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Bcl-2 Inhibitor

BGB-21447 Combinations for Breast Cancer

Newport, CA
Phase 1
Recruiting
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Histologically or cytologically confirmed HR+/HER2- metastatic breast cancer. Participants must have received at least 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 with metastatic breast cancer will be required (either continue ongoing or initiate as soon as feasible) to have ovarian function suppression using GnRH agonists (such as goserelin) or be postmenopausal.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 6 to 9 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test the safety and side effects of a drug called BGB-21447, used alongside fulvestrant, with or without another drug called BGB-43395, in adults

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Who is the study for?
Adults with HR+/HER2- metastatic breast cancer who've had at least two prior treatments, including endocrine therapy and CDK4/6 inhibitors. Women must manage ovarian function suppression; men may need GnRH agonists. Participants should be relatively healthy (ECOG ≤ 1) and willing to use effective birth control during the study.Check my eligibility
What is being tested?
The trial is testing BGB-21447, a drug aimed at blocking a protein that helps cancer cells survive, combined with fulvestrant. It's also looking at adding another drug, BGB-43395, which inhibits enzymes involved in cell division. The goal is to see if these combinations are safe for patients.See study design
What are the potential side effects?
Potential side effects include typical reactions to cancer medications such as nausea, fatigue, blood count changes leading to increased infection risk or bleeding problems, liver enzyme alterations indicating potential liver damage, and possible hormonal imbalances due to the therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is HR+/HER2- and I've had at least 2 treatments for it, including hormone therapy and a CDK4/6 inhibitor.
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I am a woman with breast cancer and will start or continue ovarian suppression.
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I can carry out all my self-care but can't do heavy physical work.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6 to 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6 to 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Recommended Dose for Expansion (RDFE) of BGB-21447 in combination with fulvestrant and in combination with fulvestrant and BGB-43395
Secondary study objectives
Duration of Response (DOR)
Objective Response Rate (ORR)
Time to Response (TTR)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B: BGB-21447 + BGB-43395 + FulvestrantExperimental Treatment3 Interventions
Sequential cohorts of increasing dose levels of BGB-21447 will be evaluated in combination with fulvestrant and BGB-43395.
Group II: Part A: BGB-21447 + FulvestrantExperimental Treatment2 Interventions
Sequential cohorts of increasing dose levels of BGB-21447 will be evaluated in combination with fulvestrant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~4160

Find a Location

Closest Location:University of Iowa Hospitals and Clinics· Iowa City, IA· 462 miles

Who is running the clinical trial?

BeiGeneLead Sponsor
215 Previous Clinical Trials
32,316 Total Patients Enrolled
3 Trials studying Breast Cancer
287 Patients Enrolled for Breast Cancer
Study DirectorStudy DirectorBeiGene
1,315 Previous Clinical Trials
573,018 Total Patients Enrolled
28 Trials studying Breast Cancer
8,902 Patients Enrolled for Breast Cancer
~61 spots leftby Jun 2027
Unbiased ResultsWe believe in providing patients with all the options.
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