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Table 1 Summary of randomized trials testing new drugs in Her2-overexpressing breast cancers

From: Strategies to overcome trastuzumab resistance in HER2-overexpressing breast cancers: focus on new data from clinical trials

Drugs Targets Study Identifier number Phase Setting Primary endpoint Therapy Results  
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  
  1. CI, confidence interval; DFS, disease free survival; HR, hazard ratio; MBC, metastatic breast cancer; mTOR, mammalian target of rapamycin; OR, odds ratio; pCR, pathological complete response; PFS, progression free survival; TTP, time to progression; VEGFA, vascular endothelial growth factor A.