ANZ 02P2 / International Breast cancer Intervention Study: IBIS-II DCIS

Phase 3

Completed

• Conditions: Increased breast cancer risk; Cancer - Breast

• Registration Number: ACTRN12605000282684
• 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: 2005-09-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 4000

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine if anastrozole is at least as effective as tamoxifen in local control and prevention of contralateral disease in women with unilateral locally excised ER and/or PgR +ve DCIS.[The expected number of new cancers in each arm will be analysed after 5 years of median follow up];To compare side effect profiles of tamoxifen and anastrozole.[The expected number of new cancers in each arm will be analysed after 5 years of median follow up]