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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT07243002
Eligibility Criteria:
Inclusion Criteria:
* Males or females.
* Diagnosed with breast cancer, as defined by the International Classification of Diseases (ICD), 9th or 10th Revision, Clinical Modification (ICD-9-CM 174.xx, 175.xx/ICD-10-CMC50.xx).
* Aged ≥18 years (or local legal age of consent) at the date of initial breast cancer diagnosis.
* Patients with anatomic staging II and III as determined using American Joint Committee on Cancer (AJCC) Criteria.
* Have initiated adjuvant therapy with ribociclib or abemaciclib, per the approved local label, in combination with ET (within 14 days prior to enrollment).
* Have HR+ status, as determined by the closest biomarker test on or before the adjuvant therapy initiation date:
* Tested positive for estrogen receptor (ER+), or
* Tested positive for progesterone receptor (PR+), or
* Tested positive for both.
* Tested negative for HER2 (HER2-) using the closest biomarker test on or before the adjuvant therapy initiation date.
Exclusion Criteria:
* Patients with local or distant breast cancer recurrence before the ribociclib/abemaciclib initiation date.
* Patients enrolled in clinical trials (receiving treatment with clinical study drugs in any setting, i.e., neoadjuvant, adjuvant, local/regional, metastatic) during the 12-month baseline period.
* Patients physically/mentally incapable of understanding the study requirements or fulfilling data collection instruments and require the support of a legally authorized representative.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07243002
Study Brief:
Protocol Section:
NCT07243002