drugset / Trial / NCT02917005
PalbocIclib in PreMenopausal Women With ER Positive/HER-2 Negative MetAstatic Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open label, randomized, multicenter, international phase II study for premenopausal patients with hormone receptor positive, HER2 negative metastatic or locally advanced breast cancer. Patients will be randomized to receive either palbociclib + exemestane + OFS (Arm 1) or exemestane +OFS (Arm 2). Treatment will be continued until disease progression, unacceptable toxicities, or withdrawal of consent.
Timeline
- Start
- 2019-05-07
- Primary completion
- 2021-12
- Completion
- 2023-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Palbociclib | Small molecule | 125 mg | Oral |
| Background | Exemestane | Small molecule | 25 mg | Oral |
| Background | Goserelin | Other / unclassified | 3.6 mg | Subcutaneous |