Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE3 | RECRUITING | 1,056 | — | — | May 20, 2026 | Aug 7, 2037 | Jun 3, 2026 | 13 | United States, Australia +2 |
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.
| Arm | Type | Description |
|---|---|---|
| Arm A: BGB-43395 + Letrozole | EXPERIMENTAL | Participants will receive BGB-43395 in combination with letrozole. |
| Arm B: Cyclin-Dependent Kinase 4/6 Inhibitor + Letrozole | ACTIVE_COMPARATOR | Participants will receive either abemaciclib, palbociclib, or ribociclib based on the Investigator's choice in combination with letrozole. |
| Name | Type | Description |
|---|---|---|
| BGB-43395 | DRUG | Administered orally. |
| Letrozole | DRUG | Administered orally. |
| Abemaciclib | DRUG | Administered orally. |
| Palbociclib | DRUG | Administered orally. |
| Ribociclib | DRUG | Administered orally. |
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. * ...