Drugs | Targets | Study | Identifier number | Phase | Setting | Primary endpoint | Therapy | Results | Â |
---|---|---|---|---|---|---|---|---|---|
Pertuzumab | HER2/3 | CLEOPATRA | NCT00567190 | Phase III | MBC/locally recurent/unresectable | PFS | Trastuzumab + docetaxel + pertuzumab | 18.7 months | HR 0.69; 95% CI 0.58-0.81; P <0.001 |
 |  |  |  |  | in first line |  | trastuzumab + docetaxel + placebo | 12.4 months |  |
 |  | NEOSPHERE | NCT00545688 | Phase II | Neo adjuvant | pCR | Trastuzumab + docetaxel | 29.0% |  |
 |  |  |  |  |  |  | Trastuzumab + pertuzumab + docetaxel | 45.8% | P = 0.0141 |
 |  |  |  |  |  |  | Pertuzumab + docetaxel | 24.0% |  |
 |  |  |  |  |  |  | Trastuzumab + pertuzumab | 16.8% |  |
T-DM1 | HER2 | EMILIA | NCT00829166 | Phase III | MBC | PFS | T-DM1 | 9.6 months | HR 0.65; 95% CI 0.55-0.77; P <0.001 |
Lapatinib + Capecitabine | 6.4 months |  | |||||||
 |  | TH3RESA | NCT01419197 | Phase III | MBC (in third line) |  | T-DM1 | 6.2 months | HR 0.528; 95% CI 0.422-0.661; P <0.0001 |
Physician’s choice treatment | 3.3 months |  | |||||||
Lapatinib | HER1/HER2 | EGF104900 | NCT00320385 | Phase III | MBC trastuzumab resistant | PFS | Lapatinib + trastuzumab Lapatinib | 11.1 months | HR 0.74; 95% CI 0.58-0.94; P = 0.011 |
8.1 months |  | ||||||||
 |  | NSABP B-41 | NCT00486668 | Phase III | Neo adjuvant | pCR | Paclitaxel + Trastuzumab | 53.5% |  |
 |  |  |  |  |  |  | Paclitaxel + Lapatinb | 52.5% |  |
 |  |  |  |  |  |  | Paclitaxel + Lapatinib + Trastuzumab | 62.0% |  |
 |  | NeoALTTO | NCT00553358 | Phase III | Neo adjuvant | pCR | Paclitaxel + Trastuzumab | 29.5% |  |
 |  |  |  |  |  |  | Paclitaxel + Lapatinb | 24.7% |  |
 |  |  |  |  |  |  | Paclitaxel + Lapatinib + Trastuzumab | 51.3% | difference 21.1%; 95% CI 9.1-34.2; P = 0.0001). |
 |  | ALLTO | NCT00490139 | Phase III | Adjuvant | DFS | Trastuzumab | 86.0% |  |
 |  |  |  |  |  |  | Trastuzumab + Lapatinib | 88.0% |  |
Sequential Trastuzumab/Lapatinib | |||||||||
 |  | Geyer and al. | NCT00078572 | Phase III | Locally advanced/MBC | TTP | Capecitabine + Lapatinib Capecitabine | 8.4 months | HR 0.57; 95% CI 0.44-0.77; P <0.001 |
4.4 month |  | ||||||||
 |  | GeparQuinto | NCT00567554 | Phase III | Neo adjuvant | pCR | Chemotherapy + Trastuzumab | 30.3% | OR 0 . 68; 95% CI 0.47-0.97; P = 0 . 04 |
 |  |  |  |  |  |  | Chemotherapy + Lapatinib | 22.7% |  |
Bevacizumab | VEGFA | AVEREL |  | Phase III | Locally recurrent/MBC | PFS | Docetaxel + Trastuzumab + Bevacizumab Docetaxel + Trastuzumab | 16.8 months |  |
13.9 months | |||||||||
 |  | BETH | NCT00625898 | Phase III | Adjuvant | DFS | Chemotherapy + Trastuzumab + Bevacizumab Chemotherapy + Trastuzumab |  | HR 1.00; 95% CI 0.79-1.26 |
Everolimus | m TOR | BOLERO-3 | NCT01007942 | Phase III | Locally advanced/MBC | PFS | Trastuzumab + Vinorelbine + Everolimus Trastuzumab + Vinorelbine | 30.4 weeks | HR 0.78; 95% CI 0.65-0.96; P = 0.0067 |
25.1 weeks |  |