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Table 1 Completed clinical trials of anti-HER2 monoclonal antibodies

From: Development and clinical application of anti-HER2 monoclonal and bispecific antibodies for cancer treatment

Drug Identifier Disease Phase Status Treatment arms Endpoints
Trastuzumab NCT01450696 (HELOISE) HER2+ gastric cancer 3 Completed a. Capecitabine + cisplatin + trastuzumab (6 mg/kg)
b. Capecitabine + cisplatin + trastuzumab (10 mg/kg)
OS
a. 12.5 months
b. 10.6 months
Ctrough increased in high dose trastuzumab
Trastuzumab NCT01041404 (ToGA) HER2+ advanced gastric cancer 3 Completed a. Trastuzumab + fluoropyrimidine + cisplatin
b. Fluoropyrimidine + cisplatin
OS
a. 13.8 months
b. 11.1 months
Pertuzumab NCT00545688 (NeoSphere) HER2+ breast cancer 2 Completed a. Trastuzumab + docetaxel
b. Trastuzumab + docetaxel + pertuzumab
c. Trastuzumab + pertuzumab
d. Pertuzumab + docetaxel
pCR
a. 29.0%
b. 45.8%
c. 16.8%
d. 24.0%
PFS
a. 81%
b. 86%
c. 73%
d. 73%
DFS
a. 81%
b. 84%
c. 80%
d. 75%
Pertuzumab NCT00567190 (CLEOPATRA) HER2+ metastatic breast cancer 3 Completed a. Pertuzumab + trastuzumab + docetaxel
b. Placebo + trastuzumab + docetaxel
OS
a. 56.5 months
b. 40.8 months
PFS
a. 18.7 months
b. 12.4 months
Pertuzumab NCT00976989 (TRYPHAENA) HER2+ breast cancer 2 Completed a. Pertuzumab + trastuzumab + FEC
b. Pertuzumab + trastuzumab + docetaxel + FEC
c. Pertuzumab + trastuzumab + docetaxel + carboplatin
pCR
a. 61.6%
b. 57.3%
c. 66.2%
CCR
a. 50.7%
b. 28.0%
c. 40.3%
Pertuzumab
T-DM1
NCT00951665 HER2+ locally advanced/metastatic breast cancer 1/2 Completed a. T-DM1 3.6 mg/kg (Q3W) + paclitaxel 80 mg/m2 (QW)
b. T-DM1 3.6 mg/kg (Q3W) + paclitaxel 80 mg/m2 (QW) + pertuzumab (Q3W)
Total ORR: 50.0%
Total CBR: 56.8%
Total incidence of grade 3 or worse AEs: 77.3%
Pertuzumab
T-DM1
NCT00951665 HER2+ locally advanced/metastatic breast cancer 1/2 Completed a. T-DM1 3.6 mg/kg (Q3W) + paclitaxel 80 mg/m2 (QW)
b. T-DM1 3.6 mg/kg (Q3W) + paclitaxel 80 mg/m2 (QW) + pertuzumab (Q3W)
Total ORR: 50.0%
Total CBR: 56.8%
Total incidence of grade 3 or worse AEs: 77.3%
T-DM1 NCT01641939 (GATSBY) HER2+ advanced gastric cancer 2/3 Completed a. T-DM1 (2.4 mg/kg)
b. Standard taxane therapy
Median follow-up
a. 17.5 months
b. 15.4 months
OS
a. 7.9 months
b. 8.6 months
Incidences of grade 3 or more AEs
a. 60%
b. 70%
T-DM1 NCT01120184 (MARIANNE) HER2+ locally advanced/metastatic breast cancer 3 Completed a. Trastuzumab + taxane
b. T-DM1 + pertuzumab
c. T-DM1 + placebo
Response rate
a. 67.9%
b. 59.7%
c. 64.2%
PFS
a. 13.7 months
b. 14.1 months
c. 15.2 months
Incidence of grade 3 or worse AEs
a. 54.1%
b. 45.4%
c. 46.2%
T-DM1 NCT00829166 (EMILIA) HER2+ locally advanced/metastatic breast cancer 3 Completed a. T-DM1
b. Capecitabine + lapatinib
ORR
a. 43.6%
b. 30.8%
PFS
a. 9.6 months
b. 6.4 months
OS
a. 30.9 months
b. 25.1 months
Incidence of grade 3 or worse AEs
a. 57%
b. 41%
T-DM1 NCT01419197 (TH3RESA) HER2+ breast cancer 3 Completed a. T-DM1
b. Treatment of physician’s choice
OS
a. 22.7 months
b. 15.8 months
PFS
a. 6.2 months
b. 3.3 months
Incidence of grade 3 or worse AEs
a. 40%
b. 47%
MM-302 NCT02213744 (HERMIONE) HER2+ locally advanced/metastatic breast cancer 2/3 Completed a. MM-302 + trastuzumab
b. Chemotherapy of physician’s choice + trastuzumab
OS
a. 13.8 months
b. 11.1 months
  1. The details of Table 1 derived from http://clinicaltrials.gov/
  2. FEC, 5-fluorouracil, epirubicin, cyclophosphamide, CCR clinical complete response, Q3W every three weeks, QW every week, CBR clinical benefit, rateC trough trastuzumab serum trough concentration, ORR objective response rate