Epirubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab in Treating Women With HER2-Positive Stage III or Stage IV Breast Cancer
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.
Drug: epirubicin hydrochloride
Procedure: conventional surgery
Procedure: neoadjuvant therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Neoadjuvant Epirubicin/Cyclophosphamide Followed by Docetaxel Combined With Trastuzumab for the Patients With HER-Positive Advanced Breast Cancer|
- Pathological complete response [ Designated as safety issue: No ]
- Clinical response [ Designated as safety issue: No ]
- Recurrence-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Adverse event [ Designated as safety issue: Yes ]
|Study Start Date:||January 2006|
|Study Completion Date:||September 2012|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
- 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®).
- 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.
|Shikoku Cancer Center|
|Matsuyama-shi, Ehime, Japan, 791-0288|
|National Kyushu Cancer Center|
|Fukuoka-shi, Fukuoka, Japan, 811-1395|
|Niigata Cancer Center Hospital|
|Niigata, Japan, 951-8566|
|Keio University Hospital|
|Tokyo, Japan, 160-8582|
|Teikyo University School of Medicine|
|Tokyo, Japan, 173-8605|
|Study Chair:||Tadashi Ikeda, MD||Teikyo University|