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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT04474834
Eligibility Criteria:
Inclusion Criteria:
* Women \>= 35 years old and =\< 75 years old with at least one of the following:
* A National Cancer Institute (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 United States (US) Preventative Services Task Force
* IBIS (Tyrer-Cuzik) score for the 10 year risk of breast cancer of \>= 5%
* History atypical ductal hyperplasia or atypical lobular hyperplasia with a BCRAT \>= 3% or IBIS \>= 5%
* History of lobular carcinoma in situ with a BCRAT \>= 3% or IBIS \>= 5% OR
* Women \>= 18 years old or =\< 75 years old with a BRCA 1 or 2 mutation, CHEK 2, PALB 2, ATM, or other hereditary breast mutation carrier per investigator
* Willing and able to provide an email address to receive study surveys
* Able to participate in all aspects of the study
* Understand and sign the study informed consent
Exclusion Criteria:
* 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 \<8% for the 10 year risk
* Women with known contra-indications to Tamoxifen, raloxifene ,exemestane, or anastrazole
* Current or prior use of Tamoxifen, raloxifene, exemestane or anastrazole
* Unable to give informed consent
* Prior history of invasive breast cancer, ductal carcinoma in situ or other breast cancers
* At high risk due to prior radiation therapy to the chest
* Women who are pregnant or breastfeeding
* Prior risk reducing or prophylactic mastectomy
* Unwilling or unable to provide an email address for study surveys to be sent to
* Subject has a known history or any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT04474834
Study Brief:
Protocol Section:
NCT04474834