Patterns of Care and Outcomes in Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

No drug: No study drug will be administered in this non-interventional study.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.
• 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.
• 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.

Trial sites (1)

More Daiichi Sankyo trials in the USA

Other trials for the same condition