deviation 3.86 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 69 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 43 | 6.2 Score on scale | Standard Deviation 3.86 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 70 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 44 | 6.2 Score on scale | Standard Deviation 3.86 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 71 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 45 | 6.2 Score on scale | Standard Deviation 3.86 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 72 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 46 | 8.9 Score on scale | — |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 7 | 14.8 Score on scale | Standard Deviation 15.73 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 47 | 6.2 Score on scale | Standard Deviation 3.86 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | End of treatment | 18.0 Score on scale | Standard Deviation 19.16 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 48 | 6.2 Score on scale | Standard Deviation 3.86 |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | St. George's Respiratory Questionnaire - Idiopathic (SGRQ-I) Pulmonary Fibrosis Version in Participants With Interstitial Lung Disease (ILD)/Pneumonitis | Total: Week 14 | 8.6 Score on scale | Standard Deviation 7.19 |
Secondary
Survival Rate at 12 Months
Survival rate is the percentage of participants alive at 12 months, estimated by the Kaplan-Meier method.
Time frame: At 12 Months
Population: The FAS included all participants who were enrolled in the study and received at least 1 dose of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Survival Rate at 12 Months | 90.6 Percentage of Participants |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Survival Rate at 12 Months | 90.3 Percentage of Participants |
Secondary
Time to New CNS Lesions in Participants With Brain Metastasis at Baseline (Cohort 2)
The time to new CNS lesions is defined as the time from the date of the first dose of study intervention to the date of documented new CNS lesions by RECIST 1.1 per ICR.
Time frame: From first dose (Day 1) to the date of documented new CNS lesions (up to 2 years 7 months)
Population: The FAS included all participants who were enrolled in the study and received at least 1 dose of treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Time to New CNS Lesions in Participants With Brain Metastasis at Baseline (Cohort 2) | NA Months |
Secondary
Time to Next Progression (CNS or Extracranial) or Death
The time to next progression is defined as the time from the date of the first documented isolated CNS progression to the date of the next documented disease progression (CNS or extracranial) per RECIST 1.1 or death and has been summarized descriptively in participants who have developed isolated CNS progression, receive local therapy, and continue on protocol therapy.
Time frame: From date of first documented isolated CNS progression to the date of the next documented disease progression (up to 2 years 7 months)
Population: The FAS for isolated CNS progression analyses included participants that received at least 1 dose of treatment who developed isolated CNS progression, per investigator assessment, received local therapy, and continued on protocol therapy.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Time to Next Progression (CNS or Extracranial) or Death | 3.7 Months |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Time to Next Progression (CNS or Extracranial) or Death | 0.2 Months |
Secondary
Time to Progression
Time to progression by RECIST 1.1 per ICR is defined as the time from the date of the first dose of study intervention to the date of documented disease progression.
Time frame: From first dose (Day 1) to progression of disease (up to 2 years 7 months)
Population: The FAS included all the participants who were enrolled in the study and received at least 1 dose of treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | Time to Progression | NA Months |
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | Time to Progression | NA Months |