• 1 Department of Breast Oncology, Aichi Cancer Center, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan
  • 2 Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka, 540-0006, Japan
  • 3 Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, KS013, Korea
  • 4 Division of Breast Oncology, Saitama Cancer Center, Saitama, 362-0806, Japan
  • 5 Hakuaikai Medical Corporation Sagara Hospital, Kagoshima City, 892-0845, Japan
  • 6 Department of Breast Oncology, Jichi Medical University Hospital, Tochigi, 329-0498, Japan
  • 7 Department of Medicine, Queen Mary Hospital, Hong Kong Island, Hong Kong
  • 8 Department of Breast Surgery, Hiroshima City Hospital, Hiroshima, 730-8518, Japan
  • 9 Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Hokkaido, 063-0005, Japan
  • 10 Division of Breast Surgery, Chiba Cancer Center, Chiba, 260-8717, Japan
  • 11 National Taiwan University Hospital, Taipei City, Taiwan
  • 12 Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China
  • 13 Division of Medical Oncology, National Cancer Centre Singapore, 169610, Singapore
  • 14 Clinical Oncology Unit, University Malaya Medical Centre, Kuala Lumpur, 50603, Malaysia
  • 15 Puma Biotechnology, Inc., Los Angeles, CA 90024, USA
  • 16 Breast Cancer Research Centre-WA & Curtin University, Perth, Australia
Future Oncol, 2019 Jul;15(21):2489-2501.
PMID: 31140297 DOI: 10.2217/fon-2019-0143


Aim: To evaluate the efficacy and safety of neratinib as extended adjuvant therapy in patients from Asia based on exploratory analyses of the Phase III ExteNET trial. Patients & methods: A total of 2840 women with early stage HER2-positive breast cancer were randomly assigned to neratinib 240 mg/day or placebo for 1 year after trastuzumab-based adjuvant therapy. Results: A total of 341 patients were from Asia (neratinib, n = 165; placebo, n = 176). 2-year invasive disease-free survival rates were 92.8 and 90.8% with neratinib and placebo, respectively (HR: 0.70; 95% CI: 0.31-1.55), and 5-year rates were 91.9 and 87.2%, respectively (HR: 0.57; 95% CI: 0.27-1.13). Diarrhea was the most common adverse event with neratinib. Conclusion: Extended adjuvant therapy with neratinib reduces disease recurrences in Asian women with HER2-positive breast cancer. Trial registration: NCT00878709.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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