Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

• Status: Completed
• Trial end date: 2019-10-04
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Puma Biotechnology, Inc.
• Treatments: Trastuzumab

Criteria

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 pathologic complete response.

Exclusion Criteria:

• Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.

• History of heart disease.

• Corrected QT (QTc) interval >0.45 seconds

• History of gastrointestinal disease with diarrhea as the major symptom.