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NCT07492641 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by BeOne Medicines.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,056
- Enrollment target
NCT07492641: Recruiting Phase 3 study, sponsored by BeOne Medicines.
NCT07492641 is a Phase 3 study that is actively recruiting participants, run by BeOne Medicines. The registered enrollment target is 1,056 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07492641, a Phase 3 study, is actively recruiting participants, sponsored by BeOne Medicines.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,056 participants
- Enrollment target
Study 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.
Primary Outcome
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Interventions
- DRUG Letrozole
- DRUG Palbociclib
- DRUG Abemaciclib
- DRUG Ribociclib
- DRUG BGB-43395
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,056 participants |
| Start Date | 2026-05-22 |
| Est. Completion | 2037-08-07 |
| Phase | Phase 3 |
What NCT07492641 shows while recruiting
NCT07492641 is an interventional study that assigns participants to a tested intervention. Its 1,056 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 5 interventions - of which Letrozole is the first listed.
NCT07492641 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07492641 about?
NCT07492641 is a clinical study titled "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". 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+)/...
What is the current status of trial NCT07492641?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,056 participants. The study started on 2026-05-22. Estimated completion is 2037-08-07.
What interventions are being tested in trial NCT07492641?
The interventions under investigation include: Letrozole (DRUG), Palbociclib (DRUG), Abemaciclib (DRUG), Ribociclib (DRUG), BGB-43395 (DRUG).
Who is sponsoring clinical trial NCT07492641?
This trial is sponsored by BeOne Medicines, which has 29 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07492641's enrollment target sits among peer trials
1,056 277th of 2000 higher than 1,724 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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