Unresectable Triple-negative Breast Cancer, Metastatic Triple-negative Breast Cancer
Conditions
Keywords
Unresectable triple-negative breast cancer, Metastatic triple-negative breast cancer, Dato-DXd
Brief summary
There are no real-world data available on the effectiveness and safety of Dato-DXd in adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. This NIS will investigate the effectiveness of Dato-DXd, the demographic and clinical characteristics of the patients, and treatment patterns.
Detailed description
This is a multi-center, multi-country, prospective, NIS that will collect real-world clinical data on effectiveness, safety and patient reported tolerability data on oral mucositis/stomatitis and ocular surface events by using linguistically validated diaries from adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. In addition, data on quality of life will be collected using validated patient reported outcomes (EQ5D-5L, EQ-VAS).
Interventions
DRUGDato-DXd
This is a non-interventional study and no drug was administered.
Sponsors
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Age ≥18 years at the time of screening * Histologically or cytologically documented locally recurrent inoperable or metastatic TNBC defined as: * Negative for ER * Negative for progesterone receptor * Negative for HER2 with 0 or 1+ intensity on IHC or 2+ intensity on IHC and negative by in situ hybridization per the ASCO-CAP HER2 guideline * Patients must not be a candidate for PD-1/PD-L1 inhibitor therapy, defined as either the tumor was PD-L1 negative (Combine Positive Score (CPS \< 10), or it was PD-L1 positive (CPS ≥ 10 ) and: have relapsed after prior PD-1/PD-L1 inhibitor therapy for early-stage breast cancer or patient was not eligible for IO therapy due to comorbidities precluding PD-1/PD-L1 inhibitor therapy * Patients had not received prior chemotherapy or other systemic anti-cancer therapy for unresectable or metastatic breast cancer * Decision to newly initiate therapy Dato-DXd according to the physician's choice per SmPC. If the patient received just one dose of Dato-DXd already, the patient can still be included retrospectively * Written and signed Informed Consent (ICF) to participate in the study Key
Exclusion criteria
* Pregnancy or breastfeeding * Patients who at time of data collection for this study are participating in an interventional study regardless of whether the study is double blind or open label. Patients that have participated in an interventional study which is completed but remain blinded are also excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real-world Time to Next Treatment (rwTTNT1) | From index date to time up to approximately 50 months | rwTTNT1 is defined as the length of time from index date to the date the patient received an administration of their next systemic treatment regimen or to their date of death if the patient died before initiation of next systemic treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Patterns of Neoadjuvant and Adjuvant Therapies | From index date up to approximately 50 months | — |
| Real-world Time to Next Treatment 2 (rwTTNT2) | From index date up to approximately 50 months | rwTTNT2 is defined as the time from the start of Dato-DXd administration (1L) to the start of the second subsequent therapy (3L) or death. |
| Real-world Time to Permanent Treatment Discontinuation of the Index Treatment (rwTTD1) | From index date up to approximately 50 months | rwTTD1 is defined as the time between start of Dato-DXd administration and last administration or death. |
| Reasons for rwTTNT1 and rwTNT2 Event | From index date up to approximately 50 months | rwTTNT1 and rwTNT2 are defined as the number of participants categorized according to the reason for rwTTNT1 or rwTTNT2 event. Reasons may include disease progression, adverse events, death, or others. |
| Real-world Overall Survival (rwOS) | From index date up to approximately 50 months | rwOS is defined as time from index date to date of death from any cause. |
| Number of Participants Reporting Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), and Adverse Events of Special Interest (AESIs) | From index date up to approximately 50 months | — |
| Prophylactic and Reactive Treatments Used for AESI Management | From index date up to approximately 50 months | AESI management is defined as the clinical management of physician-reported adverse events of special interest (AESIs), including prophylactic and reactive interventions. Data collected may include treatment name, dose, frequency, and duration of use. |
Contacts
CONTACTDaiichi Sankyo Contact for Clinical Trial Information
Outcome results
None listed