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New drug cocktail aims to shrink Hard-to-Treat breast cancer

NCT ID NCT06756932

Disease control Sponsor: BeOne Medicines Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

This early-phase trial is testing a new drug called BGB-21447, which blocks a protein that helps cancer cells survive. It is given together with standard hormone therapy (fulvestrant) and sometimes another targeted drug (BGB-43395). The study involves 120 adults with HR+/HER2- metastatic breast cancer whose disease has progressed after prior treatments. The main goals are to check safety and find the best dose, while also seeing if the tumors shrink.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BGB-21447 (a Bcl-2 inhibitor) combined with fulvestrant and/or BGB-43395 (a CDK4 inhibitor)
What this could lead to
If successful, this could lead to a new treatment option for people with HR+/HER2- metastatic breast cancer that has stopped responding to standard therapies.
What could go wrong
This is an early Phase 1 trial with only 120 participants, focused on safety and dosing. It is too small and early to know if the combination will work or be safe long-term.

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

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Jul 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

Anyone

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: * Histologically or cytologically confirmed HR+/HER2- metastatic breast cancer. Part 1A and 1B: Participants must have received ≥ 1 prior line(s) of treatment for advanced/metastatic disease, including prior endocrine therapy and CDK4/6 inhibitor in either the adjuvant or advanced/metastatic setting. Part 2: Participants must have received 1-3 prior line(s) of treatment for advanced/metastatic disease, including prior endocrine therapy and CDK4/6 inhibitor in either the adjuvant or advanced/metastatic setting. * Female participants will be required (either continue ongoing or initiate as soon as feasible) to have ovarian function suppression using gonadotropin-releasing hormone (GnRH) agonists (such as goserelin) or be postmenopausal. * Male participants may be required to use GnRH agonists when being treated with fulvestrant at the discretion of the investigator. * Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1. * Adequate organ function. * Female participants of childbearing potential and nonsterile male participants with female partners of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and for 7 days after the last dose of BGB-21447, 6 months after the last dose of BGB-43395, and 2 years after the last dose of fulvestrant. * Food effect substudy only: Participants who are able and willing to fast overnight (≥ 10 hours) and consume a high-fat meal. Exclusion Criteria: * Prior Bcl-2 inhibitor exposure. For triplet combination cohorts only: Prior therapy selectively targeting CDK4. * Known leptomeningeal disease or uncontrolled, untreated brain metastases. * Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, treated papillary thyroid carcinoma, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast). * For Part 1B: Uncontrolled diabetes. * History of hepatitis B or active Hepatitis C infection * China Only: Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA \> 500 IU/ml (or \> 2500 copies/ml) at screening. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm Her2-receptor negative breast cancer hormone receptor-positive breast cancer

As listed by the trial registrant

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

HER2-negative breast cancer Hormone receptor-positive breast cancer Metastatic breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    13 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Calvary Mater Newcastle

    RECRUITING

    Waratah, New South Wales, NSW 2298, Australia

  • Fred Hutchinson Cancer Research Center

    RECRUITING

    Seattle, Washington, 98109-4433, United States

  • Fudan University Shanghai Cancer Centerpudong

    RECRUITING

    Shanghai, Shanghai Municipality, 201321, China

  • Linear Clinical Research

    RECRUITING

    Nedlands, Western Australia, WA 6009, Australia

  • Md Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030-3907, United States

  • Peter Maccallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, VIC 3000, Australia

  • Saint Vincents Hospital Sydney

    TERMINATED

    Darlinghurst, New South Wales, NSW 2010, Australia

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310016, China

  • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)

    RECRUITING

    Guangzhou, Guangdong, 510245, China

  • Sunshine Coast University Private Hospital

    RECRUITING

    Birtinya, Queensland, QLD 4575, Australia

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

  • Tianjin Medical University Cancer Institute and Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300060, China

  • University of Iowa Hospitals and Clinics

    RECRUITING

    Iowa City, Iowa, 52242-1009, United States

  • Western Health Sunshine Hospital

    RECRUITING

    St Albans, Victoria, VIC 3021, Australia

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