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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

A Study of ZN-c5 in Subjects With Breast Cancer

This is a Phase 1 / 2, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZN-c5 administered orally in subjects with advanced estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+ / HER2-) breast cancer. ZN-c5 will be evaluated both as monotherapy and in combination with palbociclib (IBRANCEĀ®).
Not Available
Phase I
Adults
Not Available
Not Available
Abramson, Vandana
International
Vanderbilt University
01-31-2019
Treatment
VICCBREP1899
NCT03560531

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

Inclusion Criteria: - Age ? 18 years of age - Women can be postmenopausal, as defined by at least one of the following: - Age ? 60 years; - Age 6 months - Evaluable or measurable disease by RECIST v1.1. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if progression at the treated site after completion of therapy is clearly documented. Exclusion Criteria: -Prior anticancer or investigational drugs for the treatment of ER+/HER2 negative advanced breast cancer within the following windows: - Tamoxifen, aromatase inhibitor, fulvestrant, or other anti-cancer endocrine therapy

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