Summary

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

Description

Summary

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

Keywords

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

Eligibility

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.

Locations

  • 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

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Puma Biotechnology, Inc.
ID
NCT00878709
Phase
Phase 3
Lead Scientist
Amy Chien
Study Type
Interventional
Last Updated
August 3, 2018