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
Not Applicable
Recruiting
- Registration Number
- PER-008-10
- Lead Sponsor
- PUMA BIOTECHNOLOGY INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 3
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method