Docetaxel, Carboplatin, and Trastuzumab and/or Lapatinib in Treating Women With Stage I, Stage II, or Stage III Breast Cancer That Can Be Removed by Surgery
NCT00769470 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2016-01-22
Summary
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. It is not yet known whether docetaxel and carboplatin are more effective when given together with trastuzumab and/or lapatinib in treating women with stage I, stage II, or stage III breast cancer.
PURPOSE: This randomized phase II trial is studying how well docetaxel and carboplatin work when given together with trastuzumab and/or lapatinib in treating women with stage I, stage II, or stage III breast cancer that can be removed by surgery.
Conditions
Interventions
- BIOLOGICAL
-
Given IV
- DRUG
-
Given IV
- DRUG
-
Given IV
- DRUG
-
lapatinib ditosylate
Given orally
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
University of California, Los Angeles
collaborator OTHER -
Translational Oncology Research International
lead OTHER
Principal Investigators
-
Sara Hurvitz, MD · Jonsson Comprehensive Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-04-30
- Primary Completion
- 2013-11-30
Countries
- United States
Study Locations
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