Overview

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.