Trial of H3B-6545 in Women With Locally Advanced or Metastatic Estrogen Receptor-positive HER2 Negative Breast Cancer
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- STATUS
- Recruiting
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- End date
- Jan 31, 2024
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- participants needed
- 148
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- sponsor
- H3 Biomedicine Inc.
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 |
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| Treatment | H3B-6545 |
| Clinical Study Identifier | NCT03250676 |
| Sponsor | H3 Biomedicine Inc. |
| Last Modified on | 25 January 2021 |
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