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Sponsors and Collaborators: |
Cancer Research UK International Breast Cancer Study Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00072462 |
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using either tamoxifen or anastrozole may fight breast cancer by blocking the use of estrogen. It is not yet known whether tamoxifen is more effective than anastrozole in preventing breast cancer after surgery for ductal carcinoma in situ.
PURPOSE: This randomized phase III trial is studying how well adjuvant tamoxifen works compared to anastrozole in treating postmenopausal women who have undergone surgery to remove ductal carcinoma in situ.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: anastrozole Drug: tamoxifen citrate Procedure: adjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control |
Official Title: | An International Multi-Centre Study Of Tamoxifen Vs Anastrozole In Postmenopausal Women With Ductal Carcinoma In Situ (DCIS) |
Estimated Enrollment: | 4000 |
Study Start Date: | September 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
Patients are followed annually for 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 4,000 patients will be accrued for this study within 4 years.
Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of ductal carcinoma in situ within the past 6 months
Hormone receptor status:
Estrogen or progesterone receptor positive
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Postmenopausal, defined as meeting at least 1 of the following criteria:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Investigator: | Jack Cuzick, PhD | Cancer Research UK |
Study Chair: | Katharina S. Buser, MD | Oncocare Sonnenhof-Klinik Engeriedspital |
Study ID Numbers: | CDR0000339738, CRUK-IBIS-II-DCIS, EU-20226, BIG-5-02, IBCSG-31-03-DCIS, ISRCTN31488319 |
Study First Received: | November 4, 2003 |
Last Updated: | January 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00072462 |
Health Authority: | Unspecified |
ductal breast carcinoma in situ breast cancer in situ |
Anastrozole Skin Diseases Citric Acid Breast Neoplasms Tamoxifen Carcinoma Carcinoma, Ductal |
Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial |
Estrogen Antagonists Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors |
Bone Density Conservation Agents Selective Estrogen Receptor Modulators Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Ductal, Lobular, and Medullary Aromatase Inhibitors |