drugset / Trial / NCT03078751
Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This was an open label, multi-center protocol for U.S. patients enrolled in the study of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, high risk early breast cancer
Timeline
- Start
- 2017-06-20
- Primary completion
- 2020-03-09
- Completion
- 2020-03-09
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 | Oral |
| Background | Anastrozole | Other / unclassified | 1 mg | Oral |
| Background | Exemestane | Small molecule | 25 mg | Oral |
| Background | Letrozole | Other / unclassified | 2.5 mg | Oral |
| Background | Tamoxifen | Small molecule | 20 mg | Oral |