Standard Chemotherapy Compared With High-Dose Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer
NCT ID: NCT00002755
Last Updated: 2013-11-06
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
600 participants
INTERVENTIONAL
1995-11-30
1999-06-30
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of standard cyclophosphamide, methotrexate, and fluorouracil with that of high-dose combination chemotherapy plus peripheral stem cell transplantation in treating women who have stage II or stage IIIA breast cancer.
Detailed Description
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OUTLINE: This is a randomized, multicenter study. Patients are stratified by the number of positive axillary nodes (4-9 vs at least 10) and by center. Patients are randomized to one of two treatment arms. Arm I: Patients receive induction therapy consisting of doxorubicin IV every 3 weeks for 4 courses followed by consolidation therapy consisting of cyclophosphamide IV, methotrexate IV, and fluorouracil IV every 3 weeks for 8 courses. At week 4 of consolidation therapy, patients receive radiotherapy to the breast, chest wall, and axilla over 3-5 weeks or as appropriate. Following recovery from consolidation therapy, patients receive maintenance therapy consisting of oral tamoxifen daily for 5 years. Arm II: Patients receive induction therapy as in arm I followed by consolidation therapy consisting of stem cell mobilization with high dose cyclophosphamide IV over 2 hours and filgrastim (G-CSF) subcutaneously beginning 24 hours after cyclophosphamide and continuing until blood counts recover. At 13-28 days following peripheral blood stem cell (PBSC) collection and/or autologous bone marrow collection, patients undergo chemoablation consisting of thiotepa IV and cyclophosphamide IV continuously over 4 days followed 72 hours later by PBSC infusion with or without autologous bone marrow. Following hematologic recovery, patients receive radiotherapy and maintenance therapy as in arm I. Patients are followed every 6 months for 2 years, then annually.
PROJECTED ACCRUAL: More than 600 patients will be accrued for this study over 5 years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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methotrexate
tamoxifen citrate
thiotepa
autologous bone marrow transplantation
peripheral blood stem cell transplantation
low-LET cobalt-60 gamma ray therapy
low-LET electron therapy
low-LET photon therapy
filgrastim
CMF regimen
cyclophosphamide
doxorubicin hydrochloride
fluorouracil
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: Over 18 Sex: Female Menopausal status: Not specified Performance status: ECOG 0 or 1 Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL PT and aPTT normal Hepatic: Bilirubin normal (unless benign congenital hyperbilirubinemia) Normal liver biopsy required in patients with active hepatitis B or C Renal: Creatinine normal Cardiovascular: No active heart disease Normal wall motion on MUGA or echocardiogram Other: Adequate nutritional status (i.e., more than 1,000 calories/day orally) HIV negative No serious medical or psychiatric disease No second malignancy except: Basal cell skin cancer Carinoma in situ of the cervix Not pregnant Negative pregnancy test
PRIOR CONCURRENT THERAPY: At least 2 weeks since major surgery
18 Years
FEMALE
No
Sponsors
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Scottish Cancer Therapy Network
OTHER
Principal Investigators
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Robert C.F. Leonard, MD, BS, MB
Role: STUDY_CHAIR
Edinburgh Cancer Centre at Western General Hospital
Locations
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St. Vincent's Hospital
Dublin, , Ireland
Addenbrooke's NHS Trust
Cambridge, England, United Kingdom
Cheltenham General Hospital
Cheltenham, England, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom
Royal Free Hospital
Hampstead, London, England, United Kingdom
Northwick Park Hospital
Harrow, England, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, United Kingdom
St. James's Hospital
Leeds, England, United Kingdom
St. George's Hospital
London, England, United Kingdom
Middlesex Hospital- Meyerstein Institute
London, England, United Kingdom
Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Weston Park Hospital
Sheffield, England, United Kingdom
Royal South Hants Hospital
Southampton, England, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Royal Infirmary
Edinburgh, Scotland, United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom
Royal Infirmary
Glasgow, Scotland, United Kingdom
Velindre Hospital
Cardiff, Wales, United Kingdom
Countries
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Other Identifiers
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SCTN-BR9405
Identifier Type: -
Identifier Source: secondary_id
EU-95048
Identifier Type: -
Identifier Source: secondary_id
CDR0000064692
Identifier Type: -
Identifier Source: org_study_id