Last updated on September 2020

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

Brief description of study

The purpose of phase 1 is to determine safety, tolerability and pharmacokinetics (PK) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer.

The purpose of phase 2 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].

Clinical Study Identifier: NCT03250676

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Holy Cross Hospital Inc

Fort Lauderdale, FL United States
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Florida Cancer Specialists North

Saint Petersburg, FL United States
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Carle Cancer Center

Urbana, IL United States
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University of Michigan

Ann Arbor, MI United States
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Saint Luke's Cancer Institute

Kansas City, MO United States
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Research Medical Center

Kansas City, MO United States
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University of North Carolina

Chapel Hill, NC United States
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Tennessee Oncology

Nashville, TN United States
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Velindre Cancer Centre

Cardiff, United Kingdom
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Barts Health NHS Trust

London, United Kingdom
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Christie Hospital

Manchester, United Kingdom
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Recruitment Status: Open

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