Patterns of Care and Outcomes in Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer

Launched by DAIICHI SANKYO · Jul 28, 2025

Keywords

ClinConnect Summary

This study is focused on understanding how patients with a specific type of breast cancer called triple-negative breast cancer (TNBC) are tested, treated, and how they fare over time. This form of breast cancer is more challenging to treat because it lacks certain markers that many treatments target. The study looks at people whose cancer has come back in a way that cannot be removed by surgery or has spread to other parts of the body. Researchers want to gather real-world information from countries like Canada, the UK, France, and Spain to better understand current care and outcomes outside the United States.

People who may be eligible for this study are adults diagnosed between 2020 and 2024 with this advanced or metastatic form of TNBC, confirmed by specific lab tests showing the cancer lacks certain hormone receptors and HER2 protein. Participants must have medical records available around the time of diagnosis, and they should not have had other recent cancers or been part of other experimental cancer drug trials. Since this is an observational study, participants won’t receive new treatments through the trial but will have their existing medical information reviewed to help researchers learn more about how this cancer is managed and what outcomes patients experience. This information can help improve future care for people with advanced TNBC.

Gender

ALL

Eligibility 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