Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00054587
- Lead Sponsor
- UNICANCER
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy with or without trastuzumab is more effective in treating breast cancer.
PURPOSE: Randomized phase III trial to compare two different chemotherapy regimens plus radiation therapy with or without trastuzumab in treating women who have breast cancer that has spread to lymph nodes in the axilla (under the arm).
- Detailed Description
OBJECTIVES:
* 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 regimens.
* Determine the efficacy and tolerability of trastuzumab in patients with hormone receptor-positive tumors.
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 3010
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 6 FEC Trastuzumab 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. 6 FEC Cyclophosphamide 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. 6 FEC Epirubicin 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. 6 FEC Fluorouracil 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. 6 DE Trastuzumab 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 6 DE docetaxel 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 6 DE Epirubicin 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
- Primary Outcome Measures
Name Time Method Progression Free Survival 5 years from randomization
- Secondary Outcome Measures
Name Time Method Herceptin safety 5 years from randomization Overall survival 5 years from randomization
Trial Locations
- Locations (29)
Centre Hospitalier de Mulhouse
🇫🇷Mulhouse, France
Institut Prive de Cancerologie
🇫🇷Grenoble, France
Centre Paul Papin
🇫🇷Angers, France
C.H. Bourg En Bresse
🇫🇷Bourg En Bresse, France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
🇫🇷Dijon, France
Hopital Andre Mignot
🇫🇷Le Chesnay, France
Centre Hospitalier d'Annecy
🇫🇷Annecy, France
Institut Bergonie
🇫🇷Bordeaux, France
Clinique du Petit Colmouilins
🇫🇷Harfleur, France
Institut J. Paoli and I. Calmettes
🇫🇷Marseille, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Hopital Intercommunal De Creteil
🇫🇷Creteil, France
Centre Regional Francois Baclesse
🇫🇷Caen, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Clinique Saint - Pierre
🇫🇷Perpignan, France
Hopital Avicenne
🇫🇷Paris, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Centre Hospitalier de Lagny
🇫🇷Lagny Sur Marne, France
CMC Les Ormeaux
🇫🇷Le Havre, France
Centre Hospitalier Regional Metz Thionville
🇫🇷Metz, France
Centre Hospitalier General Andre Boulloche
🇫🇷Montbeliard, France
Centre Regional Rene Gauducheau
🇫🇷Nantes-Saint Herblain, France
Institut Jean Godinot
🇫🇷Reims, France
Centre Eugene Marquis
🇫🇷Rennes, France
Hopitaux Universitaire de Strasbourg
🇫🇷Strasbourg, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Institut Claudius Regaud
🇫🇷Toulouse, France
CHU Poitiers
🇫🇷Poitiers, France
Clinique Sainte Clotilde
🇫🇷Sainte Clotilde, France