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New combo drug trial hopes to tame tough breast cancer

NCT ID NCT04288089

Disease control Sponsor: Eisai Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This early-stage study tests a new drug (H3B-6545) combined with an existing drug (palbociclib) in women with advanced or metastatic ER+ HER2- breast cancer. The main goal is to find the safest dose and understand side effects. About 31 women who have already tried other treatments will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

31 people

The number who actually took part.

Started

Apr 2020

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. ER+ HER2- locally advanced, recurrent, or metastatic breast cancer, as per local laboratory 2. Prior therapy in the advanced/metastatic setting 3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Has adequate bone marrow and organ function Exclusion Criteria: 1. Uncontrolled significant active infections 2. Major surgery or other locoregional treatment within 4 weeks before the 1st dose of study drug 3. Inability to take oral medication or presence of malabsorption 4. Active cardiac disease or a history of cardiac dysfunction 5. Evidence of ongoing Alcohol or Drug Abuse

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Conditions

The condition(s) this trial relates to.

breast neoplasm estrogen-receptor positive breast cancer hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast neoplasms Genes, ERBB-2 Receptors, estrogen

Contacts and locations

Locations

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169, United States

  • Florida Cancer Specialists South - SCRI - PPDS

    Sarasota, Florida, 34232, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Royal Marsden NHS Foundation Trust

    London, United Kingdom

  • Royal Marsden NHS Foundation Trust

    Sutton, United Kingdom

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64111, United States

  • Sarah Cannon Research Institute UK - SCRI

    London, United Kingdom

  • Tennessee Oncology, PLLC - SCRI - PPDS

    Nashville, Tennessee, 37203, United States

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