Tamoxifen in Treating Women With High-Risk Breast Cancer
NCT ID: NCT00002542
Last Updated: 2020-04-01
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
672 participants
INTERVENTIONAL
1993-07-20
2011-01-11
Brief Summary
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PURPOSE: Phase III trial to study the effectiveness of tamoxifen following surgery and chemotherapy in treating women who have stage I breast cancer at high risk of recurrence or stage II or stage III breast cancer.
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Detailed Description
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OUTLINE: This is a randomized, double blind study. Patients are stratified by adjuvant chemotherapy regimen (cyclophosphamide, epirubicin, and fluorouracil vs cyclophosphamide, methotrexate, and fluorouracil vs cyclophosphamide and doxorubicin), hormone receptor status (ER and/or PR positive vs ER and PR negative), number of positive nodes (1-3 vs 4-9 vs 10 or more), and participating institution. Patients receive one of three regimens of adjuvant chemotherapy at the discretion of the investigator. Regimen A: Patients receive oral cyclophosphamide on days 1-14 and epirubicin IV and fluorouracil IV on days 1 and 8. Courses repeat every 28 days for a total of 6 courses. Following chemotherapy, lumpectomy patients receive local radiotherapy daily for 5 weeks. Regimen B: Patients receive oral cyclophosphamide on days 1-14 or cyclophosphamide IV on day 1 and 8, methotrexate on days 1 and 8, and fluorouracil IV on days 1 and 8. Courses repeat every 28 days for a total of 6 courses. Concurrent with or following chemotherapy, lumpectomy patients receive local radiotherapy daily for 5 weeks. Regimen C: Patients receive doxorubicin IV and cyclophosphamide IV every 21 days for a total of 4 courses. Following chemotherapy, lumpectomy patients receive local radiotherapy daily for 5 weeks. Patients are then randomized to receive either oral tamoxifen or a placebo once daily for 5 years, beginning within 6 weeks of completion of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for survival.
PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study over 4 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Interventions
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CMF regimen
cyclophosphamide
doxorubicin hydrochloride
epirubicin hydrochloride
fluorouracil
methotrexate
tamoxifen citrate
radiation therapy
Eligibility Criteria
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Inclusion Criteria
120 Years
FEMALE
No
Sponsors
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NCIC Clinical Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Vivien HC Bramwell, MB, BS, PhD, FRCP
Role: STUDY_CHAIR
London Health Sciences Centre
Locations
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Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada
The Royal Victoria Hospital
Barrie, , Canada
William Osler Health Centre, Brampton Memorial
Brampton, , Canada
Tom Baker Cancer Centre
Calgary, , Canada
PEI Cancer Treatment Centre,Queen Elizabeth Hospital
Charlottetown, , Canada
Cross Cancer Institute
Edmonton, , Canada
Regional Cancer Program of the Hopital Regional
Greater Sudbury, , Canada
QEII Health Sciences Center
Halifax, , Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, , Canada
Centre Hospitalier Regional de Lanaudiere
Joliette, , Canada
Cancer Centre of Southeastern Ontario at Kingston
Kingston, , Canada
L'Hotel-Dieu de Levis
Lévis, , Canada
London Regional Cancer Program
London, , Canada
Credit Valley Hospital
Mississauga, , Canada
CHUM - Hopital Notre-Dame
Montreal, , Canada
McGill University - Dept. Oncology
Montreal, , Canada
CHUM - Hotel Dieu du Montreal
Montreal, , Canada
CHUM - Pavillon Saint-Luc
Montreal, , Canada
Stronach Regional Health Centre at Southlake
Newmarket, , Canada
Lakeridge Health Oshawa
Oshawa, , Canada
Ottawa Health Research Institute - General Division
Ottawa, , Canada
Penticton Regional Hospital
Penticton, , Canada
Peterborough Regional Health Centre
Peterborough, , Canada
CHUQ-Pavillon Hotel-Dieu de Quebec
Québec, , Canada
CHA-Hopital Du St-Sacrement
Québec, , Canada
University Institute of Cardiology and
Québec, , Canada
Allan Blair Cancer Centre
Regina, , Canada
Atlantic Health Sciences Corporation
Saint John, , Canada
Saskatoon Cancer Centre
Saskatoon, , Canada
Algoma District Cancer Program
Sault Ste. Marie, , Canada
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, , Canada
Niagara Health System
St. Catharines, , Canada
BCCA - Fraser Valley Cancer Centre
Surrey, , Canada
Thunder Bay Regional Health Science Centre
Thunder Bay, , Canada
Toronto East General Hospital
Toronto, , Canada
Odette Cancer Centre
Toronto, , Canada
St. Michael's Hospital
Toronto, , Canada
Mount Sinai Hospital
Toronto, , Canada
Univ. Health Network-The Toronto General Hospital
Toronto, , Canada
Univ. Health Network-Princess Margaret Hospital
Toronto, , Canada
Women's College Hospital
Toronto, , Canada
St. Joseph's Health Centre
Toronto, , Canada
Trillium Health Centre - West Toronto
Toronto, , Canada
Humber River Regional Hospital
Toronto, , Canada
BCCA - Vancouver Cancer Centre
Vancouver, , Canada
BCCA - Vancouver Island Cancer Centre
Victoria, , Canada
Windsor Regional Cancer Centre
Windsor, , Canada
CancerCare Manitoba
Winnipeg, , Canada
Countries
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References
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Bramwell VHC, Pritchard KI, Tu D, et al.: How compliant are patients with oral hormonal therapies? Data from a randomized, placebo controlled study of tamoxifen after adjuvant chemotherapy in premenopausal women with early breast cancer (NCIC CTG MA.12). [Abstract] Breast Cancer Res Treat 106 (1): A-3055, 2007.
Bramwell VH, Pritchard KI, Tu D, et al.: Tamoxifen (T) compared to placebo (P), after adjuvant chemotherapy (CT), in premenopausal women with early breast cancer (EBC): interim results of NCIC-CTG MA.12. [Abstract] J Clin Oncol 25 (Suppl 18): A-547, 2007.
Other Identifiers
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CAN-NCIC-MA12
Identifier Type: -
Identifier Source: secondary_id
NCI-V93-0323
Identifier Type: -
Identifier Source: secondary_id
CDR0000063224
Identifier Type: OTHER
Identifier Source: secondary_id
MA12
Identifier Type: -
Identifier Source: org_study_id
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