Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
Status:
Recruiting
Trial end date:
2022-09-30
Target enrollment:
Participant gender:
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).