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Eligibility
for females ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

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 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 pCR.

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

  • Ronald Yanagihara, M.D.
    Gilroy, California, 95020, USA
  • California Cancer Care
    Greenbrae, California, 94904, USA
  • San Francisco Oncology Associates
    San Francisco, California, 94115, USA
  • Redwood Regional Medical Group
    Santa Rosa, California, 95403, USA
  • The Cancer Prevention and Treatment Center
    Soquel, California, 95073, USA
  • Cedars-Sinai Medical Group
    Beverly Hills, California, 90211, USA
  • Glendale Adventist Medical Center Cancer Services
    Glendale, California, 91206, USA
  • Beaver Medical Group, L.P.
    Highland, California, 92346, USA
  • Breastlink Medical Group
    Long Beach, California, 90806, USA
  • Long Beach Memorial Medical Center
    Long Beach, California, 90806, USA
  • Facey Medical Group
    Mission Hills, California, 91345, USA
  • Gynecologic Oncology Associates
    Newport Beach, California, 92663, USA
  • Ventura County Hematology-Oncology Specialists
    Oxnard, California, 93030, USA
  • Desert Hematology Oncology Medical Group, Inc
    Rancho Mirage, California, 92270, USA

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Puma Biotechnology, Inc.
ID
NCT00878709
Phase
Phase 3
Study Type
Interventional
Last Updated
March 2017