drugset / Trial / NCT03081234
Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- Intermediate Risk Early Breast Cancer
RandomizedParallel-groupTriple-blindTreatment
Summary
This is an international, multi-center, randomized, double-blinded, placebo-controlled clinical study evaluating the efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, intermediate risk breast cancer.
Timeline
- Start
- 2018-03-31
- Primary completion
- 2025-11-17
- Completion
- 2025-11-17
Publications
- Results Hudis CA, Barlow WE, Costantino JP, Gray RJ, Pritchard KI, Chapman JA, Sparano JA, Hunsberger S, Enos RA, Gelber RD, Zujewski JA. Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: the STEEP system. J Clin Oncol. 2007 May 20;25(15):2127-32. doi: 10.1200/JCO.2006.10.3523.
- Results Hortobagyi GN, Connolly JL, D'Orsi CJ, et al (2017). Breast. From AJCC Cancer Staging Manual 8th ed. By Amin MB, Edge S, Greene FL, et al. Springer
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ribociclib | Small molecule | 600 mg | — |
| Background | Anastrozole | Other / unclassified | 1 mg | — |
| Background | Exemestane | Small molecule | 25 mg | — |
| Background | Letrozole | Other / unclassified | 2.5 mg | — |
| Background | Tamoxifen | Small molecule | 20 mg | — |