Lead Sponsor

Zeno Alpha Inc.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•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

•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)

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