Breast Cancer Clinical Trial

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

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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.

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Eligibility 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.

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

2840

Study ID:

NCT00878709

Recruitment Status:

Completed

Sponsor:

Puma Biotechnology, Inc.

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How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

2840

Study ID:

NCT00878709

Recruitment Status:

Completed

Sponsor:


Puma Biotechnology, Inc.

How clear is this clinincal trial information?

Clinical Trial Resources

SurvivorNet’s Guide To Clinical Trials: What Are They And Are They Right for You?
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