International Breast Cancer Intervention Study II (Prevention). An international multi-centre study of anastrozole vs placebo in postmenopausal women at increased risk of breast cancer.
- Conditions
- Breast CancerMedDRA version: 17.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2004-003991-12-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
- 6000
The trial is open to postmenopausal women between the ages of 40 and 70.
Women aged 40-44 must have at least one of the following:
Two or more 1st or 2nd degree relatives who developed breast cancer at age 50 or less
1st degree relative with bilateral breast cancer who developed the 1st cancer at age 50 or less
Nulliparous (or 1st birth age 30 or above) and 1st degree relative who developed breast cancer at age 40 or above
Benign biopsy with proliferative disease and 1st degree relative who developed breast cancer at age 40 or less.
Women aged 45-70 must have at least one of the following:
1st degree relative who developed breast cancer at age 50 or less, or who developed bilateral breast cancer at any age
Two or more 1st or 2nd degree relatives who developed breast or ovarian cancer.
Nulliparous (or 1st birth at age 30 or above) and 1st degree relative who developed breast cancer
Benign biopsy with proliferative disease and 1st degree relative who developed breast cancer
Mammographic opacityof at least 50% in absence of HRT use within last 3 months
If 60-70, may also have:
1st degree relative with breast cancer at any age
Age at menopause >= 55 yrs
Nulliparous or age at 1st birth 30 or above
In addition, women in all the age groups (40-70) who have had certain breast conditions are also eligible. These are:
Lobular carcinoma in situ (LCIS)
Atypical ductal or lobular hyperplasia in a benign lesion (ADH or LDH)
Ductal carcinoma in situ (DCIS), diagnosed within 6 months prior to randomisation and treated by mastectomy, if ER or PgR positive (>5%)
Women with 10 year risk of breast cancer greater than 5%, who do not fit into any of the above categories may also be eligible.
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 last 5 years (except non-melanoma skin cancer or in situ cancer of cervix).
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 more than 5 years.
Intention to continue to use oestrogen-based HRT.
Had or planning to have prophylactic mastectomy.
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 Main Objective: To determine if anastrozole is effective in preventing breast cancer in postmenopausal women at increased risk of the disease.;<br> Secondary Objective: To examine the role of anastrozole in preventing oestrogen receptor positive breast cancer.<br><br> To examine the effect of anastrozole on breast cancer mortality.<br><br> To examine the effect of anastrozole on other cancers, cardiovascular disease, fracture rates and non-breast cancer deaths.<br><br> To examine tolerability and acceptability of side effects experienced by women on the study.<br> ;Primary end point(s): Development of histologically confirmed breast cancer, both invasive and non-invasive (i.e. including DCIS).;Timepoint(s) of evaluation of this end point: n/a
- Secondary Outcome Measures
Name Time Method Secondary end point(s): n/a;Timepoint(s) of evaluation of this end point: n/a