Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Conditions Studied

Breast Neoplasms Receptors, Estrogen Genes, Erbb-2

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

FieldValue
Enrollment Target 31 participants
Start Date 2020-04-01
Est. Completion 2027-03-31
Phase Phase 1

Sponsor

Eisai

287 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04288089

The ClinicalTrials.gov registry entry for NCT04288089 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 569-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (95% lower). The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.

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 reports 8 study locations spanning 6 distinct geographic areas - top geographies include 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.

Explore more on PlainTrial

Breast Neoplasms

All registered trials for this condition

Receptors, Estrogen

All registered trials for this condition

Florida

All trials with a study site in Florida

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.