Randomized And Multicentric Opened Phase III Study Evaluating The Concomitant Administration Of Docetaxel 75MG/M2 and Epirubicine 75MG/M2 Versus FEC 100 In Non Metastatic With Positive Lymphatic Nodes Breast Cancer Subjects, And The Sequential Addition Of Herceptin In (HER2+++) And (HER2++ And FISH+) Subjects
- Compare the efficacy of adjuvant cyclophosphamide, epirubicin, and fluorouracil vs
adjuvant docetaxel and epirubicin, in terms of 5-year survival without relapse, in
women with nonmetastatic adenocarcinoma of the breast with lymph node invasion.
- Determine survival of patients treated with these regimens.
- Compare the tolerability of trastuzumab (Herceptin) in patients treated with these
- Determine the efficacy and tolerability of trastuzumab in patients with hormone
- Evaluate the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to participating center. Patients are treated in 2 parts.
- Part I: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive fluorouracil IV, or epirubicin IV, and cyclophosphamide IV
on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo
radiotherapy 5 days a week for 5 weeks.
- Arm II: Patients receive epirubicin IV over 10 minutes and docetaxel IV over 1
hour on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then
undergo radiotherapy as in arm I.
Patients with HER2/neu-positive tumors then proceed to part II. Patients with
HER2/neu-negative tumors receive no further treatment.
Patients with hormone (estrogen or progesterone) receptor-positive tumors also receive oral
tamoxifen daily beginning after chemotherapy is completed and continuing for 5 years.
- Part II: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes every 3
weeks for 1 year.
- Arm II: Patients are followed without treatment. Patients not receiving
trastuzumab are followed at 4 months, 6 months, every 4 months for 1 year, and
then every 6 months for 3 years. Patients receiving trastuzumab are followed at 4
months and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 2,600 patients will be accrued for this study within 3 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Marc Spielmann, MD
Gustave Roussy, Cancer Campus, Grand Paris
United States: Federal Government