Evaluation of Response Rate to Pre-Operative Docetaxel + Herceptin Study Part A and Docetaxel Study Part B in Locally Advanced Breast Cancer Patients, Stratified by HER2-Status Trial - PHASE II [(Herceptin Docetaxel Neoadjuvant) HEDON]
OBJECTIVES:
- Determine the efficacy of neoadjuvant therapy comprising docetaxel and trastuzumab
(Herceptin®) and adjuvant therapy comprising epirubicin hydrochloride,
cyclophosphamide, and trastuzumab (Herceptin®) followed by radiotherapy in women with
locally advanced, HER2-positive, operable breast cancer.
- Determine the efficacy of neoadjuvant therapy with docetaxel and adjuvant therapy
comprising epirubicin hydrochloride and cyclophosphamide followed by radiotherapy in
women with locally advanced, HER2-negative, operable breast cancer.
OUTLINE: This is an open-label, prospective, multicenter study. Patients are stratified
according to HER2 status (positive vs negative).
- Neoadjuvant therapy:
- Stratum 1 (HER2-positive disease): Patients receive trastuzumab IV over 30-90
minutes on days 1, 8, and 15 and docetaxel IV over 60 minutes on day 1. Treatment
repeats every 3 weeks for up to 6 courses in the absence of disease progression or
unacceptable toxicity
- Stratum 2 (HER2-negative disease): Patients receive docetaxel IV alone as in
stratum 1.
- Surgery: All patients undergo surgery in week 19.
- Adjuvant therapy: Beginning within 2 weeks after surgery, patients receive adjuvant
therapy.
- Stratum 1 (HER2-positive disease): Patients receive trastuzumab IV over 30-90
minutes on days 1, 8, and 15, epirubicin hydrochloride IV over 30 minutes on day
2, and cyclophosphamide IV over 30 minutes on day 2. Treatment repeats every 3
weeks for up to 4 courses in the absence of disease progression or unacceptable
toxicity. Patients then receive trastuzumab IV alone every 3 weeks until week 52.
- Stratum 2 (HER2-negative disease): Patients receive epirubicin hydrochloride and
cyclophosphamide as in stratum 1.
- Radiotherapy: Patients who undergo breast conserving surgery or patients who undergo
mastectomy with ypN positive lymph nodes (i.e., > 4 positive lymph nodes) or ypT3 tumor
(i.e., tumor size > 4 cm) undergo radiotherapy, beginning in approximately week 31 and
continuing until up to week 38.
- Adjuvant endocrine therapy: Patients with estrogen receptor- or progesterone
receptor-positive disease receive adjuvant endocrine therapy beginning in approximately
week 31. Premenopausal patients ≤ 40 years of age receive goserelin for 2-3 years and
tamoxifen citrate for 5 years.Premenopausal patients > 40 years of age receive
tamoxifen citrate for 5 years. Postmenopausal patients receive anastrozole for 5 years
years.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 94 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Rate of pathologic complete remission (pCR) after neoadjuvant therapy comprising docetaxel and trastuzumab (Herceptin®) in women with locally advanced, HER2-positive, operable breast cancer
No
Stefan Paepke, MD
Study Chair
Technische Universität München
United States: Federal Government
CDR0000516034
NCT00398489
October 2006
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