Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Eisai.
NCT03250676 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 151 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (152% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
DLT was graded as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. DLTs were defined as the following events that occurred in Cycle 1, for which a causal relationship with the study drug could not be ruled out: febrile neutropenia; Grade 4 neutropenia that was not resolved within 7 days; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia lasting greater than (\>) 7 days or associated with clinically significant bleeding; Grade 4 vomiting an
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 |
What the finished NCT03250676 record still lists
NCT03250676 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (152% higher).
The record links to 0 conditions, and to 1 intervention - of which H3B-6545 is the first listed.
NCT03250676 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03250676's enrollment target sits among peer trials
151 363rd of 2000 higher than 1,638 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01409161 · 151 participants · Phase 2
Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
- NCT04245397 · 151 participants · Phase 1
Study of SX-682 Alone and in Combination With Oral or Intravenous Decitabine in Subjects With Myelodysplastic Syndrome
- NCT05761223 · 151 participants · Phase 1
A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849
- NCT07195656 · 151 participants · NA
Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI