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:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2025-12-24 @ 11:11 PM
NCT ID:
NCT05755269
Eligibility Criteria:
Inclusion Criteria:
* Women who self-identify as African American/Black or Hispanic/Latinx
* Women \>= 30 years old and =\< 75 years old
* Women with any of the following:
* IBIS (Tyrer-Cuzik) score of \>= 5% for the 10 year risk OR
* BCRAT (Gail Model) score of \> 3 % for the 5 year risk
* History of biopsy proven atypical ductal hyperplasia or atypical lobular hyperplasia (with risk calculator assessment A and B)
* History of biopsy proven lobular carcinoma in situ (with risk calculator assessment A and B)
* Able to participate in all aspects of the study
* Understand and signed the study informed consent
Exclusion Criteria:
* Women whose calculated risk for breast cancer falls below the threshold
* Unable to give informed consent
* Prior history of invasive breast cancer, ductal carcinoma in situ or other breast cancers
* Women who are pregnant or breastfeeding
* Prior use of prevention drugs for longer than 6 months
* Prior risk reducing or prophylactic mastectomy
* Known pathogenic genetic mutation linked to breast cancer (such as BRCA 1/2, PALB2, ATM, CHEK2)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT05755269
Study Brief:
Protocol Section:
NCT05755269