Title
Epirubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab in Treating Women With HER2-Positive Stage III or Stage IV Breast Cancer
Neoadjuvant Epirubicin/Cyclophosphamide Followed by Docetaxel Combined With Trastuzumab for the Patients With HER-Positive Advanced Breast Cancer
Phase
Phase 2Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Breast CancerIntervention/Treatment
epirubicin trastuzumab cyclophosphamide docetaxel ...Study Participants
38RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, and docetaxel, 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. Giving chemotherapy and a monoclonal antibody before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving epirubicin and cyclophosphamide followed by docetaxel and trastuzumab works in treating women with HER2-positive stage IIIB, stage IIIC, or stage IV primary breast cancer.
OBJECTIVES:
Primary
Determine the pathological complete response in women with HER2-positive stage IIIB-IV breast cancer treated with neoadjuvant epirubicin hydrochloride and cyclophosphamide followed by docetaxel and trastuzumab (Herceptin®).
Secondary
Determine the clinical response in patients treated with this regimen.
Determine the recurrence-free survival of patients treated with this regimen.
Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive epirubicin hydrochloride and cyclophosphamide in weeks 1-3. Treatment with epirubicin hydrochloride and cyclophosphamide repeats every 3 weeks for 4 courses. Patients then receive docetaxel in week 13 and trastuzumab (Herceptin®) in weeks 13-15. Treatment with docetaxel and trastuzumab repeats every 3 weeks for 4 courses.
Patients then undergo appropriate surgery. After surgery, patients with hormone receptor-positive disease receive trastuzumab once weekly and either tamoxifen with or without a luteinizing hormone-releasing hormone agonist or an aromatase inhibitor. Treatment continues for 40 weeks.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Patients receive epirubicin hydrochloride and cyclophosphamide in week 1-3. Treatment with epirubicin hydrochloride and cyclophosphamide repeats every 3 weeks for 4 courses. Patients then receive docetaxel in week 13 and trastuzumab (Herceptin®) in weeks 13-15. Treatment with docetaxel and trastuzumab repeats every 3 weeks for 4 courses. Patients then undergo appropriate surgery. After surgery, patients with hormone receptor-positive disease receive trastuzumab once weekly and either tamoxifen with or without a luteinizing hormone-releasing hormone agonist or an aromatase inhibitor. Treatment continues for 40 weeks.
DISEASE CHARACTERISTICS: Diagnosis of primary breast cancer Stage IIIB, IIIC, or IV disease No inflammatory disease HER2 over-expressing tumor as assessed by immunohistochemistry and/or fluorescent in situ hybridization Hormone receptor status known PATIENT CHARACTERISTICS: Female Menopausal status not specified Performance status 0-1 WBC ≤ 10,000/mm³ Absolute neutrophil count ≥ 2,000/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 9.5 g/dL SGOT/SGPT ≤ 60 IU/L Bilirubin ≤ 1.5 mg/dL Creatinine ≤ 1.5 mg/dL LVEF ≥ 55% No signs of pneumonitis PRIOR CONCURRENT THERAPY: No prior surgery except for biopsy No prior or concurrent chemotherapy and/or hormonal therapy No prior or concurrent biological therapy No prior or concurrent radiotherapy except postoperative radiotherapy
