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Neratinib Improves PFS in HER2+ Metastatic Breast Cancer

Gina Columbus @ginacolumbusonc
Published: Tuesday, Dec 18, 2018

Alan H. Auerbach

Alan H. Auerbach

Neratinib (Nerlynx) led to a statistically significant improvement in centrally confirmed progression-free survival (PFS) compared with lapatinib (Tykerb) and capecitabine in patients with HER2-positive metastatic breast cancer who have failed 2 or more prior lines of HER2-directed therapy, according to topline findings of the phase III NALA trial (NCT01808573).1

Results of the analysis demonstrated that, in both the EXTENT and CONTROL studies, FACT-B total score decreases were seen in early months followed by recovery towards baseline levels.


  1. Puma Biotechnology Announces Top Line Results of the Phase III NALA Trial of Neratinib in Patients with HER2-Positive Metastatic Breast Cancer. Puma BioTechnology. Published December 17, 2018." . Accessed December 17, 2018.
  2. Singh H, Walker AJ, Amiri-Kordestani L, et al. U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer. Clin Cancer Res. 2018;24(15):3486-3491. doi: 10.1158/1078-0432.CCR-17-3628.
  3. Delalogue S, Hurvitz S, Chan N, et al. The impact of neratinib with or without anti-diarrheal prophylaxis on health-related quality of life in HER2+ early-stage breast cancer: Analyses from the ExteNET and CONTROL trials. In: Proceedings from the 2018 San Antonio Breast Cancer Symposium; December 4-8, 2018; San Antonio, Texas. Abstract P2-13-03.

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