BGB-21447 Combinations for Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you must not have had prior exposure to Bcl-2 inhibitors, and you may need to continue or start ovarian function suppression if you are a female participant.
What data supports the effectiveness of the drug BGB-21447 for breast cancer?
The research on similar drugs like alpelisib (BYL-719) shows that it can be effective in treating certain types of breast cancer, especially when combined with other treatments. Alpelisib has been approved for use with fulvestrant in hormone receptor-positive breast cancer, suggesting that drugs targeting similar pathways may also be effective.12345
Is BGB-21447 safe for use in humans?
What is the purpose of this trial?
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.
Research Team
Study Director
Principal Investigator
BeiGene
Eligibility Criteria
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.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BGB-21447 in combination with fulvestrant, with or without BGB-43395, to assess safety and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for long-term outcomes such as Objective Response Rate and Duration of Response
Treatment Details
Interventions
- BGB-21447
- BGB-43395
Find a Clinic Near You
Who Is Running the Clinical Trial?
BeiGene
Lead Sponsor