None listed
Conditions
Brief summary
This study aims to determine whether the drug anastrozole can prevent breast cancer in postmenopausal women at increased risk of the disease. Who is it for? You may be eligible join this study if you are a postmenopausal woman aged 40-70 years and are at increased risk of breast cancer. In general terms increased risk is determined from family history, previous benign disease with evidence of proliferation, mammographic dysplasia, and childlessness (nulliparity). Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will take one 1mg anastrozole tablet daily for 5 years. Participants in the other group will take a placebo (inactive) tablet daily for 5 years. Participants will be regularly assessed over the duration of the trial to determine whether anastrozole is effective in preventing breast cancer in postmenopausal women at increased risk of the disease.
Interventions
The ANZ 02P2 / IBIS II trial is conducted by the ANZ Breast Cancer Trials Group (ANZ BCTG) as part of a collaborative project of the Breast Cancer Trials Coordinating Subcommittee of Cancer Research UK and intergroup collaboration.
IBIS-II (Prevention) is designed to continue the work started in IBIS-I in determining whether a chemopreventive strategy towards breast cancer is beneficial. IBIS-I investigated the use of tamoxifen as a preventive agent for women with moderate to increased risk of
The ANZ 02P2 / IBIS II trial is conducted by the ANZ Breast Cancer Trials Group (ANZ BCTG) as part of a collaborative project of the Breast Cancer Trials Coordinating Subcommittee of Cancer Research UK and intergroup collaboration. IBIS-II (Prevention) is designed to continue the work started in IBIS-I in determining whether a chemopreventive strategy towards breast cancer is beneficial. IBIS-I investigated the use of tamoxifen as a preventive agent for women with moderate to increased risk of developing breast cancer. IBIS-II (Prevention) will compare anastrozole vs placebo. IBIS-II (Prevention) is an international multicentre, randomised, placebo-controlled clinical trial of 6,000 postmenopausal women aged between 40 and 70 years who are at increased risk of breast cancer. In general terms increased risk is determined from family history, previous benign disease with evidence of proliferation, mammographic dysplasia, and nulliparity. Women will be randomised in a 2-arm design to receive one of the following: a. Anastrozole 1mg b. Anastrozole placebo All treatment will be on a daily basis for 5 years.
Sponsors
Australia and New Zealand Breast Cancer Trials Group
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. All women must be postmenopausal and between the ages of 40-70. 2. Hormone replacement therapy must be stopped at least 8 weeks prior to randomisation.3. A bilateral mammogram, or unilateral mammogram for women who have had a mastectomy for prior DCIS, must have been taken within the last year and must not show any evidence of breast cancer. 4. A baseline bone mineral density scan within the last two years (DXA either of hip, lumbar spine, femoral neck or forearm) will be required for all women. A spinal x-ray within the last two years to assess low trauma vertebral fractures will also be required.5. Fully informed signed consent must be provided. 6. Fulfill at least one other age-dependent entry criteria which reflects increasing baseline risk with age.7. Must be accessible for treatment and follow up via a participating institution. 8. Participants from the IBIS-I clinical trial who have been off trial therapy for at least 5 years, are eligible to join the IBIS-II clinical trial provided they comply with all other eligibility criteria
Exclusion criteria
1. Premenopausal women.2. Any previous cancer in the last 5 years (except non-melanoma skin cancer, unilateral DCIS treated by mastectomy or in situ cancer of the cervix).3. Current or previous tamoxifen or raloxifene or other SERMs use for more than 3 months. Participants from the IBIS-I clinical trial who have been off trial therapy for at least 5 years are excepted.4. Intention to continue to use oestrogen-based hormone replacement therapy.5. Women who have either had a prophylactic mastectomy or are planning to have this procedure. 6. Women with a T-score of less than -4 or more than 2 low trauma vertebral fractures are not eligible. Women with a T-score of greater than -4 or 2 or less vertebral fractures are eligible if they agree to join the bone substudy or take bisphosphonates and have regular DXA scans. 7. Any severe concomitant disease that would, in the opinion of the investigator, place the woman at unusual risk or confound the results of the trial.8. Life expectancy of less than 10 years or other medical condition that would significantly interfere with the ability to accept the chemopreventive treatments.9. Psychologically and physically unsuitable for five years anti-oestrogen therapy.10. Treatment with non-approved or experimental drug within 3 months before randomisation.11. Women with gluten-sensitivity
Outcome results
None listed