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About
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. 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 combination chemotherapy with or without trastuzumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
PURPOSE: This randomized phase II trial is comparing two different regimens of combination chemotherapy given together with or without trastuzumab to see how well they work in treating patients with stage II or stage III breast cancer.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients with non HER2/neu overexpressing tumors are randomized to 1 of 2 treatment arms. Patients with HER2/neu overexpressing tumors are assigned to arm III.
Within 4 weeks after completion of chemotherapy with or without trastuzumab (Herceptin®), all patients undergo surgery.
PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study.
Enrollment
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically proven infiltrating ductal or lobular breast carcinoma
Hormone-receptor status not specified
PATIENT CHARACTERISTICS:
ECOG performance status < 2
Male or female
Menopausal status not specified (for female patients)
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Bilirubin normal (except for patient's with Gilbert's disease)
Creatinine ≤ 1.2 mg/dL
Creatinine clearance ≥ 70 mL/min
Ejection fraction ≥ 50% on MUGA
No neuropathy ≥ grade 1
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective nonhormonal contraception
No prior malignant disease within the past 5 years, excluding:
No noninvasive (in situ) breast carcinoma within the past 5 years
PRIOR CONCURRENT THERAPY:
Primary purpose
Allocation
Interventional model
Masking
121 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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