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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03975647 | A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 466 | — | — | Oct 2, 2019 | Mar 10, 2029 | Mar 30, 2026 | 486 | United States, Australia +18 |
PFS as per investigator was defined as the time from the date of randomization to the investigator assessment of disease progression (PD) as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimiter (mm). Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment.
| Arm | Type | Description |
|---|---|---|
| Tucatinib + T-DM1 | EXPERIMENTAL | Tucatinib + T-DM1 |
| Placebo + T-DM1 | ACTIVE_COMPARATOR | Placebo + T-DM1 |
| Name | Type | Description |
|---|---|---|
| tucatinib | DRUG | 300mg given twice per day by mouth (orally) |
| placebo | DRUG | Given twice per day orally |
| T-DM1 | DRUG | 3.6 mg/kg given into the vein (IV; intravenously) every 21 days |
* Inclusion Criteria: * Histologically confirmed HER2+ breast carcinoma as determined by a sponsor-designated central laboratory * History of prior treatment with a taxane and trastuzumab in any setting, separately or in combination * Have progression of unresectable locally advanced/metastat...