ANZ 02P2 / International Breast cancer Intervention Study: IBIS-II (Prevention)

Phase 3

Completed

• Conditions: Increased breast cancer risk; Reproductive Health and Childbirth - Menstruation and menopause; Cancer - Breast

• Registration Number: ACTRN12605000216617
• Lead Sponsor: Australia and New Zealand Breast Cancer Trials Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 6000

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified