Trastuzumab for 6 Months or 1 Year in Treating Women With Nonmetastatic Breast Cancer That Can Be Removed By Surgery
- Conditions
- Breast Cancer
- Registration Number
- NCT00381901
- Lead Sponsor
- National Cancer Institute, France
- Brief Summary
RATIONALE: 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. It is not yet known whether giving trastuzumab for 6 months is as effective as giving trastuzumab for 1 year in treating patients with breast cancer.
PURPOSE: This randomized phase III trial is studying trastuzumab to see how well it works when given for 6 months compared to 12 months in treating women with nonmetastatic breast cancer that can be removed by surgery.
- Detailed Description
OBJECTIVES:
Primary
* Compare the disease-free survival of women with nonmetastatic, resectable breast cancer treated with adjuvant trastuzumab (Herceptin®) for 6 months vs 12 months.
Secondary
* Compare cardiotoxicity in patients receiving these regimens.
* Compare the cardiotoxicity and disease-free survival of patients receiving concurrent trastuzumab and chemotherapy vs sequential administration.
* Correlate HER-2 polymorphism with disease-free survival/cardiotoxicity in these patients.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to participating center, modality of adjuvant chemotherapy (concurrent vs sequential), and adjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
* Arm I (control arm, 12-month therapy): Patients continue to receive trastuzumab (Herceptin®) IV until a total of 12 months of therapy is completed in the absence of disease progression or unacceptable toxicity.
* Arm II (experimental arm, 6-month therapy): Patients continue to receive trastuzumab\* IV until a total of 6 months of therapy is completed in the absence of disease progression or unacceptable toxicity.
NOTE: \*Patients who have already finished 6 months of trastuzumab at randomization do not receive further trastuzumab.
Some patients undergo blood collection for HER-2 polymorphism analysis.
After completion of study therapy, patients are followed periodically for approximately 5 years.
PROJECTED ACCRUAL: A total of 7,000 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 3400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to recurrence
- Secondary Outcome Measures
Name Time Method Cardiotoxicity as measured by LVEF Distant metastasis-free survival Overall survival
Trial Locations
- Locations (81)
C.H.U. de Brest
🇫🇷Brest, France
Hopital Louis Pasteur
🇫🇷Colmar, France
Centre Hospital Regional Universitaire de Limoges
🇫🇷Limoges, France
Centre Paul Papin
🇫🇷Angers, France
C.H.G. Beauvais
🇫🇷Beauvais, France
Centre Hospitalier General
🇫🇷Brive, France
Clinique Notre Dame du Bon Secours
🇫🇷Chartres, France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
🇫🇷Dijon, France
Clinique Sainte-Marguerite
🇫🇷Hyeres, France
Centre De Radiotherapie Charlebourg
🇫🇷La Garenne Colombes, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Hopital Edouard Herriot - Lyon
🇫🇷Lyon, France
Centre Hospitalier Departemental
🇫🇷La Roche Sur Yon, France
Hopital Andre Mignot
🇫🇷Le Chesnay, France
Hopital Clinique Claude Bernard
🇫🇷Metz, France
Centre de Radiologie et de Traitement des Tumeurs
🇫🇷Meudon La Foret, France
Centre Hospitalier de Montelimar
🇫🇷Montelimar, France
Clinique Les Genets
🇫🇷Narbonne, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Centre Hospitalier Intercommunal de Poissy
🇫🇷Poissy, France
Centre Hospitalier La Fontonne
🇫🇷Antibes, France
Institut Sainte Catherine
🇫🇷Avignon, France
Centre Hospitalier Victor Dupouy
🇫🇷Argenteuil, France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
Hopital Avicenne
🇫🇷Bobigny, France
Institut Bergonie
🇫🇷Bordeaux, France
Polyclinique Bordeaux Nord Aquitaine
🇫🇷Bordeaux, France
Clinique Tivoli
🇫🇷Bordeaux, France
Centre Hospitalier Docteur Duchenne
🇫🇷Boulogne Sur Mer, France
Clinique Victor Hugo
🇫🇷Le Mans, France
Centre Hospitalier de Montlucon
🇫🇷Montlucon, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Centre Azureen de Cancerologie
🇫🇷Mougins, France
Centre Catherine de Sienne
🇫🇷Nantes, France
Clinique Hartmann
🇫🇷Neuilly sur Seine, France
Clinique Belvedere
🇫🇷Nice, France
Clinique Saint George
🇫🇷Nice, France
C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
🇫🇷Nimes, France
Clinique De Valdegour
🇫🇷Nimes, France
Hopital Europeen Georges Pompidou
🇫🇷Paris, France
Institut Curie Hopital
🇫🇷Paris, France
Hopital Saint-Louis
🇫🇷Paris, France
CHU Pitie-Salpetriere
🇫🇷Paris, France
Polyclinique Francheville
🇫🇷Perigueux, France
Clinique Saint - Pierre
🇫🇷Perpignan, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Institut Jean Godinot
🇫🇷Reims, France
Hopital Jean Bernard
🇫🇷Poitiers, France
Centre Eugene Marquis
🇫🇷Rennes, France
CHG Roanne
🇫🇷Roanne, France
Clinique Armoricaine De Radiologie
🇫🇷Saint Brieuc, France
Centre Henri Becquerel
🇫🇷Rouen, France
Institut de Cancerologie de la Loire
🇫🇷Saint Priest en Jarez, France
Centre Etienne Dolet
🇫🇷Saint-Nazaire, France
Clinique Sainte Clotilde
🇫🇷Sainte Clotilde, France
Clinique de l'Orangerie
🇫🇷Strasbourg, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer
🇫🇷Toulon - Cedex, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Centre Hospitalier Universitaire Bretonneau de Tours
🇫🇷Tours, France
Hopital Jean Monnet
🇫🇷Epinal, France
Centre Hospitalier d'Annecy
🇫🇷Annecy, France
Centre Hospitalier de Dax
🇫🇷Dax, France
Centre de Radiotherapie et Oncologie Saint-Faron
🇫🇷Mareuil Les Meaux, France
Hopital Clarac
🇫🇷Fort de France Cedex, France
Institut d'Oncologie Hartmann
🇫🇷Levallois-Perret, France
Hopital Robert Boulin
🇫🇷Libourne, France
Clinique Chenieux
🇫🇷Limoges, France
Centre Hospitalier General de Mont de Marsan
🇫🇷Mont-de-Marsan, France
Centre Medical Parot
🇫🇷Lyon, France
Centre Hospitalier William Morey
🇫🇷Chalon-sur-Saone, France
Centre Leon Berard
🇫🇷Lyon, France
Centre Hospital General Robert Ballanger
🇫🇷Aulnay Sous Bois, France
Institut Prive de Cancerologie
🇫🇷Grenoble, France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
🇫🇷Marseille, France
Clinique Clementville
🇫🇷Montpellier, France
Hopital Antoine Beclere
🇫🇷Clamart, France
Centre Hospitalier de Lagny
🇫🇷Lagny Sur Marne, France
CH Meulan
🇫🇷Meulan, France
Centre Regional Rene Gauducheau
🇫🇷Nantes-Saint-Herblain, France
Centre Hospitalier - Pau
🇫🇷Pau, France