Trials involving anti-HER2 treatment

Studya YearNo. of patientsDuration (years)Early vs metastaticAnthracyclineFollow-up (years)Echocardiography resultLVEF drop (%)Heart failure incidence (%)Cardiac death (%)
OHERA7 20193,7331EarlyYes54+23< 1
KATHERINE8 20191,4860.4EarlyNo54+NANA0
NSABP9 20174071EarlyYes54+1NA< 1
HERA10 20175,0991–2EarlyNo104+< 1NANA
APHINITY11 20174,8051EarlyNo105+NA< 1< 1
Dang et al12 20164061BothNo44+3< 1NA
HORG13 20154811EarlyNo73+< 100
CLEOPATRA14 20138041BothNo33+1< 1< 1
NeoSphere15 20124170.4BothNo2 weeks3+< 1< 10
BCIRG-00616 20113,2221BothYes57+14< 10
Slamon et al6,b 20012340.8MetastaticYes> 2NA16270
  • a All trials included radiation therapy and were adjudicated.

  • b Pivotal trial leading to stringent US Food and Drug Administration recommendations for cardiac surveillance.

  • APHINITY = A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer; BCIRG = Breast Cancer International Research Group; CLEOPATRA = A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer; HER2 = human epidermal growth factor receptor 2; HERA = HERceptin Adjuvant; HORG = Hellenic Oncology Research Group; KATHERINE = A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy; LVEF = left ventricular ejection fraction; NA = not available; NeoSphere = A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer; NSABP = National Surgical Adjuvant Breast and Bowel Project; OHERA = Observational Study of Cardiac Events in Patients with HER2-Positive EBC Treated with Herceptin