High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Locally Recurrent or Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00002870
- 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. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs to kill more tumor cells. It is not yet known if high dose chemotherapy plus peripheral stem cell transplantation is more effective than standard therapy for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy plus peripheral stem cell transplantation with that of standard therapy in treating women who have locally recurrent or metastatic breast cancer.
- Detailed Description
OBJECTIVES: I. Evaluate the effect on 3-year survival of intensive chemotherapy with cyclophosphamide/thiotepa with peripheral blood stem cell rescue in women with locally recurrent or metastatic breast cancer who respond to induction therapy with epirubicin/fluorouracil/cyclophosphamide. II. Evaluate the effects of this intensive treatment on patient quality of life. III. Evaluate tumor response and progression-free survival after intensification.
OUTLINE: This is a randomized study. Patients are stratified by clinical/therapeutic hormone sensitivity and participating institution. All patients receive induction therapy with epirubicin, fluorouracil, and cyclophosphamide (FEC 100) every 3 weeks for up to 4 courses, with response evaluated after at least 2 courses. Patients with a complete response or at least a 50% partial response are randomized either to no further therapy or to receive intensification chemotherapy. Patients randomized to intensification undergo peripheral blood stem cell (PBSC) harvest with G-CSF mobilization after the third or fourth induction course. Three to 6 weeks after induction, patients receive intensification chemotherapy with cyclophosphamide/thiotepa followed by PBSC. Post-transplant G-CSF is given for hematopoietic support. No concurrent hormonal therapy is permitted during induction; local irradiation of multifocal tumors is allowed provided response is still evaluable. Local therapy (excision of single metastasis, radiotherapy to metastatic site) is permitted after completion of protocol therapy. Treatment of relapsed disease is at the discretion of the investigator. Patients are followed every 3 months for 3 years or until relapse, then every 6 months.
PROJECTED ACCRUAL: A total of 180 patients will be accrued over 3 years in this multicenter study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 180
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease free survival 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
Centre Paul Papin
🇫🇷Angers, France
Clinique Saint Vincent
🇫🇷Besancon, France
C.H. Bourg En Bresse
🇫🇷Bourg En Bresse, France
Institut Jean Godinot
🇫🇷Reims, France
Centre Hospitalier Universitaire Bretonneau de Tours
🇫🇷Tours, France
CHR de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
Centre Regional Francois Baclesse
🇫🇷Caen, France
Hopital Louis Pasteur
🇫🇷Colmar, France
Institut J. Paoli and I. Calmettes
🇫🇷Marseille, France
Hopitaux Universitaire de Strasbourg
🇫🇷Strasbourg, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
C.H.U. de Brest
🇫🇷Brest, France
Institut Bergonie
🇫🇷Bordeaux, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Centre Hospitalier General
🇫🇷Brive, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
🇫🇷Dijon, France
Institut Prive de Cancerologie
🇫🇷Grenoble, France
Centre Oscar Lambret
🇫🇷Lille, France
Hopital Haut Leveque
🇫🇷Pessac, France
Federation Nationale des Centres de Lutte Contre le Cancer
🇫🇷Paris, France
Hopital Notre-Dame de Bon Secours
🇫🇷Metz, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Hopital Jean Bernard
🇫🇷Poitiers, France
Centre Eugene Marquis
🇫🇷Rennes, France
Centre Leon Berard
🇫🇷Lyon, France
CHRU de Nancy - Hopitaux de Brabois
🇫🇷Vandoeuvre-Les-Nancy, France
Hopital Tenon
🇫🇷Paris, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Hopital Sainte Blandine
🇫🇷Metz, France
C.H.U. Saint Etienne Hospital Nord
🇫🇷Saint Etienne, France
Hopital Saint-Louis
🇫🇷Paris, France