Phase I/II Study of Neoadjuvant Lapatinib in Breast Cancer

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving trastuzumab after surgery may kill any tumor cells that remain after surgery. PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of docetaxel and lapatinib when given with or without combination chemotherapy and to see how well they work in treating women with locally advanced, inflammatory, or resectable breast cancer.

Timeline

Start

2007-02

Primary completion

2013-07

Completion

2013-07

Publications

• Results Bonnefoi H, Jacot W, Saghatchian M, Moldovan C, Venat-Bouvet L, Zaman K, Matos E, Petit T, Bodmer A, Quenel-Tueux N, Chakiba C, Vuylsteke P, Jerusalem G, Brain E, Tredan O, Messina CG, Slaets L, Cameron D. Neoadjuvant treatment with docetaxel plus lapatinib, trastuzumab, or both followed by an anthracycline-based chemotherapy in HER2-positive breast cancer: results of the randomised phase II EORTC 10054 study. Ann Oncol. 2015 Feb;26(2):325-32. doi: 10.1093/annonc/mdu551. Epub 2014 Dec 1.
• Results Bonnefoi H, Zaman K, Debled M, Fiche M, Fournier M, Nobahar M, Pierga JY, Koch KM, Bartlett J, Zimmer A, Marreaud S, Bogaerts J, Cameron D. An European Organisation for Research and Treatment of Cancer phase I study of lapatinib and docetaxel as neoadjuvant treatment for human epidermal growth factor receptor 2 (HER2) positive locally-advanced/inflammatory or large operable breast cancer. Eur J Cancer. 2013 Jan;49(2):281-9. doi: 10.1016/j.ejca.2012.08.006. Epub 2012 Sep 18.

Drugs

Indications