Phase I/II Study of Neoadjuvant Lapatinib in Breast Cancer
Status:
Completed
Trial end date:
2013-07-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC