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NCT04288089 · ClinicalTrials.gov registry record · Phase 1
A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer
A Phase 1 study of Breast Neoplasms and Receptors, Estrogen, sponsored by Eisai.
- Active
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 8
- Study locations
NCT04288089: Active Phase 1 study of Breast Neoplasms and Receptors, Estrogen, sponsored by Eisai.
NCT04288089 is a Phase 1 study of Breast Neoplasms and Receptors, Estrogen that is active but no longer recruiting, run by Eisai. The registered enrollment target is 31 participants, below the 569-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (95% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04288089, a Phase 1 study of Breast Neoplasms and Receptors, Estrogen, is active but no longer recruiting, sponsored by Eisai.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 8
- Study locations
Study Summary
The primary objective of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of this combination in women with advanced or metastatic estrogen receptor-positive (ER+) HER2- breast cancer.
Primary Outcome
The MTD was defined as the highest dose at which no more than 1 of 6 participants experienced a Dose-Limiting Toxicity (DLT) in the dose cohort. DLT was graded as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. 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 thr
Conditions Studied
Interventions
- DRUG Palbociclib (75, 100, 125 milligram [mg])
- DRUG H3B-6545 (150, 300, 450 mg)
Study Locations (8)
Other
- Royal Marsden NHS Foundation Trust - London
- Sarah Cannon Research Institute UK - SCRI - London
- Royal Marsden NHS Foundation Trust - Sutton
Florida
- Florida Cancer Specialists South - SCRI - PPDS - Sarasota
Massachusetts
- Massachusetts General Hospital - Boston
Missouri
- Saint Luke's Cancer Institute - Kansas City
Nevada
- Comprehensive Cancer Centers of Nevada - Las Vegas
Tennessee
- Tennessee Oncology, PLLC - SCRI - PPDS - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2020-04-01 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 1 |
What the registry record for NCT04288089 still lists
NCT04288089 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 569-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Breast Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Palbociclib (75, 100, 125 milligram [mg]) is the first listed.
NCT04288089 lists 8 locations in 6 states (Other, Florida, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT04288089 about?
NCT04288089 is a clinical study titled "A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer". The primary objective of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of this combination in women with advanced or metastatic estro...
What is the current status of trial NCT04288089?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2020-04-01. Estimated completion is 2027-03-31.
What conditions does trial NCT04288089 study?
This clinical trial studies the following conditions: Breast Neoplasms, Receptors, Estrogen, Genes, Erbb-2.
What interventions are being tested in trial NCT04288089?
The interventions under investigation include: Palbociclib (75, 100, 125 milligram [mg]) (DRUG), H3B-6545 (150, 300, 450 mg) (DRUG).
Who is sponsoring clinical trial NCT04288089?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04288089 being conducted?
This trial has 8 study locations across Florida, Massachusetts, Missouri, Nevada, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04288089's enrollment target sits among peer trials
31 85th of 97 higher than 12 of 97 other Breast Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Neoplasms 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.
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