Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer
- Registration Number
- NCT00078832
- Lead Sponsor
- Queen Mary University of London
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* Determine the effectiveness of anastrozole in preventing breast cancer in postmenopausal women at increased risk for the disease.
Secondary
* Determine the role of this drug in preventing estrogen receptor-positive breast cancer in these participants.
* Determine the effect of this drug on breast cancer mortality in these participants.
* Determine the effect of this drug on other cancers, cardiovascular disease, fracture rates, and non-breast cancer deaths in these participants.
* Determine the tolerability and acceptability of side effects of this drug in these participants.
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.
* Arm I: Participants receive oral anastrozole daily for 5 years.
* Arm II: Participants receive an oral placebo daily for 5 years. In both arms, treatment continues in the absence of the development of breast cancer (including ductal carcinoma in situ), a drop in the T-score below minus 4, or the occurrence of a new fragility fracture.
Participants are followed for at least a further 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
ACCRUAL: A total of 3,864 participants were recruited for this study over 10 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 3864
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description placebo placebo anastrozole 1mg PLACEBO anastrozole anastrozole anastrozole 1mg
- Primary Outcome Measures
Name Time Method Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years Dec 2013
- Secondary Outcome Measures
Name Time Method Breast cancer mortality with median follow-up at 10 years Dec 2018
Trial Locations
- Locations (73)
Newcastle Mater Hospital
🇦🇺Newcastle, New South Wales, Australia
University Hospitals
🇧🇪Leuven, Belgium
Corporacion Nacional del Cancer
🇨🇱Santiago, Chile
Herlev University Hospital
🇩🇰Horsholm, Denmark
Pirkanmaa Cancer Society
🇫🇮Tampere, Finland
GBG Forschungs GMBH
🇩🇪Frankfurt, Germany
Department of Oncotherapy, University of Szeged
🇭🇺Szeged, Hungary
Beaumont Hospital
🇮🇪Dublin, Beaumont, Ireland
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
🇮🇪Dublin, Tallaght, Ireland
Cork University Hospital
🇮🇪Cork, Ireland
Scroll for more (63 remaining)Newcastle Mater Hospital🇦🇺Newcastle, New South Wales, Australia