Tamoxifen, Ovarian Ablation, and/or Combination Chemotherapy in Treating Premenopausal Women With Stage I, Stage II, or Stage IIIA Invasive Breast Cancer
NCT ID: NCT00002580
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
1000 participants
INTERVENTIONAL
1993-06-30
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with that of ovarian ablation, and/or combination chemotherapy in treating premenopausal women with stage I, stage II, or stage IIIA breast cancer.
Detailed Description
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OUTLINE: This is a randomized, multicenter study. Patients are stratified according to nodal status (positive vs negative or unknown) and hospital region. Patients undergo surgical resection with or without local radiotherapy, as appropriate. Radiotherapy begins within 8 weeks after surgery for patients randomized to arm I or III and within 4 weeks after completion of chemotherapy for patients randomized to arm II or IV. Patients are randomized to 1 of 4 treatment arms, preferably within 2 weeks after surgery. Arm I: Beginning within 4 weeks after surgery, patients receive oral tamoxifen daily. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity. Arm II: Beginning within 4 weeks after surgery, patients receive tamoxifen as in arm I and cyclophosphamide IV, methotrexate IV, and fluorouracil IV (CMF) on day 1. Chemotherapy continues every 3 weeks for 6 courses. Arm III: Beginning within 4 weeks after surgery, patients receive tamoxifen as in arm I and 1 of 3 ovarian suppression regimens, preferably regimen A. Regimen B is the preferred alternative to regimen A. Regimen A: Patients undergo oophorectomy. Regimen B: Patients undergo radiation-induced menopause comprising radiotherapy to the pelvis on days 1-4. Regimen C: Beginning 4 weeks after surgery, patients receive goserelin subcutaneously (SC) or leuprolide SC or intramuscularly on day 1. Treatment continues every 4 weeks for 2 years. Arm IV: Patients receive tamoxifen as in arm I and CMF as in arm II followed within 4 weeks by ovarian suppression as in arm III. Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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cyclophosphamide
fluorouracil
goserelin acetate
leuprolide acetate
methotrexate
tamoxifen citrate
conventional surgery
laparoscopic surgery
oophorectomy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 70 and under Sex: Female Menopausal status: Premenopausal, defined by 1 of the following criteria: Last menstrual period less than 1 year before surgery Under age 50 with prior hysterectomy (for nonmalignant reason) without bilateral oophorectomy Under age 50 and on continuous oral contraception If at variance with the above definitions, hormonal assays in the premenopausal range take precedence Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing No other serious illness No other prior invasive malignancy except adequately treated basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY: Not specified
70 Years
FEMALE
No
Sponsors
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Scottish Cancer Therapy Network
OTHER
Principal Investigators
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W.D. George, MD, MS, FRCS
Role: STUDY_CHAIR
University of Glasgow
Locations
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University Hospitals of Leicester
Leicester, England, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom
University of Glasgow
Glasgow, Scotland, United Kingdom
Raigmore Hospital
Inverness, Scotland, United Kingdom
Royal Alexandra Hospital
Paisley, Scotland, United Kingdom
Ayr Hospital
Ayr, , United Kingdom
Falkirk Royal Infirmary
Falkirk, , United Kingdom
Countries
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References
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Featherstone C, Harnett AN, Brunt AM. Ultrasound localization of the ovaries for radiation-induced ovarian ablation. Clin Oncol (R Coll Radiol). 1999;11(6):393-7. doi: 10.1053/clon.1999.9090.
Other Identifiers
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SCTN-BR9401
Identifier Type: -
Identifier Source: secondary_id
EU-94002
Identifier Type: -
Identifier Source: secondary_id
UKCCCR-ABC/BR9401
Identifier Type: -
Identifier Source: secondary_id
CDR0000063695
Identifier Type: -
Identifier Source: org_study_id