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 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT05914792
Eligibility Criteria:
Inclusion Criteria:
* early-stage (stages I-III) breast cancer
* estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) and HER2 receptor negative
* able to provide blood samples
* decision made by treating physician and patient to forego upfront surgery in favor of medical management with endocrine therapy
* non-metastatic disease at diagnosis (patients need not have staging scans; patients at higher risk for de novo stage IV disease should not have any symptoms concerning for metastatic disease)
* patients may be taking any endocrine therapy
* patients may be taking any CDK4/6 inhibitor as deemed necessary by their treating physician
* any ECOG Performance Status allowed
* if patients have synchronous bilateral ER+ breast cancer, tissue from both sites should be submitted to Natera to perform ctDNA testing
* patients with multifocal/multicentric tumors are eligible and the largest focus of cancer should be submitted for testing
Exclusion Criteria:
* under 70 years of age
* breast cancer that is not estrogen receptor positive (ER+) or progesterone receptor (PR+)
* unable to provide blood samples or insufficient tumor tissue for Signatera testing
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
70 Years
Study:
NCT05914792
Study Brief:
Protocol Section:
NCT05914792