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    Association details:
    Biomarker:ER positive
    Cancer:HER2 Negative Breast Cancer
    Drug:H3B-6545 (Selective estrogen receptor α inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Go to data
    Source:
    clinicaltrials.gov
    Title:

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

    Excerpt:
    ...ER-positive, HER2-negative breast cancer that is advanced or metastatic....
    Trial ID:
    H3B-6545-A001-101
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

    Excerpt:
    ...Participant has a histologically and/or cytologically confirmed diagnosis of ER-positive, HER2-negative breast cancer....
    Trial ID:
    NCT04568902
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ESMO Asia 2023
    Title:

    55O - Phase I study of H3B-6545 in patients (pts) with estrogen receptor-positive (ER+) breast cancer

    Published date:
    11/27/2023
    Excerpt:
    H3B-6545 450 mg QD had a manageable safety profile and showed preliminary antitumor effect in pts with heavily pretreated, ER+, HER2-negative mBC.
    Trial ID:
    NCT04568902
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    SABCS 2021
    Title:

    H3B-6545, a novel selective estrogen receptor covalent antagonist (SERCA), in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer - A phase II study

    Published date:
    10/09/2021
    Excerpt:
    H3B-6545 has a manageable safety profile and demonstrated single-agent anti-tumor activity in heavily pretreated ER+, HER2- mBC patients. Numerically higher response rate and longer PFS were observed in pts with ESR1 Y537s.
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2021
    Title:

    Phase I/II study of H3B-6545, a novel selective estrogen receptor covalent antagonist (SERCA), in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.

    Published date:
    05/19/2021
    Excerpt:
    H3B-6545 has a manageable safety profile and demonstrated single-agent anti-tumor activity in heavily pretreated ER+, HER2- mBC patients.
    DOI:
    10.1200/JCO.2021.39.15_suppl.1018
    Trial ID:
    H3B-6545-A001-101
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    SABCS 2020
    Title:

    Phase I/II trial of H3B-6545, a novel selective estrogen receptor covalent antagonist (SERCA), in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer

    Published date:
    11/17/2020
    Excerpt:
    H3B-6545 has a manageable safety profile and demonstrated single-agent anti-tumor activity in heavily pretreated ER+, HER2- mBC patients including those with a constitutively active clonal ESR1 Y537S mutation...