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 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT03161834
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years of age
* Female gender
* Biopsy proven diagnosis of breast cancer
* Stage IV disease diagnosed either by radiographic studies or biopsy
* ER+ by immunohistochemistry on primary and/or metastatic tissue biopsy (\>10%)
* HER2 non-amplified (1+ or below by immunohistochemistry, and/or Her2 FISH \<2 HER2-to-CEP17 ratio)
* Progressed on at least one prior line of endocrine therapy for metastatic disease
* Three or fewer prior endocrine-containing therapies for recurrent/metastatic disease
* Two or fewer prior lines of cytotoxic chemotherapy for recurrent/metastatic disease
* Plans to initiate 2nd, 3rd, or 4th line endocrine therapy for metastatic disease
* Recent re-staging scans within 4 weeks of study enrollment, with radiographically identifiable disease
* No concurrent or prior diagnosis of malignancy other than breast cancer for the past 5 years. Patients with a history of in situ cancer or basal or localized squamous cell skin cancer remain eligible
* Intends to pursue treatment as well as clinical and radiographic follow-up at UNC Health Care
* Signed an institutional review board (IRB)-approved informed consent document for this protocol and HIPAA consent form
Exclusion Criteria:
* \< 18 years of age
* Tissue biopsies that support the presence of both ER+ and ER- metastatic breast cancer in the same patient
* Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
* Pregnant or lactating women
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03161834
Study Brief:
Protocol Section:
NCT03161834