|Phase III||Treatment||Completed||18 and over||Pharmaceutical / Industry||3144A2-3004|
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.
- 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.
- 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.
Trial Lead Organizations/Sponsors
Puma Biotechnology, Incorporated
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00878709
ClinicalTrials.gov processed this data on December 04, 2013
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