Primary endpoint
Progression-free survival.
phase 2 · Recruiting
Phase 2 study of BPC-101 after prior CDK4/6 inhibition
Randomized Phase 2 evaluating BPC-101 versus investigator's choice in patients with HR+/HER2- metastatic breast cancer who progressed on a prior CDK4/6 inhibitor plus endocrine therapy.
Investigational candidate. BPC-101 has not been approved by any regulatory authority.
Enrollment
Patient participation.
Enrolled 180
Target 240
Sites 8
75% of target enrollment reached.
Design
Trial endpoints.
Secondary endpoints
- Overall response rate
- Clinical benefit rate
- Safety
Eligibility
Adults with HR+/HER2- metastatic breast cancer with progression on a CDK4/6 inhibitor and endocrine therapy.
Timeline
- Started
- April 1, 2024
Sites
8 sites for NCT-BPC101-201.
- Cambridge, United States
Cambridge Research Center
245 Binney Street, Cambridge, MA 02142
- Boston, United States
Mass General Cancer Center
55 Fruit Street, Boston, MA 02114
- New York, United States
Memorial Research Hospital
1275 York Avenue, New York, NY 10065
- Houston, United States
Texas Cancer Institute
1515 Holcombe Boulevard, Houston, TX 77030
- Chicago, United States
Midwest Oncology Group
676 North Saint Clair Street, Chicago, IL 60611
- Los Angeles, United States
West Coast Cancer Center
200 UCLA Medical Plaza, Los Angeles, CA 90095
- London, United Kingdom
London Cancer Institute
250 Euston Road, London NW1 2PG
- Madrid, Spain
Madrid Clinical Network
Calle de Alfonso XII 64, 28014 Madrid