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Sponsors and Collaborators: |
Queen Mary University of London International Breast Cancer Study Group |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00078832 |
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Anastrozole may be effective in preventing breast cancer.
PURPOSE: This randomized clinical trial is studying how well anastrozole works in preventing breast cancer in postmenopausal women who are at increased risk for the disease.
Condition | Intervention |
---|---|
Breast Cancer |
Drug: anastrozole |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Official Title: | An International Multi-Centre Study Of Anastrozole Versus Placebo In Postmenopausal Women At Increased Risk Of Breast Cancer |
Estimated Enrollment: | 6000 |
Study Start Date: | September 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Participants are stratified according to participating center. Participants are randomized to 1 of 2 treatment arms.
Participants are followed for 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 6,000 participants will be accrued for this study.
Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets at least 1 of the relative risk factors based on age as follows:
45 to 70 years of age:
Two or more first- or second-degree relatives who developed breast cancer or ovarian cancer
60 to 70 years of age:
40 to 44 years of age:
All age groups (40 to 70 ears of age) with a 10-year risk > 5% who do not fit into the above categories are allowed
The following prior breast conditions are allowed (for all age groups):
Hormone receptor status:
For patients with prior DCIS, estrogen- or progesterone-receptor status must have been positive
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Postmenopausal, defined as at least 1 of the following:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
No evidence of osteoporosis or fragility fractures within the spine
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Investigator: | Jack Cuzick, PhD | Cancer Research UK |
Principal Investigator: | Katharina S. Buser, MD | Oncocare Sonnenhof-Klinik Engeriedspital |
Study ID Numbers: | CDR0000353186, CRUK-IBIS-IIB, EU-20227, IBCSG-31-03-PREV, EUDRACT-2004-003991-12 |
Study First Received: | March 8, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00078832 |
Health Authority: | Unspecified |
breast cancer |
Anastrozole Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Aromatase Inhibitors Pharmacologic Actions |