Tamoxifen With or Without Octreotide in Treating Postmenopausal Women With Stage I, Stage II, or Stage III Breast Cancer
- Registration Number
- NCT00002864
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen with or without octreotide may fight breast cancer by blocking the uptake of estrogen. It is not yet known which treatment regimen is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without octreotide in treating postmenopausal women who have stage I, stage II, or stage III breast cancer.
- Detailed Description
OBJECTIVES: I. Compare event-free, recurrence-free, and overall survival following adjuvant therapy with tamoxifen alone vs. tamoxifen plus octreotide long-acting release formulation in postmenopausal women with stage I/II/III breast cancer. II. Compare the toxicity and quality of life associated with each treatment regimen. III. Compare the effects of each treatment regimen on insulin-like growth factor-I (IGF-I) physiology, and study the relationship between IGF-I physiology and outcome.
OUTLINE: This is a randomized study. Patients are stratified by participating institution, when and whether they receive adjuvant chemotherapy, axillary lymph node status, and hormone receptor status. All patients are randomized within 12 weeks of definitive surgery. Patients receiving adjuvant chemotherapy prior to protocol treatment are randomized within 6 weeks after the last dose of chemotherapy. One group of patients receives daily oral tamoxifen, while a second group receives daily oral tamoxifen plus octreotide (long-acting release formulation) by monthly depot injection. Treatment in both groups continues for 5 years or until disease recurrence or development of a second malignancy. Patients are followed monthly for 4 months, every 4 months for 3 years, and every 6 months thereafter.
PROJECTED ACCRUAL: A total of 850 patients will be entered over 4.2 years in this multicenter study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 667
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Octreotide octreotide acetate - Tamoxifen tamoxifen citrate -
- Primary Outcome Measures
Name Time Method Event-free survival 6 years
- Secondary Outcome Measures
Name Time Method Recurrence-free survival 6 years Overall survival 6 years Insulin-like growth factor measures 6 years Quality of Life 6 years
Trial Locations
- Locations (40)
Duluth Clinic
🇺🇸Duluth, Minnesota, United States
BC Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Royal Victoria Hospital, Barrie
🇨🇦Barrie, Ontario, Canada
Kingston Regional Cancer Centre
🇨🇦Kingston, Ontario, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
🇨🇦Victoria, British Columbia, Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
St. Michael's Hospital - Toronto
🇨🇦Toronto, Ontario, Canada
Women's College Campus, Sunnybrook and Women's College Health Science Center
🇨🇦Toronto, Ontario, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
🇨🇦Sudbury, Ontario, Canada
Queen Elizabeth Hospital, PEI
🇨🇦Charlottetown, Prince Edward Island, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
St. Mary's/Duluth Clinic Health System
🇺🇸Duluth, Minnesota, United States
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Algoma District Medical Group
🇨🇦Sault Sainte Marie, Ontario, Canada
Ottawa Regional Cancer Center - General Division
🇨🇦Ottawa, Ontario, Canada
Ottawa Regional Cancer Centre - Civic Campus
🇨🇦Ottawa, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
🇨🇦Thunder Bay, Ontario, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Toronto East General Hospital
🇨🇦Toronto, Ontario, Canada
Mount Sinai Hospital - Toronto
🇨🇦Toronto, Ontario, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Humber River Regional Hospital
🇨🇦Weston, Ontario, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
🇨🇦Windsor, Ontario, Canada
Centre Universitaire de Sante de l'Estrie - Site Fleurimont
🇨🇦Fleurimont, Quebec, Canada
McGill University Department of Oncology
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier de l'Universite' de Montreal
🇨🇦Montreal, Quebec, Canada
L'Hopital Laval
🇨🇦Ste-Foy, Quebec, Canada
Trillium Health Centre
🇨🇦Mississauga, Ontario, Canada
Lakeridge Health Oshawa
🇨🇦Oshawa, Ontario, Canada
Credit Valley Hospital
🇨🇦Mississauga, Ontario, Canada
North York General Hospital, Ontario
🇨🇦North York, Ontario, Canada
Hotel Dieu Hospital - St. Catharines
🇨🇦St. Catharines, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
Hotel Dieu de Montreal
🇨🇦Montreal, Quebec, Canada
Hopital du Saint-Sacrament, Quebec
🇨🇦Quebec City, Quebec, Canada
Saint Joseph's Health Centre - Toronto
🇨🇦Toronto, Ontario, Canada