Loading clinical trials...

A Study of ZN-c5 in Subjects With Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Study of ZN-c5 in Subjects With Breast Cancer

A Phase 1/2 Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of ZN-c5 Alone and in Combination With Palbociclib in Subjects With Estrogen-Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer

NCT03560531•Zeno Alpha Inc.

View on ClinicalTrials.gov

Summary

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 (IBRANCE®).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years of age
•* Women can be 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 level within the laboratory's reference range for postmenopausal females;
•* Documented bilateral oophorectomy; or can be peri- or premenopausal, however, they 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 (metastatic or locoregionally recurrent) adenocarcinoma of the breast, not amenable to any potential curative intervention
•Estrogen Receptor (ER) positive disease
•Human Epidermal Growth Factor Receptor 2 (HER2) negative disease
•Documented prior response to endocrine therapy for metastatic disease (stable disease, partial response, or complete response by RECIST v1.1 criteria) lasting \> 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 \< 14 days before first dose of study treatment
•* Any chemotherapy \< 28 days before first dose of study, except for Phase 2 monotherapy which requires no prior chemotherapy treatment.
•* Any investigational drug therapy \< 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment
•Unexplained symptomatic endometrial disorders (including, but not limited to endometrial hyperplasia, dysfunctional uterine bleeding, or cysts)

Locations (38)

Site 3

Tucson, Arizona, United States

Site 5

Los Angeles, California, United States

Site 48

Bethesda, Maryland, United States

Site 47

St Louis, Missouri, United States

Site 7

New York, New York, United States

Site 2

New York, New York, United States

Site 50

Charleston, South Carolina, United States

Site 4

Nashville, Tennessee, United States

Site 1

Houston, Texas, United States

Site 8

Houston, Texas, United States

Key Dates

Start Date

November 30, 2018

Primary Completion Date

April 26, 2022

Completion Date

December 22, 2022

Last Updated

August 9, 2024

Enrollment

181

ACTUAL participants

Conditions

Breast Cancer

Interventions

ZN-c5

DRUG

Palbociclib

DRUG

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

View study

RECRUITINGNA

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

NCT05245812

Breast CancerHigh Risk of Breast Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 9, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of ZN-c5 in Subjects With Breast Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer