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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06265428 | A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 228 | — | — | Jan 29, 2024 | Feb 1, 2026 | Oct 20, 2025 | 48 | China |
Defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first
| Arm | Type | Description |
|---|---|---|
| DB-1303/BNT323 | EXPERIMENTAL | Enrolled patients will receive DB-1303/BNT323 by intravenous (I.V.) infusion |
| T-DM1 | EXPERIMENTAL | Enrolled patients will receive T-DM1 by I.V. infusion |
| Name | Type | Description |
|---|---|---|
| DB-1303/BNT323 | DRUG | Administered I.V. |
| T-DM1 | DRUG | Administered I.V. |
Inclusion Criteria: * Male or female adults ≥ 18 years at the time of voluntary signing of informed consent. * Pathologically confirmed unresectable or metastatic HER2 positive breast cancer previously treated with trastuzumab and taxane * Eastern Cooperative Oncology Group (ECOG) performance statu...