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Association details:
| Biomarker: | ER Y537S |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | H3B-6545 (Selective estrogen receptor α inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
Excerpt:
...Participants under amendment 6 (or subsequent amendments) must have ESR1 Y537S mutation in absence of ESR1 D538G mutation as per the results of a central laboratory from a Nucleic Acids Whole Blood sample....
Trial ID:
Source:
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.
Source:
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. Clinical activity was observed in pts with ESR1 mutations.
DOI:
10.1200/JCO.2021.39.15_suppl.1018
Trial ID:
Source:
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
