drugset / Trial / NCT03322215
HR+/HER2- Advanced Breast Cancer and Endocrine Resistance
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, 2-arm, open-label, multicenter, international phase II trial. A total of 196 patients will be included. The study will include patients with metastatic Hormone Receptor positive / Human Epidermal Growth Factor Receptor (HER2) negative breast cancer with progressive disease after endocrine treatment. Patients will be randomized (1:1) between two treatment arms: A. palbociclib + fulvestrant and b. capecitabine.
Timeline
- Start
- 2017-10-24
- Primary completion
- 2021-04-30
- Completion
- 2023-10-31
Outcome
Outcome not reported
Stopped (Enrollment): “Slow accrual”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 500 mg/m2 | Oral |
| Comparator | Capecitabine | Small molecule | 1250 mg/m2 | Oral |
| Subject | Fulvestrant | Small molecule | 500 mg | Intramuscular |
| Subject | Palbociclib | Small molecule | 75 mg | Oral |
| Subject | Palbociclib | Small molecule | 125 mg | Oral |