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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06756932
Registration number
NCT06756932
Ethics application status
Date submitted
24/12/2024
Date registered
3/01/2025
Date last updated
11/07/2025
Titles & IDs
Public 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
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Scientific title
A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-21447 (a Bcl-2 Inhibitor) Combinations for Patients With HR+/HER2- Metastatic Breast Cancer
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Secondary ID [1]
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CTR20250114
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Secondary ID [2]
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BGB-21447-102
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hormone-receptor-positive Breast Cancer
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HER2-negative Breast Cancer
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Metastatic Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BGB-21447
Treatment: Drugs - Fulvestrant
Treatment: Drugs - BGB-43395
Experimental: Part A: BGB-21447 + Fulvestrant - Sequential cohorts of increasing dose levels of BGB-21447 will be evaluated in combination with fulvestrant.
Experimental: Part B: BGB-21447 + BGB-43395 + Fulvestrant - Sequential cohorts of increasing dose levels of BGB-21447 will be evaluated in combination with fulvestrant and BGB-43395.
Experimental: BGB-21447 Food Effect Substudy - Participants will receive BGB-21447 at the recommended dose with a high-fat meal and under a fasted state.
Treatment: Drugs: BGB-21447
Administered orally.
Treatment: Drugs: Fulvestrant
Administered via intramuscular injection.
Treatment: Drugs: BGB-43395
Administered orally.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [1]
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Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and AEs that meet protocol-defined dose-limiting toxicity criteria.
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Timepoint [1]
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From the first dose of study drug(s) to 30 days after the last dose; up to approximately 6 months
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Primary outcome [2]
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Recommended Dose for Expansion (RDFE) of BGB-21447 in combination with fulvestrant and in combination with fulvestrant and BGB-43395
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Assessment method [2]
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RDFE of BGB-21447 in combination with fulvestrant and in combination with fulvestrant and BGB-43395 will be determined based upon the maximum tolerated dose (MTD) or maximum administered dose (MAD).
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Timepoint [2]
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Approximately 6 to 9 months
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Secondary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
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Timepoint [1]
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Approximately 12 months
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Secondary outcome [2]
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Duration of Response (DOR)
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Assessment method [2]
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DOR is defined as the time from the first determination of an objective response until the first documentation of progression or death, whichever comes first, as assessed by the investigator per RECIST v1.1.
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Timepoint [2]
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Approximately 12 months
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Secondary outcome [3]
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Time to Response (TTR)
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Assessment method [3]
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TTR is defined as the time from the date of the first dose of study drug to the date of the first CR or PR, as assessed by the investigator per RECIST v1.1.
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Timepoint [3]
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Approximately 12 months
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Secondary outcome [4]
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Maximum observed plasma concentration (Cmax) of BGB-21447, BGB-43395, and BGB-43395 metabolite
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Assessment method [4]
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Timepoint [4]
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Up to approximately 2 months
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Secondary outcome [5]
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Time to reach maximum observed plasma concentration (Tmax) of BGB-21447, BGB-43395, and BGB-43395 metabolite
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Assessment method [5]
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Timepoint [5]
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Up to approximately 2 months
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Secondary outcome [6]
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Area under the concentration-time curve (AUC) of BGB-21447, BGB-43395, and BGB-43395 metabolite
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Assessment method [6]
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Timepoint [6]
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Up to approximately 2 months
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Secondary outcome [7]
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Apparent terminal elimination half-life (t1/2) of BGB-21447, BGB-43395, and BGB-43395 metabolite
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Assessment method [7]
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Timepoint [7]
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Up to approximately 2 months
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Secondary outcome [8]
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Food Effect Substudy: AUC of BGB-21447 under fasted and fed state
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Assessment method [8]
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Timepoint [8]
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Up to approximately 2 months
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Secondary outcome [9]
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Food Effect Substudy: Cmax of BGB-21447 under fasted and fed state
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Assessment method [9]
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Timepoint [9]
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Up to approximately 2 months
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Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed HR+/HER2- metastatic breast cancer. Participants must have received = 2 prior lines of treatment for 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 90 days after the last dose of BGB-21447, 3 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Prior Bcl-2 inhibitor exposure.
* 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).
* 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/02/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2027
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Actual
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Sample size
Target
92
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Saint Vincents Hospital Sydney - Darlinghurst
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Recruitment hospital [2]
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Calvary Mater Newcastle - Waratah
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Recruitment hospital [3]
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Sunshine Coast University Private Hospital - Birtinya
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Recruitment hospital [4]
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Peter Maccallum Cancer Centre - Melbourne
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Recruitment hospital [5]
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Western Health Sunshine Hospital - St Albans
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Recruitment hospital [6]
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Linear Clinical Research - Nedlands
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2298 - Waratah
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Recruitment postcode(s) [3]
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4575 - Birtinya
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Recruitment postcode(s) [4]
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3000 - Melbourne
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Recruitment postcode(s) [5]
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3021 - St Albans
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Recruitment postcode(s) [6]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Iowa
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Country [3]
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United States of America
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State/province [3]
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Texas
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Country [4]
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United States of America
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State/province [4]
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Washington
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Country [5]
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China
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State/province [5]
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Guangdong
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Country [6]
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China
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State/province [6]
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Henan
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Country [7]
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China
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State/province [7]
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Jiangxi
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Country [8]
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China
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State/province [8]
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Shanghai
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Country [9]
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China
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State/province [9]
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Tianjin
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Country [10]
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China
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State/province [10]
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Zhejiang
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
BeiGene
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is 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.
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Trial website
https://clinicaltrials.gov/study/NCT06756932
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Study Director
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Address
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BeiGene
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Study Director
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Address
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Country
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Phone
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1.877.828.5568
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06756932
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