NCT07492641 BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease
| NCT ID | NCT07492641 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | BeOne Medicines |
| Condition | HR+/HER2- Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,056 participants |
| Start Date | 2026-05-20 |
| Primary Completion | 2029-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,056 participants in total. It began in 2026-05-20 with a primary completion date of 2029-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole in patients with advanced or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) who have not received prior systemic treatment for advanced or metastatic disease.
Eligibility Criteria
Inclusion Criteria: * Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent. * Participants with histologically confirmed locally advanced or metastatic HR+ HER2- breast cancer. * Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1. * Adequate organ function. Exclusion Criteria: * Participants who have received prior systemic treatment in the advanced or metastatic setting. * Participants who have received prior treatment with any selective cyclin-dependent kinase 4 (CDK4) or cyclin-dependent kinase 2 (CDK2) targeting agent, or any other investigational anticancer drug in any disease setting, except for prior investigational or approved SERDs in the adjuvant setting, provided that disease recurrence occurred more than 12 months after the last dose of endocrine-based therapy. * Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis. Note: Other protocol-defined inclusion/exclusion criteria may apply.
Contact & Investigator
Study Director
STUDY DIRECTOR
BeOne Medicines
Frequently Asked Questions
Who can join the NCT07492641 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HR+/HER2- Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07492641 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,056 participants.
Is NCT07492641 currently recruiting?
Yes, NCT07492641 is actively recruiting participants. Contact the research team at clinicaltrials@beonemed.com for enrollment information.
Where is the NCT07492641 trial being conducted?
This trial is being conducted at Anchorage, United States, O'Fallon, United States, Omaha, United States, East Brunswick, United States and 9 additional locations.
Who is sponsoring the NCT07492641 clinical trial?
NCT07492641 is sponsored by BeOne Medicines. The principal investigator is Study Director at BeOne Medicines. The trial plans to enroll 1,056 participants.
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