Table 2. Ongoing phase III clinical trials of investigational agents in HER2-positive metastatic breast cancer.
| Trial | Setting | Treatment regimen | Target accrual | Statusa |
|---|---|---|---|---|
| Pertuzumab | ||||
| CLEOPATRA (NCT00567190) | First-line | Trastuzumab/docetaxel/pertuzumab vs trastuzumab/docetaxel/placebo | 808 | Active, no longer recruiting |
| T-DM1 | ||||
| MARIANNE (NCT01120184) | First-line | Trastuzumab+taxane (docetaxel or paclitaxel) vs T-DM1+pertuzumab vs T-DM1+placebo | 1,092 | Recruiting |
| EMILIA (NCT00829166) | Relapsed (after trastuzumab+taxane) | T-DM1 vs lapatinib+capecitabine | 980 | Recruiting |
| NCT01419197 | Relapsed (progression after ⩾2 prior HER2-targeted therapies) | T-DM1 vs treatment of physician's choice | 795 | Recruiting |
| Afatinib | ||||
| LUX-Breast 1 (NCT01125566) | Second-line (after trastuzumab progression) | Afatinib+vinorelbine vs trastuzumab+vinorelbine | 780 | Recruiting |
| Everolimus | ||||
| BOLERO-1 (NCT00876395) | First-line | Trastuzumab/paclitaxel/everolimus vs trastuzumab/paclitaxel/placebo | 717 | Recruiting |
| BOLERO-3 (NCT01007942) | Relapsed (after trastuzumab resistance+taxane) | Trastuzumab/vinorelbine/everolimus vs trastuzumab/vinorelbine/placebo | 572 | Recruiting |
Abbreviations: HER=human epidermal growth factor receptor; T-DM1=trastuzumab DM1.
a
ClinicalTrials.gov accessed October 14, 2011.