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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04494425 | Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 866 | — | — | Jul 24, 2020 | Jun 19, 2026 | Mar 4, 2026 | 293 | United States, Argentina +26 |
PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by BICR was defined as the time from the date of randomization until the date of PD, as defined or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 millimeter (mm) from nadir. Median PFS was calculated using Kaplan-Meier method and its confidence interval (CI) using Brookmeyer-Crowley method.
| Arm | Type | Description |
|---|---|---|
| Trastuzumab deruxtecan | EXPERIMENTAL | Trastuzumab deruxtecan (T-DXd; DS-8201a) arm |
| Standard of Care | ACTIVE_COMPARATOR | Investigator's choice standard of care chemotherapy (capecitabine, paclitaxel, nab-paclitaxel) arm |
| Name | Type | Description |
|---|---|---|
| Trastuzumab deruxtecan | DRUG | Trastuzumab deruxtecan by intravenous infusion |
| Capecitabine | DRUG | Investigator's choice standard of care single agent chemotherapy; capecitabine tablets will be given orally. |
| Paclitaxel | DRUG | Investigator's choice standard of care single agent chemotherapy; paclitaxel by intravenous infusion. |
| Nab-Paclitaxel | DRUG | Investigator's choice standard of care single agent chemotherapy; nab-paclitaxel by intravenous infusion |
Key Inclusion Criteria: * Patients must be ≥18 years of age * Pathologically documented breast cancer that: 1. is advanced or metastatic 2. has a history of HER2-low or negative expression by local test, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested) 3. ...