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 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT04514159
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years of age
* Women can be peri- or postmenopausal, as defined by at least one of the following:
* Age ≥ 60 years;
* Age \< 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and follicle-stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females;
* Documented bilateral oophorectomy;
* Must receive a gonadotrophin-releasing hormone agonist beginning at least 4 weeks prior to the first dose of study medication
* Histologically or cytologically confirmed diagnosis of advanced adenocarcinoma of the breast
* Estrogen receptor positive disease
* Human Epidermal Growth Factor Receptor 2 negative disease
* Measurable disease per Response Evaluation Criteria in Solid Tumors v1.1
Exclusion Criteria:
* Prior therapy within the following windows:
* Tamoxifen, aromatase inhibitor, fulvestrant, or other anti-cancer endocrine therapy \< 14 days;
* Any investigational drug therapy \< 28 days or 5 half-lives (whichever is shorter)
* Any prior systemic chemotherapy regardless of the stop date, but the subject must have recovered to eligibility levels from prior toxicity
* Prior treatment with CDK4/6 inhibitors
* Unexplained symptomatic endometrial disorders (including, but not limited to, endometrial hyperplasia, dysfunctional uterine bleeding, or cysts)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04514159
Study Brief:
Protocol Section:
NCT04514159