International Breast Cancer Intervention Study II (DCIS). An international multi-centre trial of tamoxifen v anastrozole in post-menopausal women with ductal carcinoma in-situ. - IBIS-II (DCIS)
- Conditions
- Ductal carcinoma in situMedDRA version: 17.0 Level: LLT Classification code 10013806 Term: Ductal carcinoma in situ System Organ Class: 100000004864
- Registration Number
- EUCTR2004-003992-35-GB
- Lead Sponsor
- Queen Mary University of London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 4000
The trial is open to post-menopausal women between the ages of 40-70,
with ER or PgR +ve DCIS locally excised within the last six months, in which there are tumour free margins of at least 1mm.
The trial is also open to participants who have had AH or LCIS at any time.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Premenopausal women.
Any previous cancer in the past 5 years (except non-melanoma skin cancer or in situ cancer of the cervix).
Current treatment with anti-coagulants.
Previous deep vein thrombosis or pulmonary embolus, previous transient ischaemic attack (TIA) or cerebrovascular accident (CVA, stroke).
Current or previous tamoxifen or raloxifene or other SERMs use for more than 6 months in the last 5 years. Women in IBIS-I are eligible if they have been off therapy for at least 5 years.
Intention to continue to use oestrogen-based hormone replacement therapy.
Women who have either had a prophylactic mastectomy or are planning to have this procedure.
Any woman with unexplained post-menopausal bleeding.
Women with T-scores of less than minus four or with more than two low trauma vertebral fractures.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method