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NCT03250676 · ClinicalTrials.gov registry record · Phase 1
Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
A Phase 1 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 151
- Enrollment target
NCT03250676 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 151 participants.
The verdict
NCT03250676, a Phase 1 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 151 participants
- Enrollment target
Study Summary
The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer. The primary purpose of phase 2 portion of this study 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).
Interventions
- DRUG H3B-6545
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2017-08-23 |
| Est. Completion | 2023-10-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03250676
The ClinicalTrials.gov registry entry for NCT03250676 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which H3B-6545 is the first listed.
NCT03250676 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03250676 about?
NCT03250676 is a clinical study titled "Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer". The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer. The prim...
What is the current status of trial NCT03250676?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 151 participants. The study started on 2017-08-23. Estimated completion is 2023-10-26.
What interventions are being tested in trial NCT03250676?
The interventions under investigation include: H3B-6545 (DRUG).
Who is sponsoring clinical trial NCT03250676?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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