Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT02517593
Eligibility Criteria:
Inclusion Criteria:
1. Women \> 35 years old and \< 75 years old
2. Women with either of the following:
A. a NCI-BCRAT 5 year risk of ≥ 3% which corresponds to the level in which there is moderate evidence of treatment benefit outweighing risk according to the US Preventative Services Task Force (32); or B. Women with a IBIS (Tyrer-Cuzik) score for the 10 year risk of breast cancer of ≥5%
3. Able to participate in all aspects of the study
4. Understand and signed the study informed consent
Exclusion Criteria:
1. Women whose BCRAT falls below the threshold (\<3 % 5 year risk) of moderate benefit according to the US Preventative Task Force AND Women whose IBIS score is \<5% for the 10 year risk
2. Women with known BRCA1 and BRCA2 mutations
3. Women with known contra-indications to Tamoxifen, raloxifene or exemestane
4. Unable to give informed consent
5. Prior history of invasive breast cancer or ductal carcinoma in situ
6. At risk due to prior radiation therapy to the chest
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT02517593
Study Brief:
Protocol Section:
NCT02517593