drugset / Trial / NCT02057133
A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study evaluates the safety of abemaciclib in combination therapies (letrozole, anastrozole, tamoxifen, exemestane, exemestane plus everolimus, trastuzumab, LY3023414 plus fulvestrant, pertuzumab plus trastuzumab with loperamide, or ongoing endocrine therapy) for breast cancer that has spread to other parts of the body.
Timeline
- Start
- 2014-03-10
- Primary completion
- 2021-03-15
- Completion
- 2026-12
Publications
- Tolaney SM, Beeram M, Beck JT, Conlin A, Dees EC, Puhalla SL, Rexer BN, Burris HA, Jhaveri K, Helsten T, Becerra C, Kalinsky K, Moore KN, Manuel AM, Lithio A, Price GL, Chapman SC, Litchfield LM, Goetz MP. Abemaciclib in Combination With Endocrine Therapy for Patients With Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer: A Phase 1b Study. Front Oncol. 2022 Feb 10;11:810023. doi: 10.3389/fonc.2021.810023. eCollection 2021.
- Gelbert LM, Cai S, Lin X, Sanchez-Martinez C, Del Prado M, Lallena MJ, Torres R, Ajamie RT, Wishart GN, Flack RS, Neubauer BL, Young J, Chan EM, Iversen P, Cronier D, Kreklau E, de Dios A. Preclinical characterization of the CDK4/6 inhibitor LY2835219: in-vivo cell cycle-dependent/independent anti-tumor activities alone/in combination with gemcitabine. Invest New Drugs. 2014 Oct;32(5):825-37. doi: 10.1007/s10637-014-0120-7. Epub 2014 Jun 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | 200 mg | Oral |
| Subject | Anastrozole | Other / unclassified | — | Oral |
| Subject | Everolimus | Small molecule | — | Oral |
| Subject | Exemestane | Small molecule | — | Oral |
| Subject | Fulvestrant | Small molecule | — | Intramuscular |
| Subject | Letrozole | Other / unclassified | — | Oral |
| Subject | Pertuzumab | Monoclonal antibody | — | Intravenous |
| Subject | Samotolisib | Small molecule | — | Oral |
| Subject | Tamoxifen | Small molecule | — | Oral |
| Subject | Trastuzumab | Monoclonal antibody | — | Intravenous |
| Background | Loperamide | Small molecule | — | Oral |