NCT03250676

Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer. The primary purpose of phase 2 portion of this study is to estimate the efficacy of H3B-6545 in terms of best overall response rate, duration of response (DoR), clinical benefit rate (CBR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) in all participants with ER-positive, HER2-negative breast cancer and in those with and without ER alpha mutation (including a clonal estrogen receptor 1 gene \[ESR1\] Y537S mutation).

Conditions

• Breast Neoplasms
• Breast Cancer
• Estrogen-receptor Positive Breast Cancer
• Cancer, Breast
• Breast Cancer Female
• Breast Adenocarcinoma
• Estrogen Receptor Positive Tumor
• ER Positive

Interventions

Type	Name	Description
DRUG	H3B-6545	Oral capsules by mouth once daily

Timeline

• Start date: 2017-08-23
• Primary completion: 2023-10-26
• Completion: 2023-10-26
• First posted: 2017-08-16
• Last updated: 2025-02-25
• Results posted: 2025-02-25

Locations

39 sites across 3 countries: United States, France, United Kingdom

Regulatory

• FDA-regulated drug study