BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer
NCT ID: NCT06756932
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
120 participants
INTERVENTIONAL
2025-02-04
2027-07-30
Brief Summary
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Detailed Description
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HR+/HER2- tumors account for approximately 70% of all breast cancers and are responsible for most breast cancer-related deaths. While CDK4/6 inhibitors combined with endocrine therapy have improved outcomes for patients with HR+/HER2- metastatic breast cancer, patients eventually develop progressive disease on these therapies and require new treatments.
BGB-21447 is an oral drug that is highly potent and selectively stops a protein called B-cell lymphoma-2 (Bcl-2). Bcl-2 proteins are often overexpressed in some cancers (like HR+ breast cancer) by keeping the cancer cells from dying. Disrupting this pathway is believed to lead to cell death.
BGB-43395 is an oral drug that selectively stops a protein called cyclin-dependent kinase 4 (CDK4). CDK4 is a type of protein that regulates cell growth and division in your body.
Fulvestrant is a treatment that blocks estrogen receptors and reduces estrogen production. Fulvestrant has been approved to treat hormone receptor positive metastatic breast cancer to help stop the cancer cells from growing.
This combination might be a good way to fight cancer, aiming to give patients the best possible treatment. The study is designed to see if this combination is safe and works well.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1A: BGB-21447 + Fulvestrant
Sequential cohorts of increasing dose levels of BGB-21447 will be evaluated in combination with fulvestrant.
BGB-21447
Administered orally.
Fulvestrant
Administered via intramuscular injection.
Part 1B: BGB-21447 + BGB-43395 + Fulvestrant
Sequential cohorts of increasing dose levels of BGB-21447 will be evaluated in combination with fulvestrant and BGB-43395.
BGB-21447
Administered orally.
Fulvestrant
Administered via intramuscular injection.
BGB-43395
Administered orally.
BGB-21447 + Fulvestrant Food Effect Substudy
Participants will receive BGB-21447 at the recommended dose with a high-fat meal and under a fasted state in combination with fulvestrant.
BGB-21447
Administered orally.
Fulvestrant
Administered via intramuscular injection.
Part 2: Dose Expansion, BGB-21447 + Fulvestrant
Participants will receive BGB-21447 at the recommended dose(s) for expansion determined in Part 1A in combination with fulvestrant.
BGB-21447
Administered orally.
Fulvestrant
Administered via intramuscular injection.
Interventions
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BGB-21447
Administered orally.
Fulvestrant
Administered via intramuscular injection.
BGB-43395
Administered orally.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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BeOne Medicines
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeOne Medicines
Locations
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Hoag Memorial Presbyterian
Newport Beach, California, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Md Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Saint Vincents Hospital Sydney
Darlinghurst, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Sunshine Coast University Private Hospital
Birtinya, Queensland, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Western Health Sunshine Hospital
St Albans, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
Fudan University Shanghai Cancer Centerpudong
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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CTR20250114
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-21447-102
Identifier Type: -
Identifier Source: org_study_id