Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

• Status: Completed
• Trial end date: 2018-06-03
• Target enrollment: 0
• Participant gender: Female

Summary

This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.

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

Details

• Lead Sponsor: Puma Biotechnology, Inc.
• Treatments: Capecitabine; Lapatinib

Criteria

Inclusion Criteria:

• Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer

• Prior use of Herceptin (trastuzumab), and a taxane

• Adequate cardiac and renal function

Exclusion Criteria:

• More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) [Tyverb]

• Bone as the only site of disease

• Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)

• Significant gastrointestinal disorder with diarrhea as major symptom