drugset / Trial / NCT03555877
Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, prospective, randomized, open-label, controlled phase II study to test the addition of the CDK4/6 inhibitor ribociclib to anti-hormonal treatment as maintenance therapy in patients with disease control (at least stable disease) after 1st line chemotherapy.
Timeline
- Start
- 2018-03-15
- Primary completion
- 2022-07-21
- Completion
- 2022-07-21
Publications
- Background Gligorov J, Doval D, Bines J, Alba E, Cortes P, Pierga JY, Gupta V, Costa R, Srock S, de Ducla S, Freudensprung U, Mustacchi G. Maintenance capecitabine and bevacizumab versus bevacizumab alone after initial first-line bevacizumab and docetaxel for patients with HER2-negative metastatic breast cancer (IMELDA): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014 Nov;15(12):1351-60. doi: 10.1016/S1470-2045(14)70444-9. Epub 2014 Sep 28.
- Decker T, Ludtke-Heckenkamp K, Melnichuk L, Hirmas N, Lubbe K, Zahn MO, Schmidt M, Denkert C, Lorenz R, Muller V, Zahm DM, Mundhenke C, Bauer S, Thill M, Seropian P, Filmann N, Loibl S. Anti-hormonal maintenance treatment with the CDK4/6 inhibitor ribociclib after 1st line chemotherapy in hormone receptor positive / HER2 negative metastatic breast cancer: A phase II trial (AMICA). Breast. 2023 Dec;72:103575. doi: 10.1016/j.breast.2023.08.007. Epub 2023 Sep 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ribociclib | Small molecule | 600 mg | Oral |
| Background | Anastrozole | Other / unclassified | 1 mg | — |
| Background | Exemestane | Small molecule | 25 mg | — |
| Background | Fulvestrant | Small molecule | 500 mg | — |
| Background | Letrozole | Other / unclassified | 2.5 mg | — |