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Sponsored by: |
University of Oxford |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003016 |
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by reducing the production of estrogen. It is not yet known if prolonged tamoxifen is more effective than shorter tamoxifen therapy following curative treatment for breast cancer.
PURPOSE: This randomized phase III trial is studying giving tamoxifen over a prolonged period of time to see how well it works compared to giving tamoxifen over a shorter period of time in treating patients who have had a breast tumor 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: | Reliable Assessment of the Efficacy and Safety of Prolonging the Use of Adjuvant Tamoxifen: A Large, Simple, Randomised Study |
Estimated Enrollment: | 20000 |
Study Start Date: | October 1995 |
OBJECTIVES:
OUTLINE: This is a randomized study. After about 5 years of adjuvant tamoxifen, recurrence-free patients are randomized to stop tamoxifen treatment immediately or to continue tamoxifen treatment for at least 5 more years.
Patients are followed annually.
PROJECTED ACCRUAL: Approximately 20,000 patients will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Currently taking adjuvant tamoxifen
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United Kingdom, England | |
Atlas Trial Office | |
Oxford, England, United Kingdom, OX2 6HE |
Study Chair: | Rodrigo Arriagada, MD | Karolinska University Hospital - Solna |
Study ID Numbers: | CDR0000065596, ATLAS, EU-96064 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003016 History of Changes |
Health Authority: | United States: Federal Government |
stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Estrogen Antagonists Estrogens Skin Diseases Antineoplastic Agents, Hormonal Hormone Antagonists Citric Acid Adjuvants, Immunologic Hormones, Hormone Substitutes, and Hormone Antagonists |
Breast Neoplasms Bone Density Conservation Agents Selective Estrogen Receptor Modulators Tamoxifen Hormones Estrogen Receptor Modulators Citrate Breast Diseases |
Estrogen Antagonists Skin Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Bone Density Conservation Agents |
Selective Estrogen Receptor Modulators Tamoxifen Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Breast Diseases |