Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments neratinib, placebo
Phase phase 3
Targets HER2, EGFR
Sponsor Puma Biotechnology, Inc.
Start date July 2009
End date November 2013
Trial size 2840 participants
Trial identifier NCT00878709, 3144A2-3004, B1891004

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
neratinib HKI-272
240 mg orally daily for 1 year
(Placebo Comparator)
placebo
orally daily for 1 year

Primary Outcomes

Measure
disease free survival (DFS)
time frame: Two years

Secondary Outcomes

Measure
Time to Distant Recurrence (TTDR)
time frame: Two through Five years
Disease free survival including ductal carcinoma in situ (DFS-DCIS)
time frame: Two through Five years
Distant disease free survival (DDFS)
time frame: Two through Five years
Incidence of central nervous system recurrence
time frame: Two through Five years
Overall survival
time frame: Ten years
Short and long term safety of neratinib
time frame: Thirteen months
disease free survival (DFS)
time frame: Five years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Puma Biotechnology, Inc..