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Keep this study
Lead
Zeno Alpha Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
Clareo Health | A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer
