for females ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Amy Chien



The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.

Official Title

A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer


Breast Cancer HER-2/erbB-2 positive breast cancer adjuvant therapy neratinib HKI-272 Nerlynx PB-272 Breast Neoplasms Trastuzumab


You can join if…

Open to females ages 18 years and up

  • Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.
  • Been treated for early breast cancer with standard of care duration of trastuzumab.
  • Could have been treated neoadjuvantly but have not reached pathologic complete response.

You CAN'T join if...

  • Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.
  • History of heart disease.
  • QTc interval >0.45 seconds
  • History of gastrointestinal disease with diarrhea as the major symptom.


  • Helen Diller Family University of California San Francisco Comprehensive Cancer Center
    San Francisco California 94115 United States
  • San Francisco Oncology Associates
    San Francisco California 94115 United States
  • California Cancer Care
    Greenbrae California 94904 United States
  • Redwood Regional Medical Group
    Santa Rosa California 95403 United States
  • The Cancer Prevention and Treatment Center
    Soquel California 95073 United States


in progress, not accepting new patients
Start Date
Completion Date
Puma Biotechnology, Inc.
Phase 3
Lead Scientist
Amy Chien
Study Type
Last Updated
August 3, 2018