Dasatinib In Combination With Trastuzumab And Paclitaxel In First Line Treatment Of Her2-Positive MBC Patients

Summary

This is a single-arm, open-label, phase I/II study. In the phase I, patients with Human Epidermal Growth Factor Receptor 2 (HER2) positive MBC will be treated with paclitaxel, trastuzumab and increasing doses of dasatinib to determine the Maximum Tolerated Dose (MTD), Dose Limiting Toxicity (DLT) and Recommended Phase II Dose (RPD) of the combination. Once the RPD has been identified, 48 patients will be treated at that dose to evaluate the efficacy and safety of the combination in the phase II.

Timeline

Start

2011-07

Primary completion

2013-12

Completion

2019-03-15

Publications

• Results Ocana A, Gil-Martin M, Antolin S, Atienza M, Montano A, Ribelles N, Urruticoechea A, Falcon A, Pernas S, Orlando J, Montero JC, Escudero MJ, Benito S, Caballero R, Carrasco E, Rojo F, Pandiella A, Ruiz-Borrego M. Efficacy and safety of dasatinib with trastuzumab and paclitaxel in first line HER2-positive metastatic breast cancer: results from the phase II GEICAM/2010-04 study. Breast Cancer Res Treat. 2019 Apr;174(3):693-701. doi: 10.1007/s10549-018-05100-z. Epub 2019 Jan 3.
• Results Ocana A, Gil-Martin M, Martin M, Rojo F, Antolin S, Guerrero A, Trigo JM, Munoz M, Pandiella A, Diego NG, Bezares S, Caballero R, Carrasco E, Urruticoechea A. A phase I study of the SRC kinase inhibitor dasatinib with trastuzumab and paclitaxel as first line therapy for patients with HER2-overexpressing advanced breast cancer. GEICAM/2010-04 study. Oncotarget. 2017 Apr 14;8(42):73144-73153. doi: 10.18632/oncotarget.17113. eCollection 2017 Sep 22.

Drugs

Indications