Eisai Clinical Trials

A Phase 1-2 Multicenter, Open Label Trial of H3B-6545, a Covalent Antagonist of Estrogen Receptor Alpha, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer

H3B-6545-A001-101

Study Overview

H3B-6545
H3B-6545
NCT03250676, 2018-000570-29
Aug 2017 - Oct 2023
Breast Cancer
1. Number of Participants with Dose-limiting Toxicities (DLTs) [Time Frame: Phase 1 Cycle 1 (28 days)]

2. Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time Frame: Phase 1 and 2 continuously throughout the study until 28 days after treatment discontinuation (up to 36 months)]

  • Females 18 Years and older (Adult, Older Adult)

  • Completed

  • Phase 1 / 2

  • France, United Kingdom, United States See more

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Furman C, Puyang X, Zhang Z, Wu ZJ, Banka D, Aithal KB, Albacker LA, Hao MH, Irwin S, Kim A, Montesion M, Moriarty AD, Murugesan K, Nguyen TV, Rimkunas V, Sahmoud T, Wick MJ, Yao S, Zhang X, Zeng H, Vaillancourt FH, Bolduc DM, Larsen N, Zheng GZ, Prajapati S, Zhu P, Korpal M. Covalent ERalpha Antagonist H3B-6545 Demonstrates Encouraging Preclinical Activity in Therapy-Resistant Breast Cancer. Mol Cancer Ther. 2022 Jun 1;21(6):890-902. doi: 10.1158/1535-7163.MCT-21-0378.

Data Sharing

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CSDR Sharing is not available for this study.

CSDR Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type Availability
Protocol
SAP
Sample CRF
Full CSR