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About
RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, docetaxel, and capecitabine, 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 find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy together with monoclonal antibodies before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving monoclonal antibodies after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective with or without capecitabine and/or trastuzumab in treating breast cancer.
PURPOSE: This randomized phase III trial is studying epirubicin, cyclophosphamide, and docetaxel to compare how well they work with or without capecitabine and/or trastuzumab before surgery in treating women with stage I, stage II, or stage III breast cancer.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are stratified according to participating site, clinical response after 4 courses of epirubicin hydrochloride and cyclophosphamide (complete response vs partial response vs no change), HER-2/neu-status (negative vs 3+ by immunohistochemistry [IHC] or positive by fluorescence in situ hybridization [FISH]), estrogen receptor (ER)/progesterone receptor (PR) status (ER or PR positive vs ER and PR negative), and extent of disease (T4 or N3 vs T1-3 and N0-2).
All patients receive epirubicin hydrochloride IV over 30-60 minutes and cyclophosphamide IV over 60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then randomized to 1 of 3 treatment arms.
Patients with HER-2/neu-positive tumors also receive trastuzumab (Herceptin®) IV over 90 minutes on day 1 of each course of chemotherapy (during treatment with epirubicin hydrochloride and cyclophosphamide AND during randomized treatment).
Within 2 weeks after completion of chemotherapy, all patients undergo surgery. Within 2 weeks after surgery, patients with HER-2/neu-positive tumors resume trastuzumab treatment for up to 1 year.
After completion of study treatment, patients are followed periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 1,500 patients will be accrued for this study.
Enrollment
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed unilateral or bilateral primary breast cancer
Meets 1 of the following staging criteria:
Disease confirmed by core biopsy
Bidimensionally measurable disease*
Tumor lesion palpable and measures ≥ 2 cm OR tumor lesion ≥ 1 cm in maximum diameter by sonography
Candidate for adjuvant chemotherapy
Known HER-2/neu status by core biopsy
No evidence of distant metastasis
Hormone receptor status:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior chemotherapy for any malignancy
No prior radiation therapy for breast cancer
No concurrent bisphosphonates during chemotherapy
No chronic treatment with corticosteroids unless it is initiated > 6 months prior to study entry and is given at low doses (≤ 20 mg methylprednisolone or equivalent)
No concurrent amifostine during chemotherapy
No concurrent cardioprotectors (e.g., dexrazoxane) during chemotherapy
No concurrent sex hormone therapy
No concurrent virostatic agents (e.g., sorivudine or brivudine)
No concurrent aminoglycosides
No other concurrent experimental drugs or anticancer therapy
At least 30 days since prior participation in another clinical trial with any investigational (not marketed) drug
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Data sourced from clinicaltrials.gov
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