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Sponsored by: |
University Hospital Birmingham |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003678 |
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of at least 2 years of tamoxifen with that of 5 additional years of tamoxifen in treating women who have breast cancer that has been surgically removed.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: tamoxifen citrate Procedure: adjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Large, Uniquely Simple, Randomised Study to Assess Much More Reliably the Balance of Benefits and Risks of Prolonging Adjuvant Tamoxifen Treatment in Early Breast Cancer |
Estimated Enrollment: | 20000 |
Study Start Date: | May 1991 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified for analysis according to duration of tamoxifen given before randomization (2-3 years vs 4-5 years vs 6-7 years vs 8-9 years vs 10 years and over), age (less than 49 vs over 50), and important prognostic factors, including tumor type and grade and nodal and estrogen receptor status. Patients are randomized to 1 of 2 treatment arms.
Patients are followed annually.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 8,000-20,000 patients will be accrued for this study.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast carcinoma that has been completely excised
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United Kingdom, England | |
Cancer Research UK Clinical Trials Unit - Birmingham | |
Birmingham, England, United Kingdom, B15 2TT |
Study Chair: | Daniel Rea, MD | University Hospital Birmingham |
Study ID Numbers: | CDR0000066779, CRC-TU-ATTOM, EU-98042, ISRCTN17222211 |
Study First Received: | November 1, 1999 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003678 |
Health Authority: | United States: Federal Government |
stage I breast cancer stage II breast cancer |
Skin Diseases Citric Acid Breast Neoplasms Tamoxifen Breast Diseases |
Estrogen Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents |
Selective Estrogen Receptor Modulators Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses |