ClinicalTrials.gov record
Active, not recruiting Phase 1 Interventional Results available

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

ClinicalTrials.gov ID: NCT04288089

Public ClinicalTrials.gov record NCT04288089. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 8, 2026, 8:09 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label Multicenter Phase 1b Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive HER2-Negative Breast Cancer

Study identification

NCT ID
NCT04288089
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Eisai Inc.
Industry
Enrollment
31 participants

Conditions and interventions

Interventions

  • H3B-6545 (150, 300, 450 mg) Drug
  • Palbociclib (75, 100, 125 milligram [mg]) Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2020
Primary completion
Sep 15, 2022
Completion
Mar 30, 2027
Last update posted
Feb 26, 2026

2020 – 2027

United States locations

U.S. sites
5
U.S. states
5
U.S. cities
5
Facility City State ZIP Site status
Florida Cancer Specialists South - SCRI - PPDS Sarasota Florida 34232
Massachusetts General Hospital Boston Massachusetts 02114
Saint Luke's Cancer Institute Kansas City Missouri 64111
Comprehensive Cancer Centers of Nevada Las Vegas Nevada 89169
Tennessee Oncology, PLLC - SCRI - PPDS Nashville Tennessee 37203

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04288089, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 26, 2026 · Synced May 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04288089 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →