Patterns of Care and Outcomes in Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer in Selected Ex-US Countries
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Daiichi Sankyo
- Enrollment
- 760
- Locations
- 1
- Primary Endpoint
- Real-world disease-free interval (rwDFI)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients meeting the following criteria will be included in the study:
- •Histologically or cytologically documented diagnosis of HR-negative and HER2-negative locally recurrent inoperable TNBC (i.e., cannot be treated with curative intent) or advanced/metastatic TNBC from 1 January 2020 to 31 March 2024
- •Negative for estrogen receptor with < 1% of tumor cells positive for estrogen receptor (ER) on immunohistochemistry (IHC)
- •Negative for progesterone receptor with < 1% of tumor cells positive for progesterone receptor on IHC
- •Negative for HER2 with 0 or 1+ intensity on IHC or 2+ intensity on IHC and negative by in situ hybridization per the American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) HER2 guideline
- •The test documented closest to the diagnosis date should be used as the reference
- •Aged at least 18 years upon diagnosis of advanced/metastatic TNBC
- •Known vital status (alive or deceased) as of last available follow-up date documented within the medical record
- •Patients meeting any of the following
Exclusion Criteria
- •will not be eligible for the study:
- •Diagnosis of other prior primary cancers or malignancies (except nonmelanoma skin cancer) unless curatively treated with no evidence of disease for at least 3 years before diagnosis of advanced/metastatic TNBC
- •Ever received treatment as part of any clinical trial of an investigational product for cancer
- •No available medical record entry in the 90 days before or after diagnosis of advanced/metastatic TNBC
Arms & Interventions
Advanced/metastatic TNBC
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.
Intervention: No drug (Drug)
Outcomes
Primary Outcomes
Real-world disease-free interval (rwDFI)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
No secondary outcomes reported