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



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
  • Ronald Yanagihara, M.D.
    Gilroy, California, 95020, United States
  • Ventura County Hematology-Oncology Specialists
    Oxnard, California, 93030, United States
  • Facey Medical Group
    Mission Hills, California, 91345, United States
  • Glendale Adventist Medical Center Cancer Services
    Glendale, California, 91206, United States
  • Cedars-Sinai Medical Group
    Beverly Hills, California, 90211, United States
  • Breastlink Medical Group
    Long Beach, California, 90806, United States
  • Long Beach Memorial Medical Center
    Long Beach, California, 90806, United States
  • Beaver Medical Group, L.P.
    Highland, California, 92346, United States
  • Gynecologic Oncology Associates
    Newport Beach, California, 92663, United States
  • Desert Hematology Oncology Medical Group, Inc
    Rancho Mirage, California, 92270, 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
May 16, 2018