Last updated on September 2020

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast Cancer | ER Positive | Breast Adenocarcinoma | Estrogen Receptor Positive Breast Cancer | Estrogen Receptor Positive Tumor | Breast Cancer Female
  • Age: Between 18 - 100 Years
  • Gender: Female

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. Participants under amendment 6 must have received prior cyclin-dependent kinase (CDK4/6) inhibitor therapy.
  4. A recent archival tumor tissue obtained within 6 months prior to enrollment or a fresh tumor biopsy must be provided. A second biopsy after initiating trial therapy is not required.
  5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  6. Adequate bone marrow and organ function.
  7. Participants under amendment 6 must have measurable disease at baseline as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
  8. Participants under amendment 6 must have ESR1 Y537S mutation in absence of ESR1 D538G mutation as per the results of a central laboratory.

Exclusion Criteria:

  1. Participants must have at least one measurable lesion.
  2. Participant with inflammatory breast cancer.
  3. Participant has received more than one prior chemotherapy regimen for metastatic disease (Phase 2 only).
  4. Females of childbearing potential who are unable or unwilling to follow adequate contraceptive measures.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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