Breast Cancer Clinical Trial
A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer
This is a Phase 1b, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-c5 administered orally in combination with abemaciclib (VERZENIO®) in participants with advanced estrogen-receptor positive, human epidermal growth factor receptor-2 negative (ER+/HER2-) breast cancer.
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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There are 5 Locations for this study
Gilbert Arizona, 85234, United States
Charleston South Carolina, 29414, United States
Grudziądz , 86-30, Poland
Kraków , 30-34, Poland
Łódź , 93-51, Poland
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