Phase II Safety Study of Docetaxel and Carboplatin in Combination With Trastuzumab and Lapatinib in Early Breast Cancer

NCT00820872 Phase 2 COMPLETED Results posted

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel together with carboplatin, trastuzumab, and lapatinib may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving docetaxel together with carboplatin, trastuzumab, and lapatinib in treating patients with early stage breast cancer.

Details

Lead sponsor	Alliance for Clinical Trials in Oncology
Phase	Phase 2
Status	COMPLETED
Enrolment	30
Start date	2009-02
Completion	2019-08-15

Conditions

• Breast Cancer

Interventions

• trastuzumab
• carboplatin
• docetaxel
• lapatinib ditosylate

Primary outcomes

• Proportion of Patients Experiencing Grade 3 or 4 Diarrhea as Measured by NCI CTCAE v3.0 — Up to 10 years

Countries

United States