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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05113251 | Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 927 | — | — | Oct 25, 2021 | Apr 30, 2027 | Feb 23, 2026 | 145 | United States, Brazil +16 |
Proportion of participants who have no evidence by H\&E staining of residual invasive disease
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Trastuzumab deruxtecan |
| Arm B | EXPERIMENTAL | T-DXd, followed by THP |
| Arm C | ACTIVE_COMPARATOR | doxorubicin and cyclophosphamide, followed by THP |
| Name | Type | Description |
|---|---|---|
| Trastuzumab Deruxtecan | DRUG | administered by intravenous infusion |
| Paclitaxel | DRUG | administered by intravenous infusion |
| Trastuzumab | DRUG | administered by intravenous infusion |
| Pertuzumab | DRUG | administered by intravenous infusion |
| Doxorubicin | DRUG | administered by intravenous infusion |
| cyclophosphamide | DRUG | administered by intravenous infusion |
Key Inclusion Criteria: * Patients must be at least 18 years of age. * Histologically documented HER2-positive early breast cancer (EBC) participants, including clinical stage at presentation (based on mammogram or breast MRI assessment): T0-4 (inclusive of inflammatory breast cancer), N1-3, M0 or ...