Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer

• Status: Completed
• Trial end date: 2018-06-28
• Target enrollment: 0
• Participant gender: Female

Summary

This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Puma Biotechnology, Inc.
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel; Trastuzumab

Criteria

Inclusion Criteria:

• ErbB-2 positive locally recurrent or metastatic breast cancer

• Eastern Cooperative Oncology Group (ECOG) 0-2

• Measurable disease

• Availability of tumor tissue for HER2 status confirmation

Exclusion Criteria:

• Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent or metastatic disease

• Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting

• Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant therapy

• History of heart disease

• History of gastrointestinal disease