Spots Global Cancer Trial Database for Tamoxifen With or Without Octreotide in Treating Postmenopausal Women With Stage I, Stage II, or Stage III Breast Cancer
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Trial Identification
Brief Title: Tamoxifen With or Without Octreotide in Treating Postmenopausal Women With Stage I, Stage II, or Stage III Breast Cancer
Official Title: A Randomized Trial of Antiestrogen Therapy Versus Combined Antiestrogen and Octreotide Therapy in the Adjuvant Treatment of Breast Cancer in Post-Menopausal Women
Study ID: NCT00002864
Conditions
Study Description
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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Duluth Clinic, Duluth, Minnesota, United States
St. Mary's/Duluth Clinic Health System, Duluth, Minnesota, United States
British Columbia Cancer Agency - Fraser Valley Cancer Centre, Surrey, British Columbia, Canada
BC Cancer Agency, Vancouver, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre, Victoria, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada
Royal Victoria Hospital, Barrie, Barrie, Ontario, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre, Hamilton, Ontario, Canada
Kingston Regional Cancer Centre, Kingston, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre, London, Ontario, Canada
Trillium Health Centre, Mississauga, Ontario, Canada
Credit Valley Hospital, Mississauga, Ontario, Canada
North York General Hospital, Ontario, North York, Ontario, Canada
Lakeridge Health Oshawa, Oshawa, Ontario, Canada
Ottawa Regional Cancer Center - General Division, Ottawa, Ontario, Canada
Ottawa Regional Cancer Centre - Civic Campus, Ottawa, Ontario, Canada
Algoma District Medical Group, Sault Sainte Marie, Ontario, Canada
Hotel Dieu Hospital - St. Catharines, St. Catharines, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury, Sudbury, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay, Thunder Bay, Ontario, Canada
Toronto East General Hospital, Toronto, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada
St. Michael's Hospital - Toronto, Toronto, Ontario, Canada
Mount Sinai Hospital - Toronto, Toronto, Ontario, Canada
Toronto General Hospital, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Women's College Campus, Sunnybrook and Women's College Health Science Center, Toronto, Ontario, Canada
Saint Joseph's Health Centre - Toronto, Toronto, Ontario, Canada
Humber River Regional Hospital, Weston, Ontario, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre, Windsor, Ontario, Canada
Queen Elizabeth Hospital, PEI, Charlottetown, Prince Edward Island, Canada
Centre Universitaire de Sante de l'Estrie - Site Fleurimont, Fleurimont, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
McGill University Department of Oncology, Montreal, Quebec, 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
L'Hopital Laval, Ste-Foy, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Contact Details
Name: Michael N. Pollak, MD
Affiliation: Jewish General Hospital
Role: STUDY_CHAIR
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