Tamoxifen in Treating Women With High-Risk Breast Cancer

Phase 3

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00002542
• Lead Sponsor: NCIC Clinical Trials Group

Brief Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die.

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.

Detailed Description

OBJECTIVES: I. Compare the duration of overall survival and disease-free survival in premenopausal women with operable, high risk node negative or axillary node-positive breast cancer who have undergone complete surgical resection of all known disease by means of total or partial mastectomy, and have received standard adjuvant chemotherapy with cyclophosphamide, methotrexate, and fluorouracil (CMF), cyclophosphamide, epirubicin, and fluorouracil (CEF), or doxorubicin and cyclophosphamide (AC) followed by either daily tamoxifen for 5 years or placebo. II. Compare the short- and long-term toxicity in patients receiving tamoxifen versus placebo. III. Monitor follicle-stimulating hormone, luteinizing hormone, and estradiol levels, and determine whether overall survival and disease-free survival are affected by hormonal or menopausal status during or at completion of adjuvant chemotherapy or during or after tamoxifen or placebo treatment in these patients.

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.

Study Timeline

• Study Start: 1993-07-20
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-07-28
• Study First Posted: 2004-07-29
• Primary Completion: 2007-03-07
• Study Completion: 2011-01-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 672

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (48)

Credit Valley Hospital; 🇨🇦 Mississauga, Canada

Cancer Centre of Southeastern Ontario at Kingston; 🇨🇦 Kingston, Canada

Stronach Regional Health Centre at Southlake; 🇨🇦 Newmarket, Canada

Penticton Regional Hospital; 🇨🇦 Penticton, Canada

CHUQ-Pavillon Hotel-Dieu de Quebec; 🇨🇦 Quebec City, Canada

Saskatoon Cancer Centre; 🇨🇦 Saskatoon, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Canada

St. Joseph's Health Centre; 🇨🇦 Toronto, Canada

Dr. H. Bliss Murphy Cancer Centre; 🇨🇦 St. John's, Newfoundland and Labrador, Canada

The Royal Victoria Hospital; 🇨🇦 Barrie, Canada

QEII Health Sciences Center; 🇨🇦 Halifax, Canada

CHUM - Hopital Notre-Dame; 🇨🇦 Montreal, Canada

Niagara Health System; 🇨🇦 St. Catharines, Canada

William Osler Health Centre, Brampton Memorial; 🇨🇦 Brampton, Canada

L'Hotel-Dieu de Levis; 🇨🇦 Levis, Canada

McGill University - Dept. Oncology; 🇨🇦 Montreal, Canada

Tom Baker Cancer Centre; 🇨🇦 Calgary, Canada

Juravinski Cancer Centre at Hamilton Health Sciences; 🇨🇦 Hamilton, Canada

PEI Cancer Treatment Centre,Queen Elizabeth Hospital; 🇨🇦 Charlottetown, Canada

Cross Cancer Institute; 🇨🇦 Edmonton, Canada

CHA-Hopital Du St-Sacrement; 🇨🇦 Quebec City, Canada

Allan Blair Cancer Centre; 🇨🇦 Regina, Canada

Regional Cancer Program of the Hopital Regional; 🇨🇦 Sudbury, Canada

Centre Hospitalier Regional de Lanaudiere; 🇨🇦 Joliette, Canada

London Regional Cancer Program; 🇨🇦 London, Canada

CHUM - Hotel Dieu du Montreal; 🇨🇦 Montreal, Canada

CHUM - Pavillon Saint-Luc; 🇨🇦 Montreal, Canada

Lakeridge Health Oshawa; 🇨🇦 Oshawa, Canada

BCCA - Fraser Valley Cancer Centre; 🇨🇦 Surrey, Canada

Ottawa Health Research Institute - General Division; 🇨🇦 Ottawa, Canada

Thunder Bay Regional Health Science Centre; 🇨🇦 Thunder Bay, Canada

Peterborough Regional Health Centre; 🇨🇦 Peterborough, Canada

Atlantic Health Sciences Corporation; 🇨🇦 Saint John, Canada

Algoma District Cancer Program; 🇨🇦 Sault Ste. Marie, Canada

University Institute of Cardiology and; 🇨🇦 Quebec, Canada

Univ. Health Network-The Toronto General Hospital; 🇨🇦 Toronto, Canada

Centre hospitalier universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Canada

Toronto East General Hospital; 🇨🇦 Toronto, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Canada

Univ. Health Network-Princess Margaret Hospital; 🇨🇦 Toronto, Canada

Trillium Health Centre - West Toronto; 🇨🇦 Toronto, Canada

CancerCare Manitoba; 🇨🇦 Winnipeg, Canada

Women's College Hospital; 🇨🇦 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

Odette Cancer Centre; 🇨🇦 Toronto, Canada