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

Puma Biotechnology

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Other: placebo; Drug: neratinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00878709

3144A2-3004 / B1891004

Details and patient eligibility

About

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.

Enrollment: 2,840 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,840 participants in 2 patient groups, including a placebo group

Neratinib

Experimental group

Description:

240 mg orally daily for one year

Treatment:

Drug: neratinib

Placebo

Placebo Comparator group

Description:

orally daily for one year

Treatment:

Other: placebo