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Table 4 Landmark clinical trials in the development of HER2 inhibitors

From: Clinical development of targeted and immune based anti-cancer therapies

Drug Name Clinical Trial ID Trial Name Population Comparator Year Sponsor Phase N Median OS (months) Median PFS (months)
HER2 inhibitors
 Trastuzumab (Herceptin®)
  Trastuzumab (4 mg/kg followed by 2 mg/kg) + doxorubicin + cyclophosphamide NCT00004067   Breast cancer (HER2+) Doxorubicin + cyclophosphamide + paclitaxel 2000–2020 NSABP Foundation Inc 3 42,130 NA NA
  Trastuzumab (8 mg/kg followed by 6 mg/kg) + chemotherapy NCT01998906   Breast cancer (HER2+) Chemotherapy 2002–2012 Hoffmann-La Roche 3 330 NA NA
  Trastuzumab (4 mg/kg followed by 2 mg/kg) + docetaxel Marty et al. (2005) M77001 Breast cancer (HER2+) Docetaxel 2000–2005 Hoffmann-La Roche 2 186 31.2 vs 22.7 11.7 vs 6.1
  Trastuzumab (4 mg/kg followed by 2 mg/kg) + lapatinib NCT00320385   Breast cancer (HER2+) Lapatinib 2005–2010 GlaxoSmithKline 3 296 51.6 vs 39 (weeks) 12 vs 8.1 (weeks)
  Trastuzumab (8 mg/kg followed by 6 mg/kg) + fluorouracil + cisplatin + capecitabine NCT01041404 ToGA Study HER2+ advanced gastric cancer Fluorouracil + Cisplatin + Capecitabine 2005–2010 Hoffmann-La Roche 3 584 11.1 vs 13.8 5.5 vs 6.7
  Trastuzumab (4 mg/kg followed by 2 mg/kg) + chemotherapy NCT00021255   Breast cancer (HER2+) Chemotherapy 2001–2014 Sanofi 3 3222 78.9 vs 86 NA
  Trastuzumab (2 mg/kg i.v. weekly, or 6 mg/kg i.v. every 3 weeks) + chemotherapy NCT00448279 THOR Breast cancer (HER2+) Chemotherapy 2007–2010 Hoffmann-La Roche 3 58 19.1 vs 26.7 9.7 vs 9.4
 T-DM1 (Trastuzumab Emtansine/ Kadcyla®)
  T-DM1 (3.6 mg/kg/3w) NCT00829166 EMILIA Breast cancer (HER2+) Lapatinib + Capecitabine 2009–2015 Hoffmann-La Roche III 991 30.9 vs 25.1 9.6 vs 6.4
  T-DM1 (3.6 mg/kg/3w) NCT01419197 TH3RESA Breast cancer (HER2+) Physician’s choice 2011–2015 Hoffmann-La Roche III 602 22.7 vs 15.8 6.2 vs 3.3
 Pertuzumab (Perjeta®)
  Pertuzumab (420 mg/3w) + trastuzumab + docetaxel NCT00567190 CLEOPATRA Breast cancer (HER2+) Trastuzumab and Docetaxel 2008–2018 Hoffmann-La Roche III 808 56.5 vs 40.8 18.7 vs 12.4
  Pertuzumab (420 mg/3w) + trastuzumab + capecitabine NCT01026142 PHEREXA Breast cancer (HER2+) Trastuzumab + capecitabine 2010–2017 Hoffmann-La Roche III 452 37.2 vs 28.1 11.1 vs 9.0
  Pertuzumab (420 mg/3w) + trastuzumab + chemotherapy NCT01358877 APHINITY Breast cancer (HER2+) Trastuzumab + chemotherapy 2011–2016 Hoffmann-La Roche III 4804 NR 8.7 vs 7.1%
  Pertuzumab + T-DM1 NCT01120184 MARIANNE Breast cancer (HER2+) T-DM1 + Placebo 2010–2016 Hoffmann-La Roche III 1095 51.8 vs 53.7 15.2 vs 14.1
 Lapatinib (Tykerb®)
  Lapatinib (1250 mg/d) + capecitabine NCT00078572   Metastatic breast cancer (HER2+) Capecitabine 2004–2010 GSK III 408 10.4 vs 8.0 8.4 vs 4.4
  Lapatinib (1500 mg/d) NCT00073528   Metastatic breast cancer Letrozole 2003–2018 Novartis III 1285 33.3 vs 32.3 8.1 vs 3.0
  Lapatinib (1500 mg/d) NCT00374322 TEACH Early stage breast cancer Placebo 2006–2013 GSK III 3166 NR NR