Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No drug | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Advanced/metastatic TNBC
- description
- 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.
- interventionNames
- Drug: No drug
Primary outcomes (6)
- measure
- Treatment sequencing before the diagnosis of advanced, metastatic TNBC (i.e., all treatments received for early TNBC if initially diagnosed with earlier-stage disease)
- timeFrame
- From date of initial diagnosis of early TNBC (if applicable) until diagnosis date of advanced, metastatic TNBC, up to approximately 15 months
- description
- Treatment sequencing Includes broad categories for surgery, radiotherapy, adjuvant and neoadjuvant chemotherapy, immunotherapy, and start and stop dates of systemic therapy.
- measure
- Treatment sequencing on or after the diagnosis date for advanced, metastatic TNBC
- timeFrame
- From date of initial diagnosis of advanced, metastatic TNBC until end of follow-up, up to approximately 15 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available