drugset / Trial / NCT02630693
Two Different Schedules of Palbociclib + Second Line Endocrine Therapy in Estrogen Receptor Positive, HER2 Neg Advanced/Metastatic Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine if the combination of endocrine therapy and Palbociclib at a daily dose of 100 mg will result in a better response to therapy with fewer dose interruptions than the proposed dosing regimen of 125 mg daily for 21 days out of a 28 day cycle in combination with endocrine therapy.
Timeline
- Start
- 2016-04-08
- Primary completion
- 2018-08-15
- Completion
- 2023-11-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Palbociclib | Small molecule | 100 mg | Oral |
| Comparator | Palbociclib | Small molecule | 125 mg | Oral |
| Comparator | Fulvestrant | Small molecule | — | — |
| Comparator | Tamoxifen | Small molecule | — | — |