Epirubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab in Treating Women With HER2-Positive Stage III or Stage IV Breast Cancer

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan; Translational Research Informatics Center, Kobe, Hyogo, Japan
• Treatments: Cyclophosphamide; Docetaxel; Epirubicin; Trastuzumab

Criteria

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