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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT05153135
Eligibility Criteria:
Inclusion Criteria:
\- Evidence of treatment with a CDK4/6 inhibitor regardless of the line of therapy.
The initiation of the first CDK4/6 inhibitor was defined as the index date, and the first CDK4/6 inhibitor initiated was defined as the index treatment
* BC diagnosis: Two diagnosis codes of BC (International Classification of Diseases, 9th Revision, Clinical Modification \[ICD-9-CM\]: 174.xx and International Classification of Diseases, 10th Revision, Clinical Modification \[ICD-10-CM\]: C50.xx \[excluding C50.x2 - male BC\]) on two medical service claims separated by at least 30 days
* Metastatic disease diagnosis: At least two medical claims for a secondary neoplasm (ICD-9-CM codes: 196.xx-197.xx, 198.xx, ICD-10-CM codes: C77.xx, C78.xx, C79.xx) on separate dates, with the first one occurring no more than 30 days before the first diagnosis for BC
* HR+/HER2-: At least one prescription fill or administration of an ET (anastrazole, exemestane, ethinyl estradiol, fulvestrant, fluoxymesterone, letrozole, megestrol acetate, tamoxifen, or toremifene), HR+/HER2- therapy (everolimus), or CDK4/6 inhibitor (i.e., abemaciclib, palbociclib, or ribociclib) at any time following the diagnosis of BC, and no claims for treatments indicated for HER2+ BC, including trastuzumab, lapatinib, afatinib, pertuzumab, or ado-trastuzumab, at any time in the data period
* Women of at least 18 years of age as of the index date
* At least 6 months of continuous health plan coverage prior to and at least 1 month of continuous health plan coverage after the index date
Exclusion Criteria:
* None
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05153135
Study Brief:
Protocol Section:
NCT05153135