Patterns of Care and Outcomes in Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer
- Registration Number
- NCT07092254
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
This transnational noninterventional study aims to gather real-world evidence on locally recurrent inoperable (hereafter referred to as advanced) or metastatic TNBC (a/m TNBC) biomarker testing, treatment patterns by line of therapy, and outcomes to contextualize findings of TROPION-Breast02 and TROPION-Breast05 in selected settings outside the United States (US), including Canada, the United Kingdom (UK), France, and Spain.
- Detailed Description
This study will document cancer characteristics, real-world cancer treatment patterns, clinical outcomes, and clinical events of interest in patients with locally recurrent inoperable or metastatic triple-negative breast cancer. No study or investigational drug will be administered in this non-interventional study; however, a retrospective review of medical records will be conducted.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 760
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Advanced/metastatic TNBC No drug Adult patients who received a diagnosis of HR-negative and HER2-negative advanced/ metastatic TNBC any time from 1 January 2020 to 31 March 2024.
- Primary Outcome Measures
Name Time Method Real-world disease-free interval (rwDFI) From the completion of treatment with curative intent (either date of breast tumor surgery or date of last dose of systemic therapy (whichever occurred last) and the first local or distant disease recurrence date, up to approximately 15 months Real-world disease-free interval (rwDFI) is assessed from the completion of treatment with curative intent (either date of primary breast tumor surgery or date of last dose of systemic anticancer therapy \[not including endocrine therapy\], whichever occurred last) and the first documented local or distant disease recurrence date
Clinician-defined real-world progression-free survival (rwPFS) From the start of each line of therapy until end of follow up, up to approximately 15 months Clinician-defined rwPFS is assessed from the index date and from the start of each line of therapy.
Overall survival From the start of each line of therapy until end of follow-up, up to approximately 15 months OS is assessed from the index date and from the start of each line of therapy.
Treatment sequencing before the diagnosis of advanced, metastatic TNBC (i.e., all treatments received for early TNBC if initially diagnosed with earlier-stage disease) From date of initial diagnosis of early TNBC (if applicable) until diagnosis date of advanced, metastatic TNBC, up to approximately 15 months Treatment sequencing Includes broad categories for surgery, radiotherapy, adjuvant and neoadjuvant chemotherapy, immunotherapy, and start and stop dates of systemic therapy.
Treatment sequencing on or after the diagnosis date for advanced, metastatic TNBC From date of initial diagnosis of advanced, metastatic TNBC until end of follow-up, up to approximately 15 months Treatment sequencing Includes broad categories for surgery, radiotherapy, adjuvant and neoadjuvant chemotherapy, immunotherapy, and start and stop dates of systemic therapy.
Occurrence of clinical events of interest From the start of each line of therapy until end of follow-up, up to approximately 15 months The occurrence of the following clinical events of interest will be assessed during each therapy line: Oral mucositis/stomatitis, Interstitial lung disease/pneumonitis, OSE, Diarrhea, Nausea/vomiting, Anemia, Neutropenia, Febrile neutropenia, Leukopenia, Lymphopenia, Thrombocytopenia.
- Secondary Outcome Measures
Name Time Method