Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer
Conditions
Keywords
MEDI-573, breast cancer, metastatic, aromatase inhibitor, anti-IGF
Brief summary
Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an aromatase inhibitor (AI) in adult subjects with HR+, HER2-negative MBC.
Detailed description
This is a Phase 1b/2, multicenter, open-label study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an AI in adult subjects with HR+, HER2-negative MBC. This study has 2 phases: a dose-evaluation phase (Phase 1b) and a randomization phase (Phase 2).
Interventions
DRUGMEDI-573
Intravenous infusion of MEDI-573 (10 or 30 or 45 mg/kg) will be administered on Day 1 of each 21-day cycle until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
DRUGAromatase Inhibitor
Aromatase inhibitor of the investigator's choice (letrozole, anastrozole, or exemestane) will be provided orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Histologically-confirmed MBC not deemed amenable to curative surgery or curative radiation therapy * Tumors are positive for ER, PgR, or both * Tumors must be negative for HER2 (by FISH, CISH or IHC) * Female gender and age ≥ 18 years at time of study entry * Postmenopausal * Karnofsky Performance Status ≥ 70 * Life expectancy of ≥ 6 months
Exclusion criteria
* Subjects who received prior chemotherapy, hormonal therapy, immunotherapy or biologic therapy for advanced or metastatic disease with the following exceptions: * Prior adjuvant therapy with an AI and/or tamoxifen is allowed, provided treatment ended at least 2 weeks prior to the first dose of MEDI-573 * Prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed * Extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor, or disease that is considered by the investigator to be rapidly progressing or life threatening (eg, subjects who are intended for chemotherapy) * Active brain metastases with the exception of subject has been treated and are asymptomatic and there has been no evidence of CNS progression for at least 4 weeks of first dose of MEDI-573 * Evidence of ongoing spinal cord compression or leptomeningeal carcinomatosis * Unresolved toxicities from prior therapy with the exception of alopecia that have not resolved to ≤ Grade 1 at the time of starting study treatment * Previous treatment with agents that target the IGF receptor * History of allergy or reaction attributed to compounds of chemical or biologic composition similar to those of MEDI-573 or AI * History of another invasive malignancy within 5 years except for curatively resected nonmelanoma skin cancer or carcinoma in situ of the cervix * Poorly controlled diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1b and Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years) | An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years). |
| Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) | Up to Day 21 of Cycle 1 | The AEs that occurred during Cycle 1 (Days 1 to 21) and were suspected of having a causal relationship to MEDI-573 and were \>= Grade 3 in severity were considered as DLTs. |
| Phase 1b: Number of DLTs | Up to Day 21 of Cycle 1 | The AEs that occurred during Cycle 1 (Days 1 to 21) and were suspected of having a causal relationship to MEDI-573 and were \>= Grade 3 in severity were considered as DLTs. |
| Phase 2: Progression-free Survival (PFS) | From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years) | Progression-free survival (PFS) was defined as the time from the randomization until the first documentation of disease progression or death due to any cause, whichever occurred first. The PFS was censored on the date of the last tumor assessment documenting absence of tumor progression for participants who had no documented progression and were still alive prior to data cut-off, dropout, or the initiation of alternate anticancer treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as \>= 20% increase in the sum of diameters of target lesions and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2: Objective Response Rate (ORR) | From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years) | The ORR was defined as percentage of participants with confirmed complete response or confirmed partial response, where CR was defined as disappearance of all target and non-target lesions and no new lesions and PR was definded as \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. |
| Phase 2: Time to Response | From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years) | Time to response was measured from treatment start to the first documentation of disease response and was evaluated only in participants who achieved objective response (confirmed CR or confirmed PR. The CR was defined as disappearance of all target and non-target lesions and no new lesions and PR was defined as \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. |
| Phase 2: Duration of Response (DR) | From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years) | Duration of response (DR) is measured from the first documentation of disease response to the first documented progressive disease and was evaluated only in participants who achieved objective response (confirmed CR or confirmed PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions and PR was defined as \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. |
| Phase 2: Time to Progression (TTP) | From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years) | Time to progression was measured from treatment start until the first documentation of disease progression. The PD was defined as \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion. |
| Phase 2: Overall Survival (OS) | From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years) | Overall survival (OS) was measured from treatment start until death. |
| Phase 2: Change in Tumor Size | From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years) | Mean change in tumor size is reported. |
| Phase 1b and Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to Day 21 (AUC0-day21) of MEDI-573 for Cycle 1 | Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose) | AUC0-day21 of MEDI-573 for Cycle 1 is reported. |
| Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years) | An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years). |
| Phase 1b and Phase 2: Dose-Normalised Area Under the Serum Concentration-time Curve From Time Zero to Infinity (DN AUC0-inf) of MEDI-573 for Cycle 1 | Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose) | DN AUC0-inf of MEDI-573 for Cycle 1 is reported. |
| Phase 1b and Phase 2: Maximum Observed Serum Concentration (Cmax) of MEDI-573 for Cycle 1 | Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose) | Cmax of MEDI-573 for Cycle 1 is reported. |
| Phase 1b and Phase 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-573 for Cycle 1 | Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose) | Tmax of MEDI-573 for Cycle 1 is reported. |
| Phase 1b and Phase 2: Systemic Clearance (CL) of MEDI-573 for Cycle 1 | Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose) | The CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by AUC(0-infinity). |
| Phase 1b and Phase 2: Terminal Half Life (t1/2) of MEDI-573 for Cycle 1 | Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose) | The elimination half-life (t1/2) is the time measured for the serum concentration of MEDI-573 to decrease by 1 half to its original concentration. |
| Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | Baseline (Cycle1 Day1 pre-dose), end of treatment (EOT), and 60 days post last dose (Approximately 8 years) | The mean concentration profiles of both IGF-I and IGF-II post administration of MEDI-573 in plasma were evaluated during treatment. |
| Phase 1b and Phase 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI-573 | Pre-infusion on Day 1 of each cycle, End of Treatment, Day 30, 60 and 90 post treatment (approximately 8 years) | Participants With Positive ADA to MEDI-573 are reported. |
| Phase 1b and Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI-573 for Cycle 1 | Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose) | AUC0-info of MEDI-573 for Cycle 1 is reported. |
| Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years) | An abnormal vital signs that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years). |
| Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years) | An abnormal ECG findings that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years). |
| Phase 2: Number of Participants With Best Overall Tumor Response | From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years) | Tumor evaluation was based on RECIST v1.1 by CT or MRI scan as: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): \>= 20% increase in the sum of diameters of target lesions and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion; not evaluable (NE): either no or only a subset of lesion measurements are made at an assessment. |
Countries
Belgium, Canada, France, Germany, Hungary, Israel, Poland, Spain, The Bahamas, United Kingdom, United States
Participant flow
Recruitment details
The study was conducted across 10 countries (Belgium, Canada, France, Germany, Hungary, Israel, Spain, Poland, United Kingdom, USA).
Pre-assignment details
A total of 187 participants were screened in the study. Of which, 183 participants were treated with study drugs.
Participants by arm
| Arm | Count |
|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. | 3 |
| MEDI-573 30 mg/kg + AI Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. | 3 |
| MEDI-573 45 mg/kg + AI Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study. | 92 |
| Aromatase Inhibitor Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. | 85 |
| Total | 183 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 2 | 3 | 43 | 36 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 2 |
| Overall Study | Other | 0 | 0 | 13 | 13 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 14 | 11 |
Baseline characteristics
| Characteristic | MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | MEDI-573 30 mg/kg + AI | MEDI-573 45 mg/kg + AI | Aromatase Inhibitor | Total |
|---|---|---|---|---|---|
| Age, Continuous | 66.3 Years STANDARD_DEVIATION 12.3 | 61.0 Years STANDARD_DEVIATION 8.7 | 63.2 Years STANDARD_DEVIATION 10.5 | 63.3 Years STANDARD_DEVIATION 11 | 63.2 Years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 7 Participants | 6 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 3 Participants | 85 Participants | 79 Participants | 170 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 6 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 84 Participants | 82 Participants | 171 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 92 Participants | 85 Participants | 183 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 6 | 3 / 6 | 43 / 184 | 36 / 170 |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 86 / 92 | 79 / 85 |
| serious Total, serious adverse events | 2 / 3 | 0 / 3 | 21 / 92 | 16 / 85 |
Outcome results
Primary
Phase 1b and Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).
Time frame: From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)
Population: Safety population included all participants who received any study therapy and were analyzed per the treatment they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 3 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 2 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 3 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 21 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 90 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 82 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 16 Participants |
Primary
Phase 1b: Number of DLTs
The AEs that occurred during Cycle 1 (Days 1 to 21) and were suspected of having a causal relationship to MEDI-573 and were \>= Grade 3 in severity were considered as DLTs.
Time frame: Up to Day 21 of Cycle 1
Population: Evaluable population included all participants in Phase 1b of the study, who received at least 1 full cycle of MEDI-573 and completed the safety follow-up through the DLT evaluation period (Days 1 to 21 of Cycle 1).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b: Number of DLTs | 0 DLT events |
| MEDI-573 30 mg/kg + AI | Phase 1b: Number of DLTs | 0 DLT events |
| MEDI-573 45 mg/kg + AI | Phase 1b: Number of DLTs | 0 DLT events |
Primary
Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs)
The AEs that occurred during Cycle 1 (Days 1 to 21) and were suspected of having a causal relationship to MEDI-573 and were \>= Grade 3 in severity were considered as DLTs.
Time frame: Up to Day 21 of Cycle 1
Population: Evaluable population included all participants in Phase 1b of the study, who received at least 1 full cycle of MEDI-573 and completed the safety follow-up through the DLT evaluation period (Days 1 to 21 of Cycle 1).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
Primary
Phase 2: Progression-free Survival (PFS)
Progression-free survival (PFS) was defined as the time from the randomization until the first documentation of disease progression or death due to any cause, whichever occurred first. The PFS was censored on the date of the last tumor assessment documenting absence of tumor progression for participants who had no documented progression and were still alive prior to data cut-off, dropout, or the initiation of alternate anticancer treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as \>= 20% increase in the sum of diameters of target lesions and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion.
Time frame: From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)
Population: The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 2: Progression-free Survival (PFS) | 12.65 Months |
| MEDI-573 30 mg/kg + AI | Phase 2: Progression-free Survival (PFS) | 11.33 Months |
p-value: 0.8695% CI: [0.689, 1.429]Log Rank
Secondary
Phase 1b and Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to Day 21 (AUC0-day21) of MEDI-573 for Cycle 1
AUC0-day21 of MEDI-573 for Cycle 1 is reported.
Time frame: Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)
Population: The ITT population was considered for this analysis. Participants who received MEDI-573 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to Day 21 (AUC0-day21) of MEDI-573 for Cycle 1 | 1430 μg·day/mL | Standard Deviation 867 |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to Day 21 (AUC0-day21) of MEDI-573 for Cycle 1 | 4500 μg·day/mL | Standard Deviation 725 |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to Day 21 (AUC0-day21) of MEDI-573 for Cycle 1 | 7990 μg·day/mL | Standard Deviation 1590 |
Secondary
Phase 1b and Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI-573 for Cycle 1
AUC0-info of MEDI-573 for Cycle 1 is reported.
Time frame: Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)
Population: The ITT population was considered for this analysis. Participants who received MEDI-573 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI-573 for Cycle 1 | 1500 μg·day/mL | Standard Deviation 955 |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI-573 for Cycle 1 | 4930 μg·day/mL | Standard Deviation 691 |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI-573 for Cycle 1 | 9570 μg·day/mL | Standard Deviation 2310 |
Secondary
Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II
The mean concentration profiles of both IGF-I and IGF-II post administration of MEDI-573 in plasma were evaluated during treatment.
Time frame: Baseline (Cycle1 Day1 pre-dose), end of treatment (EOT), and 60 days post last dose (Approximately 8 years)
Population: Safety population included all participants who received any study therapy and were analyzed per the treatment they actually received. Participants with free IGF concentration were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | Baseline: Free IGF-I Concentration | 2.57 ng/mL | Standard Deviation 0.712 |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | 60 days post last dose: Free IGF-II Concentration | 1.49 ng/mL | — |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | EOT: Free IGF-I Concentration | 0.724 ng/mL | Standard Deviation 0.421 |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | 60 days post last dose: Free IGF-I Concentration | 1.54 ng/mL | — |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | EOT: Free IGF-II Concentration | 0.625 ng/mL | Standard Deviation 0 |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | Baseline: Free IGF-II Concentration | 3.81 ng/mL | Standard Deviation 1.66 |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | Baseline: Free IGF-I Concentration | 1.25 ng/mL | Standard Deviation 0.635 |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | 60 days post last dose: Free IGF-I Concentration | 1.33 ng/mL | Standard Deviation 0.3 |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | 60 days post last dose: Free IGF-II Concentration | 0.625 ng/mL | Standard Deviation 0 |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | EOT: Free IGF-II Concentration | 0.625 ng/mL | Standard Deviation 0 |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | Baseline: Free IGF-II Concentration | 3.07 ng/mL | Standard Deviation 0.709 |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | EOT: Free IGF-I Concentration | 0.313 ng/mL | Standard Deviation 0 |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | 60 days post last dose: Free IGF-I Concentration | 1.02 ng/mL | Standard Deviation 1.29 |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | Baseline: Free IGF-I Concentration | 3.49 ng/mL | Standard Deviation 4.39 |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | EOT: Free IGF-II Concentration | 0.641 ng/mL | Standard Deviation 0.102 |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | 60 days post last dose: Free IGF-II Concentration | 0.984 ng/mL | Standard Deviation 0.734 |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | Baseline: Free IGF-II Concentration | 3.01 ng/mL | Standard Deviation 1.2 |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | EOT: Free IGF-I Concentration | 0.346 ng/mL | Standard Deviation 0.13 |
| Aromatase Inhibitor | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | 60 days post last dose: Free IGF-I Concentration | 4.62 ng/mL | Standard Deviation 8.52 |
| Aromatase Inhibitor | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | Baseline: Free IGF-I Concentration | 1.89 ng/mL | Standard Deviation 1.24 |
| Aromatase Inhibitor | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | EOT: Free IGF-I Concentration | 2.32 ng/mL | Standard Deviation 3.64 |
| Aromatase Inhibitor | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | Baseline: Free IGF-II Concentration | 3.03 ng/mL | Standard Deviation 1.12 |
| Aromatase Inhibitor | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | EOT: Free IGF-II Concentration | 3.12 ng/mL | Standard Deviation 1.22 |
| Aromatase Inhibitor | Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II | 60 days post last dose: Free IGF-II Concentration | 3.38 ng/mL | Standard Deviation 1.51 |
Secondary
Phase 1b and Phase 2: Dose-Normalised Area Under the Serum Concentration-time Curve From Time Zero to Infinity (DN AUC0-inf) of MEDI-573 for Cycle 1
DN AUC0-inf of MEDI-573 for Cycle 1 is reported.
Time frame: Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)
Population: The ITT population was considered for this analysis. Participants who received MEDI-573 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Dose-Normalised Area Under the Serum Concentration-time Curve From Time Zero to Infinity (DN AUC0-inf) of MEDI-573 for Cycle 1 | 150 day·kg·μg/mL/mg | Standard Deviation 95.5 |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Dose-Normalised Area Under the Serum Concentration-time Curve From Time Zero to Infinity (DN AUC0-inf) of MEDI-573 for Cycle 1 | 164 day·kg·μg/mL/mg | Standard Deviation 23 |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Dose-Normalised Area Under the Serum Concentration-time Curve From Time Zero to Infinity (DN AUC0-inf) of MEDI-573 for Cycle 1 | 213 day·kg·μg/mL/mg | Standard Deviation 51.3 |
Secondary
Phase 1b and Phase 2: Maximum Observed Serum Concentration (Cmax) of MEDI-573 for Cycle 1
Cmax of MEDI-573 for Cycle 1 is reported.
Time frame: Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)
Population: The ITT population was considered for this analysis. Participants who received MEDI-573 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Maximum Observed Serum Concentration (Cmax) of MEDI-573 for Cycle 1 | 269 μg/mL | Standard Deviation 74.1 |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Maximum Observed Serum Concentration (Cmax) of MEDI-573 for Cycle 1 | 624 μg/mL | Standard Deviation 210 |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Maximum Observed Serum Concentration (Cmax) of MEDI-573 for Cycle 1 | 1070 μg/mL | Standard Deviation 253 |
Secondary
Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).
Time frame: From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)
Population: Safety population included all participants who received any study therapy and were analyzed per the treatment they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Platelet count decreased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Neutrophil count increased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood creatine increased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Granulocyte count decreased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Neutrophil count decreased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Monocyte count decreased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood creatinine decreased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Lymphocyte count decreased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood creatinine increased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Leukocytosis | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Gamma-glutamyl transferase increased | 1 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood sodium decreased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Protein total decreased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood uric acid increased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood urea increased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Thrombocytopenia | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Neutropenia | 1 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Gamma-glutamyl transferase decreased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood triglycerides increased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood potassium decreased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood magnesium decreased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Hemoglobin decreased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Lymphopenia | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood lactate dehydrogenase increased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Pancytopenia | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Leukopenia | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | White blood cell count decreased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Neutrophilia | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood glucose increased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Anemia | 1 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Alanine aminotransferase increased | 2 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood bilirubin increased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood bicarbonate decreased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Eosinophilia | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood alkaline phosphatase increased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood albumin increased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood albumin decreased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Aspartate aminotransferase increased | 2 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood chloride decreased | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood bilirubin increased | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Anemia | 1 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Eosinophilia | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Lymphopenia | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Neutropenia | 1 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Pancytopenia | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Thrombocytopenia | 2 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Hemoglobin decreased | 1 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Lymphocyte count decreased | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Platelet count decreased | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | White blood cell count decreased | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood bicarbonate decreased | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood creatine increased | 1 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood creatinine increased | 1 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood sodium decreased | 1 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Gamma-glutamyl transferase increased | 1 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Monocyte count decreased | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Neutrophil count decreased | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Neutrophil count increased | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Alanine aminotransferase increased | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Aspartate aminotransferase increased | 1 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood albumin decreased | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood albumin increased | 1 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood alkaline phosphatase increased | 1 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood chloride decreased | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood creatinine decreased | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood glucose increased | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood lactate dehydrogenase increased | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood magnesium decreased | 1 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood potassium decreased | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood triglycerides increased | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood urea increased | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood uric acid increased | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Gamma-glutamyl transferase decreased | 1 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Protein total decreased | 1 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Leukocytosis | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Neutrophilia | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Leukopenia | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Granulocyte count decreased | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Gamma-glutamyl transferase increased | 9 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Alanine aminotransferase increased | 8 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Aspartate aminotransferase increased | 6 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood bilirubin increased | 0 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Leukocytosis | 0 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood albumin decreased | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood bicarbonate decreased | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood alkaline phosphatase increased | 5 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood albumin increased | 0 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Anemia | 17 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Neutrophilia | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood creatinine decreased | 0 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood creatinine increased | 8 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | White blood cell count decreased | 2 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood glucose increased | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Hemoglobin decreased | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Eosinophilia | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood lactate dehydrogenase increased | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Lymphopenia | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood magnesium decreased | 0 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Granulocyte count decreased | 0 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood potassium decreased | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood sodium decreased | 0 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Leukopenia | 0 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood urea increased | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood uric acid increased | 3 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Thrombocytopenia | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Neutropenia | 3 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Gamma-glutamyl transferase decreased | 0 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood triglycerides increased | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Pancytopenia | 0 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Lymphocyte count decreased | 2 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Monocyte count decreased | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood creatine increased | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Protein total decreased | 0 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Neutrophil count decreased | 2 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Neutrophil count increased | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood chloride decreased | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Platelet count decreased | 4 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood potassium decreased | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Neutrophil count decreased | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Alanine aminotransferase increased | 4 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood bilirubin increased | 1 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Anemia | 10 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood sodium decreased | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Aspartate aminotransferase increased | 4 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Thrombocytopenia | 3 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Lymphocyte count decreased | 1 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Leukopenia | 3 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood albumin decreased | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood bicarbonate decreased | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Leukocytosis | 1 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood albumin increased | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood creatine increased | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Lymphopenia | 2 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood urea increased | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood alkaline phosphatase increased | 5 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Eosinophilia | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | White blood cell count decreased | 1 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Neutropenia | 4 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood uric acid increased | 1 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood chloride decreased | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Monocyte count decreased | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood creatinine increased | 2 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Protein total decreased | 1 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Neutrophilia | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Gamma-glutamyl transferase increased | 4 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood glucose increased | 1 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood triglycerides increased | 2 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Platelet count decreased | 1 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Gamma-glutamyl transferase decreased | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Granulocyte count decreased | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood lactate dehydrogenase increased | 1 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Pancytopenia | 1 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood magnesium decreased | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Neutrophil count increased | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Hemoglobin decreased | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs | Blood creatinine decreased | 1 Participants |
Secondary
Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs
An abnormal ECG findings that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).
Time frame: From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)
Population: Safety population included all participants who received any study therapy and were analyzed per the treatment they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Bradycardia | 1 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Cardiac valve disease | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Sinus tachycardia | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Arrhythmia | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Ventricular extrasystoles | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Supraventricular tachycardia | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Atrioventricular block first degree | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Atrial flutter | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Cardiac failure | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Tachycardia | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Sinus bradycardia | 1 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Palpitation | 1 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Atrial fibrillation | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Angina pectoris | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Atrial flutter | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Arrhythmia | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Atrial fibrillation | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Atrioventricular block first degree | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Ventricular extrasystoles | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Sinus bradycardia | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Angina pectoris | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Cardiac failure | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Sinus tachycardia | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Palpitation | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Supraventricular tachycardia | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Cardiac valve disease | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Tachycardia | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Bradycardia | 0 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Atrioventricular block first degree | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Arrhythmia | 0 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Cardiac valve disease | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Palpitation | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Sinus bradycardia | 2 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Sinus tachycardia | 0 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Supraventricular tachycardia | 0 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Tachycardia | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Angina pectoris | 0 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Atrial fibrillation | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Atrial flutter | 0 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Bradycardia | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Cardiac failure | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Ventricular extrasystoles | 1 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Atrioventricular block first degree | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Angina pectoris | 1 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Tachycardia | 2 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Arrhythmia | 1 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Bradycardia | 1 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Supraventricular tachycardia | 2 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Sinus bradycardia | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Ventricular extrasystoles | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Cardiac failure | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Palpitation | 2 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Cardiac valve disease | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Atrial flutter | 1 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Atrial fibrillation | 2 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs | Sinus tachycardia | 1 Participants |
Secondary
Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs
An abnormal vital signs that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).
Time frame: From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)
Population: Safety population included all participants who received any study therapy and were analyzed per the treatment they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Body temperature increased | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Pyrexia | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Dyspnoea | 2 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Temperature intolerance | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Bradycardia | 1 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Aspiration | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Orthostatic hypotension | 0 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Hypotension | 1 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Palpitations | 1 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Hypertension | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Palpitations | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Aspiration | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Bradycardia | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Pyrexia | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Temperature intolerance | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Body temperature increased | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Dyspnoea | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Hypertension | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Hypotension | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Orthostatic hypotension | 0 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Hypertension | 8 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Bradycardia | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Dyspnoea | 18 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Orthostatic hypotension | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Aspiration | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Pyrexia | 10 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Hypotension | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Temperature intolerance | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Palpitations | 1 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Body temperature increased | 1 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Palpitations | 2 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Body temperature increased | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Aspiration | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Dyspnoea | 14 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Orthostatic hypotension | 0 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Hypertension | 13 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Bradycardia | 1 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Pyrexia | 6 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Temperature intolerance | 1 Participants |
| Aromatase Inhibitor | Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs | Hypotension | 0 Participants |
Secondary
Phase 1b and Phase 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI-573
Participants With Positive ADA to MEDI-573 are reported.
Time frame: Pre-infusion on Day 1 of each cycle, End of Treatment, Day 30, 60 and 90 post treatment (approximately 8 years)
Population: Participants who received MEDI-573 and were analyzed per the treatment they actually received were analyzed for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI-573 | 0 Participants |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI-573 | 0 Participants |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI-573 | 1 Participants |
Secondary
Phase 1b and Phase 2: Systemic Clearance (CL) of MEDI-573 for Cycle 1
The CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by AUC(0-infinity).
Time frame: Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)
Population: The ITT population was considered for this analysis. Participants who received MEDI-573 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Systemic Clearance (CL) of MEDI-573 for Cycle 1 | 8.29 mL/day/kg | Standard Deviation 3.86 |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Systemic Clearance (CL) of MEDI-573 for Cycle 1 | 6.17 mL/day/kg | Standard Deviation 0.889 |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Systemic Clearance (CL) of MEDI-573 for Cycle 1 | 4.96 mL/day/kg | Standard Deviation 1.13 |
Secondary
Phase 1b and Phase 2: Terminal Half Life (t1/2) of MEDI-573 for Cycle 1
The elimination half-life (t1/2) is the time measured for the serum concentration of MEDI-573 to decrease by 1 half to its original concentration.
Time frame: Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)
Population: The ITT population was considered for this analysis. Participants who received MEDI-573 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Terminal Half Life (t1/2) of MEDI-573 for Cycle 1 | 4.38 Day | Standard Deviation 1.07 |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Terminal Half Life (t1/2) of MEDI-573 for Cycle 1 | 5.91 Day | Standard Deviation 2.09 |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Terminal Half Life (t1/2) of MEDI-573 for Cycle 1 | 8.45 Day | Standard Deviation 2.23 |
Secondary
Phase 1b and Phase 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-573 for Cycle 1
Tmax of MEDI-573 for Cycle 1 is reported.
Time frame: Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)
Population: The ITT population was considered for this analysis. Participants who received MEDI-573 were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 1b and Phase 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-573 for Cycle 1 | 0.04 Day |
| MEDI-573 30 mg/kg + AI | Phase 1b and Phase 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-573 for Cycle 1 | 0.07 Day |
| MEDI-573 45 mg/kg + AI | Phase 1b and Phase 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-573 for Cycle 1 | 0.07 Day |
Secondary
Phase 2: Change in Tumor Size
Mean change in tumor size is reported.
Time frame: From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)
Population: The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 2: Change in Tumor Size | -36.2 Centimeters | Standard Deviation 35.8 |
| MEDI-573 30 mg/kg + AI | Phase 2: Change in Tumor Size | -26.8 Centimeters | Standard Deviation 37.2 |
Secondary
Phase 2: Duration of Response (DR)
Duration of response (DR) is measured from the first documentation of disease response to the first documented progressive disease and was evaluated only in participants who achieved objective response (confirmed CR or confirmed PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions and PR was defined as \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions.
Time frame: From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)
Population: The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 2: Duration of Response (DR) | 14.55 Months |
| MEDI-573 30 mg/kg + AI | Phase 2: Duration of Response (DR) | 17.18 Months |
Secondary
Phase 2: Number of Participants With Best Overall Tumor Response
Tumor evaluation was based on RECIST v1.1 by CT or MRI scan as: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): \>= 20% increase in the sum of diameters of target lesions and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion; not evaluable (NE): either no or only a subset of lesion measurements are made at an assessment.
Time frame: From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)
Population: The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 2: Number of Participants With Best Overall Tumor Response | CR | 1 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 2: Number of Participants With Best Overall Tumor Response | PD | 15 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 2: Number of Participants With Best Overall Tumor Response | PR | 23 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 2: Number of Participants With Best Overall Tumor Response | NE | 2 Participants |
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 2: Number of Participants With Best Overall Tumor Response | SD | 48 Participants |
| MEDI-573 30 mg/kg + AI | Phase 2: Number of Participants With Best Overall Tumor Response | NE | 4 Participants |
| MEDI-573 30 mg/kg + AI | Phase 2: Number of Participants With Best Overall Tumor Response | PR | 21 Participants |
| MEDI-573 30 mg/kg + AI | Phase 2: Number of Participants With Best Overall Tumor Response | SD | 46 Participants |
| MEDI-573 30 mg/kg + AI | Phase 2: Number of Participants With Best Overall Tumor Response | PD | 12 Participants |
| MEDI-573 30 mg/kg + AI | Phase 2: Number of Participants With Best Overall Tumor Response | CR | 2 Participants |
Secondary
Phase 2: Objective Response Rate (ORR)
The ORR was defined as percentage of participants with confirmed complete response or confirmed partial response, where CR was defined as disappearance of all target and non-target lesions and no new lesions and PR was definded as \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions.
Time frame: From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)
Population: The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 2: Objective Response Rate (ORR) | 27.0 Percentage of participants |
| MEDI-573 30 mg/kg + AI | Phase 2: Objective Response Rate (ORR) | 27.1 Percentage of participants |
Secondary
Phase 2: Overall Survival (OS)
Overall survival (OS) was measured from treatment start until death.
Time frame: From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)
Population: The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 2: Overall Survival (OS) | 39.39 Months |
| MEDI-573 30 mg/kg + AI | Phase 2: Overall Survival (OS) | 38.34 Months |
Secondary
Phase 2: Time to Progression (TTP)
Time to progression was measured from treatment start until the first documentation of disease progression. The PD was defined as \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion.
Time frame: From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)
Population: The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 2: Time to Progression (TTP) | 14.39 Months |
| MEDI-573 30 mg/kg + AI | Phase 2: Time to Progression (TTP) | 11.33 Months |
Secondary
Phase 2: Time to Response
Time to response was measured from treatment start to the first documentation of disease response and was evaluated only in participants who achieved objective response (confirmed CR or confirmed PR. The CR was defined as disappearance of all target and non-target lesions and no new lesions and PR was defined as \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions.
Time frame: From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)
Population: The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MEDI-573 10 mg/kg + Aromatase Inhibitor (AI) | Phase 2: Time to Response | 4.22 Months |
| MEDI-573 30 mg/kg + AI | Phase 2: Time to Response | 3.98 Months |