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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No drug | Drug | No study drug will be administered in this non-interventional study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment sequencing before the diagnosis of advanced, metastatic TNBC (i.e., all treatments received for early TNBC if initially diagnosed with earlier-stage disease) | Treatment sequencing Includes broad categories for surgery, radiotherapy, adjuvant and neoadjuvant chemotherapy, immunotherapy, and start and stop dates of systemic therapy. | From date of initial diagnosis of early TNBC (if applicable) until diagnosis date of advanced, metastatic TNBC, up to approximately 15 months |
| Treatment sequencing on or after the diagnosis date for advanced, metastatic TNBC | Treatment sequencing Includes broad categories for surgery, radiotherapy, adjuvant and neoadjuvant chemotherapy, immunotherapy, and start and stop dates of systemic therapy. | From date of initial diagnosis of advanced, metastatic TNBC until end of follow-up, up to approximately 15 months |
| Real-world disease-free interval (rwDFI) | 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 | 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 |
| Clinician-defined real-world progression-free survival (rwPFS) | Clinician-defined rwPFS is assessed from the index date and from the start of each line of therapy. | From the start of each line of therapy until end of follow up, up to approximately 15 months |
| Overall survival |
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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
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:
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The study population will consist of adult patients residing in Canada, France, Spain, and the United Kingdom who received a diagnosis of hormone receptor (HR)-negative and HER2-negative advanced/metastatic TNBC any time from 1 January 2020 to 31 March 2024.
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| Name | Affiliation | Role |
|---|---|---|
| Director | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Basking Ridge | New Jersey | 07920 | United States |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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OS is assessed from the index date and from the start of each line of therapy.
| From the start of each line of therapy until end of follow-up, up to approximately 15 months |
| Occurrence of clinical events of interest | 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. | From the start of each line of therapy until end of follow-up, up to approximately 15 months |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |