drugset / Trial / NCT02712723
Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine if ribociclib in combination with letrozole for 24 weeks as neoadjuvant endocrine therapy increases the proportion of women with Pre-operative Endocrine Prognostic Index (PEPI) score of 0 at surgery compared to patients treated with letrozole alone therefore allowing more patients excellent outcomes without chemotherapy.
Timeline
- Start
- 2016-02
- Primary completion
- 2018-08-27
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Letrozole | Other / unclassified | 2.5 mg | Oral |
| Subject | Ribociclib | Small molecule | 400 mg | Oral |
| Subject | Ribociclib | Small molecule | 600 mg | Oral |