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

  • STATUS
    Not Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    170
  • sponsor
    H3 Biomedicine Inc.
Updated on 13 June 2022
cancer
estrogen
measurable disease
breast cancer
growth factor
HER2
human epidermal growth factor
erbb2
epidermal growth factor
estrogen receptor
ESR1
her2/neu-negative breast cancer

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).

Details
Condition Breast Neoplasms, Breast Cancer, Estrogen-receptor Positive Breast Cancer, Cancer, Breast, Breast Cancer Female, Breast Adenocarcinoma, Estrogen Receptor Positive Tumor, ER Positive
Treatment H3B-6545
Clinical Study IdentifierNCT03250676
SponsorH3 Biomedicine Inc.
Last Modified on13 June 2022

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