Actively Recruiting
BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer
Led by BeOne Medicines · Updated on 2025-11-10
120
Participants Needed
16
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a dose escalation and dose expansion study to assess the safety and tolerability of BGB-21447 (a B-cell leukemia/lymphoma 2 inhibitor, Bcl-2i) in combination with fulvestrant, with or without BGB-43395 (cyclin-dependent kinase 4 inhibitor, CDK4i), in adults with HR+/HER2- metastatic breast cancer.
CONDITIONS
Official Title
BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed HR+/HER2- metastatic breast cancer
- Part 1A and 1B: Received at least 1 prior line of treatment for advanced/metastatic disease including endocrine therapy and CDK4/6 inhibitor
- Part 2: Received 1 to 3 prior lines of treatment for advanced/metastatic disease including endocrine therapy and CDK4/6 inhibitor
- Female participants must have ovarian function suppression or be postmenopausal
- Male participants may need to use GnRH agonists when treated with fulvestrant
- Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 1 or less
- Adequate organ function
- Willingness to use effective birth control during the study and specified periods after last dose
- Ability and willingness to fast overnight and consume a high-fat meal (food effect substudy only)
You will not qualify if you...
- Prior exposure to Bcl-2 inhibitors
- For triplet combination cohorts: Prior therapy targeting CDK4
- Known leptomeningeal disease or uncontrolled, untreated brain metastases
- Any malignancy within 3 years before first dose except the study cancer or certain treated local cancers
- Uncontrolled diabetes (Part 1B only)
- History of hepatitis B or active hepatitis C infection
- In China only: Untreated chronic hepatitis B or HBV carriers with high viral load at screening
- Other protocol-defined inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Hoag Memorial Presbyterian
Newport Beach, California, United States, 92663-4162
Actively Recruiting
2
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242-1009
Actively Recruiting
3
Md Anderson Cancer Center
Houston, Texas, United States, 77030-3907
Actively Recruiting
4
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-4433
Actively Recruiting
5
Saint Vincents Hospital Sydney
Darlinghurst, New South Wales, Australia, NSW 2010
Actively Recruiting
6
Calvary Mater Newcastle
Waratah, New South Wales, Australia, NSW 2298
Actively Recruiting
7
Sunshine Coast University Private Hospital
Birtinya, Queensland, Australia, QLD 4575
Actively Recruiting
8
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia, VIC 3000
Actively Recruiting
9
Western Health Sunshine Hospital
St Albans, Victoria, Australia, VIC 3021
Actively Recruiting
10
Linear Clinical Research
Nedlands, Western Australia, Australia, WA 6009
Actively Recruiting
11
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong, China, 510245
Actively Recruiting
12
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
13
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China, 330006
Actively Recruiting
14
Fudan University Shanghai Cancer Centerpudong
Shanghai, Shanghai Municipality, China, 201321
Actively Recruiting
15
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
16
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310016
Actively Recruiting
Research Team
S
Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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