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

  • STATUS
    Recruiting
  • End date
    Jan 31, 2024
  • participants needed
    148
  • sponsor
    H3 Biomedicine Inc.
Updated on 25 January 2021
cancer
estrogen
measurable disease
breast cancer
growth factor
HER2
human epidermal growth factor
erbb2
epidermal growth factor
estrogen receptor
ESR1
her2/neu-negative breast cancer

Summary

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].

Details
Condition Breast Cancer, Estrogen Receptor Positive Breast Cancer, Breast Cancer Female, Breast Cancer Diagnosis, ER Positive, Adenocarcinoma of the Breast, Breast Adenocarcinoma, ER+ Breast Cancer, Estrogen Receptor Positive Tumor, breast carcinoma, estrogen receptor-positive breast cancer, cancer, breast, breast tumors, tumor of the breast, breast tumor
Treatment H3B-6545
Clinical Study IdentifierNCT03250676
SponsorH3 Biomedicine Inc.
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have any of these conditions: Estrogen Receptor Positive Tumor or Breast Cancer or ER Positive or Breast Cancer Female or Estrogen Receptor Positive Breast Cancer or Breast Adenoca...?
Do you have any of these conditions: cancer, breast or Breast Adenocarcinoma or estrogen receptor-positive breast cancer or breast tumors or Breast Cancer Female or ER+ Breast Cancer or E...?
Pre- or post-menopausal women
ER-positive, HER2-negative breast cancer that is advanced or metastatic
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
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
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Adequate bone marrow and organ function
Participants under amendment 6 must have measurable disease at baseline as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
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

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