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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04784715 | Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09) | PHASE3 | ACTIVE NOT_RECRUITING | 1,157 | — | — | Apr 26, 2021 | Dec 30, 2029 | May 22, 2026 | 283 | United States, Argentina +25 |
Defined as time from date of randomisation until the date of objective radiological disease progression according to Blinded Independent Central Review (BICR) using RECIST 1.1 or death by any cause.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Trastuzumab deruxtecan (T-DXd) plus pertuzumab-matching placebo |
| Arm B | EXPERIMENTAL | Trastuzumab deruxtecan (T-DXd) plus pertuzumab |
| Arm C | ACTIVE_COMPARATOR | Standard of care (Taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab) |
| Name | Type | Description |
|---|---|---|
| Trastuzumab deruxtecan | DRUG | Administered by intravenous infusion |
| Placebo | DRUG | Administered by intravenous infusion |
| Taxane | DRUG | Investigator's choice of docetaxel or paclitaxel administered by intravenous infusion |
| Pertuzumab | DRUG | Administered by intravenous infusion |
| Trastuzumab | DRUG | Administered by intravenous infusion |
Key Inclusion Criteria: * Patients must be ≥18 years of age * Pathologically documented breast cancer that: 1. is advanced or metastatic 2. is locally assessed and prospectively centrally confirmed as HER2-positive (IHC3+ or ISH+) 3. is documented by local testing as hormone receptor (HR)-po...