Table 3.
Combinations of two or more mAbs and TKIs in Phase III trials
| Study | Number of patients | Arms | Endpoints | HR; 95% CI |
|---|---|---|---|---|
| CLEOPATRA50 (combination of mAbs) | 808 | Placebo + trastuzumab + docetaxel (control group) vs pertuzumab + trastuzumab + docetaxel (pertuzumab group) | PFS: 12.4 vs 18.5 months | HR 0.62; 95% CI 0.51–0.75; P<0.001 |
| Blackwell et al52 (combination of mAbs and TKIs) | 296* | Lapatinib vs lapatinib + trastuzumab | PFS | HR 0.73; 95% CI 0.57–0.93; P=0.008 |
| Baselga et al53 (combination of mAbs and TKIs in neoadjuvant setting) | 455** | Lapatinib vs trastuzumab vs lapatinib + trastuzumab | pCR was significantly higher in the combination group given lapatinib and trastuzumab than in monotherapy groups | 51.3%; 95% CI 43.1–59.5 |
Notes:
*
Patients with HER2-positive metastatic breast cancer who presented progression on previous trastuzumab regimens;
**
patients with HER2-positive early breast cancer with tumours >2 cm in diameter.
Abbreviations: CI, confidence interval; HR, hazard ratio; mAbs monoclonal antibodies; pCR, pathological complete response; PFS, progression-free survival; TKI, tyrosine kinase inhibitor; vs, versus.