NCT07092254Active, not recruiting
Patterns of Care and Outcomes in Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer
Patterns of Care and Outcomes in Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer in Selected Ex-US Countries
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 760 (estimated)
- First submitted
- 18 Jul 2025
- Start date
- Sept 2025
- Primary completion date
- Nov 2025
- Lead sponsor
- Daiichi Sankyo
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07092254
What you commit to
- Study type: Observational
- Planned participants: 760
- From Sept 2025 to the primary completion date, Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.