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
← catalyst calendarNCT07492641 · readout ≤ 985 d
Sponsored by BeOne Medicines (industry) · ONC — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
1,056estimated
Sites
108
Countries
Australia, Brazil, China +7
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-05-22 | actual | When the study began enrolling |
| Primary completion | Apr 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2037-08-07 | estimated | The whole study's end, after follow-up |
| First posted | 2026-03-25 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- HR+/HER2- Breast Cancer
Interventions
- Drug: BGB-43395
- Drug: Letrozole
- Drug: Abemaciclib
- Drug: Palbociclib
- Drug: Ribociclib
Primary outcome
what the primary-completion date above is the date OFProgression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)
measured Up to approximately 4 years
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