Neoadjuvant Epirubicin/Cyclophosphamide Followed by Docetaxel Combined With Trastuzumab for the Patients With HER-Positive Advanced Breast Cancer
- 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.
Masking: Open Label, Primary Purpose: Treatment
Pathological complete response
Tadashi Ikeda, MD
United States: Federal Government