drugset / Trial / NCT03671330
Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer.
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This was a randomized, double-blind, placebo-controlled study conducted in Chinese women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, plus an open-label, single-arm pharmacokinetic (PK) subset in postmenopausal Chinese women with HR+, HER2- advanced breast cancer.
Timeline
- Start
- 2018-08-29
- Primary completion
- 2022-04-25
- Completion
- 2025-05-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ribociclib | Small molecule | 600 mg | Oral |
| Background | Anastrozole | Other / unclassified | 1 mg | Oral |
| Background | Goserelin | Other / unclassified | 3.6 mg | Subcutaneous |
| Background | Letrozole | Other / unclassified | 2.5 mg | Oral |