None listed
Conditions
Brief summary
Phase 3 This study is comparing the effectiveness of the drugs tamoxifen versus anastrozole in postmenopausal women with hormone sensitive ductal carcinoma in situ (DCIS). This is an ANZ 02P2/ International Breast Cancer Intervention Study: IBIS-II DCIS. Who is it for? You can join this trial if: You are a postmenopausal woman aged between 40 and 70 years. You must have had DCIS diagnosed in one breast within the last 6 months. The DCIS must have been hormone sensitive and have been locally removed (i.e.not by mastectomy). Trial details Participants will be randomly divided into two groups. One group receives tamoxifen plus a non-active compound in place of anastrozole. The other group receives anastrozole plus a non-active compound in place of tamoxifen. These are taken orally, every day for 5 years. The study aims to compare how effective the two drugs are in preventing and controlling locally any subsequent disease, in the same or the other breast. DCIS has the potential to develop into breast cancer which can spread to other places in the body. Both tamoxifen and anastrozole lower levels of the hormone oestrogen in the body and are used in women already diagnosed with breast cancer. Tamoxifen is used in some women with DCIS for the prevention of breast cancer. This trial is looking at whether anastrozole is as effective as tamoxifen in preventing further DCIS and breast cancer.
Interventions
Anastrozole 1 mg + Tamoxifen placebo (lactose pill). All treatment will be on a daily basis for 5 years and all women will take 2 tablets/day orally.
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. 2. Hormone replacement therapy must have stopped at least 8 weeks prior to randomisation.3. Locally excised unilateral DCIS diagnosed within the last 6 months. Oestrogen receptor and/or progesterone receptor (ER and/or PgR) status of the DCIS must be known and greater than 5% positive cells.4. A baseline bone mineral density scan within the last 2 years (DXA either of hip, lumbar spine or forearm) will be required for all women. A spinal x-ray within the last 2 years to rule out low trauma vertebral fractures will also be required.5. A bilateral mammogram must have been taken within the last year.6. Fully informed consent must be provided.7. Women treated by mastectomy will not be eligible for this trial, but may enter the parallel IBIS II (Prevention) trial.8. Must be accessible for treatment and follow up via a participating institution. 9. 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 (except non-melanoma skin cancer or in situ cancer of the cervix) in the past 5 years.3. Bilateral DCIS.4. Current treatment with anti-coagulants.5. Previous deep vein thrombosis or pulmonary embolus.6. Previous transient ischaemic attack (TIA) or cerebrovascular accident (CVA, stroke).7. 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.8. Intention to continue to use oestrogen-based hormone replacement therapy.9. Women who have either had a prophylactic mastectomy or are planning to have this procedure. 10. Any woman with unexplained postmenopausal bleeding. 11. Evidence of osteoporosis or low trauma vertebral fractures within the spine. 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.12. 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.13. Life expectancy of less than 10 years or other medical condition which would significantly interfere with the ability to accept the chemopreventive treatments.14. Psychologically and physically unsuitable for five years anti-oestrogen therapy.15. Treatment with non-approved or experimental drug during the 3 months before randomisation.16. Women with gluten-sensitivity.
Outcome results
None listed