NCT06975371Completed
Real-World Outcomes of Patients With Metastatic Breast Cancer After Treatment With First-Line ET+CDK4/6i
Real-World Outcomes of Patients With HR-Positive HER2-Negative Metastatic Breast Cancer After Treatment With First-Line ET+CDK4/6i in the United States
Source: ClinicalTrials.gov · Last updated 7 Oct 2025
Brief summary (registry, in English)
This study aims to assess the treatment patterns and real-world outcomes of HR+/HER- metastatic breast cancer patients who have progressed on 1L ET + CDK4/6i and started a second line (2L) treatment within a real-world cohort in the United States Flatiron Health Database.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1415 (actual)
- First submitted
- 9 May 2025
- Start date
- 14 Apr 2025
- Primary completion date
- 8 May 2025
- Lead sponsor
- Daiichi Sankyo
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06975371
What you commit to
- Study type: Observational
- Participants enrolled: 1415
- From 14 Apr 2025 to the primary completion date, 8 May 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.
Prior treatment
- A record of estrogen receptor 1 (ESR1), phosphatidylinositol4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA), V-akt murine thymoma viral oncogene homolog (AKT1), phosphatase and tensin homolog (PTEN), or germline breast cancer gene (gBRCA) alteration/mutation prior to or within 30 days after index treatment date
Who the study is looking for
- Patients with evidence of Stage IV or recurrent mBC with a metastatic diagnosis date on or after January 1, 2017
- Aged ≥18 years at mBC diagnosis date
- Received 1L ET + CDK 4/6i, with no other systemic agents, in the metastatic setting
- Had evidence of a rwP event during 1L ET + CDK 4/6i
- Evidence of a subsequent LOT following 1L ET + CDK 4/6i (start date of subsequent LOT = index treatment date)
- A record of HR+ status in the closest estrogen receptor (ER) or progesterone receptor (PR) test result occurring prior to or within 30 days after the index treatment date
- A record of HER2- status in the closest HER2 test result recorded prior to or on the index treatment date
- Index treatment date occurring at least 90 days prior to end of study period (30Sep2024)
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 |
|---|---|---|---|
| Flatiron Health, Inc Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.