Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
Basic Trial Information
|Phase III||Treatment||Closed||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 Contact Information
Trial Lead Organizations/Sponsors
Puma Biotechnology, Incorporated
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00878709
ClinicalTrials.gov processed this data on May 20, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.