High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Locally Recurrent or Metastatic Breast Cancer
NCT ID: NCT00002870
Last Updated: 2014-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
180 participants
INTERVENTIONAL
1994-12-31
2002-01-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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filgrastim
cyclophosphamide
epirubicin hydrochloride
fluorouracil
thiotepa
peripheral blood stem cell transplantation
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: Under 60 Sex: Women only Menopausal status: Not specified Performance status: WHO 0-2 Life expectancy: Greater than 3 months Hematopoietic: ANC at least 2,000 Platelets at least 100,000 Hepatic: Bilirubin no greater than 2.0 mg/dL (35 micromoles/L) Renal: Creatinine no greater than 1.3 mg/dL (130 micromoles/L) Cardiovascular: No congestive heart failure, even if stable No coronary artery disease No myocardial infarction within 6 months Ventricular ejection fraction (resting) normal by isotopic scan or echocardiogram No evidence of cardiac disease on EKG Other: No active infection No second malignancy except: In situ cervical carcinoma Basal cell skin carcinoma No pregnant women No psychological, familial, social, or geographical contraindication to regular follow-up
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior palliative chemotherapy At least 1 year since adjuvant chemotherapy Maximum prior cumulative anthracycline doses as follows: Epirubicin no greater than 450 mg per square meter Doxorubicin no greater than 300 mg per square meter Pirarubicin no greater than 300 mg per square meter Mitoxantrone no greater than 60 mg per square meter Endocrine therapy: Prior hormonal therapy allowed See Disease Characteristics Radiotherapy: At least 6 weeks since radiotherapy to more than one third of hematopoietic regions Surgery: Not specified
18 Years
59 Years
FEMALE
No
Sponsors
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UNICANCER
OTHER
Principal Investigators
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Pierre Biron, MD
Role: STUDY_CHAIR
Centre Leon Berard
Locations
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Centre Paul Papin
Angers, , France
CHR de Besancon - Hopital Jean Minjoz
Besançon, , France
Clinique Saint Vincent
Besançon, , France
Institut Bergonie
Bordeaux, , France
C.H. Bourg En Bresse
Bourg-en-Bresse, , France
C.H.U. de Brest
Brest, , France
Centre Hospitalier General
Brivé, , France
Centre Regional Francois Baclesse
Caen, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Hopital Louis Pasteur
Colmar, , France
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, , France
Institut Prive de Cancerologie
Grenoble, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
Institut J. Paoli and I. Calmettes
Marseille, , France
Hopital Notre-Dame de Bon Secours
Metz, , France
Hopital Sainte Blandine
Metz, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
Centre Antoine Lacassagne
Nice, , France
Hopital Saint-Louis
Paris, , France
Federation Nationale des Centres de Lutte Contre le Cancer
Paris, , France
Hopital Tenon
Paris, , France
Hopital Haut Leveque
Pessac, , France
Hopital Jean Bernard
Poitiers, , France
Institut Jean Godinot
Reims, , France
Centre Eugene Marquis
Rennes, , France
C.H.U. Saint Etienne Hospital Nord
Saint-Etienne, , France
Hopitaux Universitaire de Strasbourg
Strasbourg, , France
Institut Claudius Regaud
Toulouse, , France
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
CHRU de Nancy - Hopitaux de Brabois
Vandœuvre-lès-Nancy, , France
Countries
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References
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Biron P, Durand M, Roche H, Delozier T, Battista C, Fargeot P, Spaeth D, Bachelot T, Poiget E, Monnot F, Tanguy ML, Cure H. Pegase 03: a prospective randomized phase III trial of FEC with or without high-dose thiotepa, cyclophosphamide and autologous stem cell transplantation in first-line treatment of metastatic breast cancer. Bone Marrow Transplant. 2008 Mar;41(6):555-62. doi: 10.1038/sj.bmt.1705935. Epub 2007 Nov 26.
Biron P, Durand M, Roche H, et al.: High dose thiotepa (TTP), cyclophosphamide (CPM) and stem cell transplantation after 4 FEC 100 compared with 4 FEC alone allowed a better disease free survival but the same overall survival in first line chemotherapy for metastatic breast cancer: results of the PEGASE 03 French protocole. [Abstract] Proceedings of the American Society of Clinical Oncology A-167, 2002.
Other Identifiers
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FRE-FNCLCC-PEGASE03
Identifier Type: -
Identifier Source: secondary_id
EU-96032
Identifier Type: -
Identifier Source: secondary_id
PEGASE03
Identifier Type: -
Identifier Source: org_study_id