Patterns of Care and Outcomes in Locally Recurrent Inoperable or Metastatic Triple-Negative Breas… (NCT07092254) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Patterns of Care and Outcomes in Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer
United States760 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 di…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
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
3
Real-world disease-free interval (rwDFI)
Timeframe: 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