Fort Lauderdale, Florida 33308

  • ER Positive


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-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 response rate, duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).


Inclusion Criteria: 1. Pre- or post-menopausal women. 2. ER-positive, HER2-negative breast cancer that is advanced or metastatic. 3. Progressed on prior therapy. Multiple prior lines of therapy allowed in Phase 1 and 2. 4. Must be willing to undergo a biopsy prior to treatment and on Cycle 2 Day 1. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 6. Adequate bone marrow and organ function. Exclusion Criteria: 1. Participant with bone-only disease (Phase I only). Note: Phase II subjects may have predominantly lytic bone only disease. 2. Participant with inflammatory breast cancer. 3. Participant has received more than one prior chemotherapy regimen for metastatic disease (Phase II only). 4. Females of childbearing potential who are unable or unwilling to follow adequate contraceptive measures.



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Fort Lauderdale, Florida 33308
United States

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Site Status: N/A

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Date Processed: March 30, 2020

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