Trials involving anti-HER2 treatment
| Studya Year | No. of patients | Duration (years) | Early vs metastatic | Anthracycline | Follow-up (years) | Echocardiography result | LVEF drop (%) | Heart failure incidence (%) | Cardiac death (%) |
|---|---|---|---|---|---|---|---|---|---|
| OHERA7 2019 | 3,733 | 1 | Early | Yes | 5 | 4+ | 2 | 3 | < 1 |
| KATHERINE8 2019 | 1,486 | 0.4 | Early | No | 5 | 4+ | NA | NA | 0 |
| NSABP9 2017 | 407 | 1 | Early | Yes | 5 | 4+ | 1 | NA | < 1 |
| HERA10 2017 | 5,099 | 1–2 | Early | No | 10 | 4+ | < 1 | NA | NA |
| APHINITY11 2017 | 4,805 | 1 | Early | No | 10 | 5+ | NA | < 1 | < 1 |
| Dang et al12 2016 | 406 | 1 | Both | No | 4 | 4+ | 3 | < 1 | NA |
| HORG13 2015 | 481 | 1 | Early | No | 7 | 3+ | < 1 | 0 | 0 |
| CLEOPATRA14 2013 | 804 | 1 | Both | No | 3 | 3+ | 1 | < 1 | < 1 |
| NeoSphere15 2012 | 417 | 0.4 | Both | No | 2 weeks | 3+ | < 1 | < 1 | 0 |
| BCIRG-00616 2011 | 3,222 | 1 | Both | Yes | 5 | 7+ | 14 | < 1 | 0 |
| Slamon et al6,b 2001 | 234 | 0.8 | Metastatic | Yes | > 2 | NA | 16 | 27 | 0 |
↵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