Trial intelligence / Profile preview

ZN-c5 Monotherapy and Combination with Palbociclib in Advanced ER+/HER2- Breast Cancer

NCT03560531Phase 2

Key facts

Status: Completed
Start: Nov 2018
Primary completion: Apr 2022
Countries: 9
Sponsor: Zeno Alpha, Inc.
Modality: Small Molecules

Drugs: ZN-c5
Conditions: breast cancer

Overview

Phase 2, open-label trial of ZN-c5 in breast cancer (2 arms), sponsored by Zeno Alpha, Inc. Primary endpoints: Clinical Benefit Rate at 24 weeks and Best Overall Response at 24 weeks. Started Nov 2018; status: completed.

Design

2 arms

Study design: Non-randomizedOpen-label

ZN-c5 Monotherapy
ZN-c5 administered orally (Escalation + Expansion)
ZN-c5 + Palbociclib
ZN-c5 + Palbociclib administered orally (Escalation + Phase 2)

Who it enrols

Adult women with histologically confirmed ER+/HER2- advanced adenocarcinoma of the breast who have progressed on prior endocrine therapy.

Endpoints

Primary

Clinical Benefit Rate24 weeks
Best Overall Response24 weeks

Secondary

Progression-Free Survival12 months
Overall Survival12 months
Objective Response Rate24 weeks

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