NCT00777101

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

A Phase 2 Randomized Open-Label Study of Neratinib Versus Lapatinib Plus Capecitabine For The Treatment Of ErbB-2 Positive Locally Advanced Or Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: Puma Biotechnology, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Breast Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Neratinib	Tablets 240 mg orally once per day until disease progression or unacceptable toxicity
DRUG	Lapatinib	Tablets 1250 mg orally once per day until disease progression or unacceptable toxicity.
DRUG	Capecitabine	Tablets 2000 mg/m² given orally in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.

Timeline

• Start date: 2009-02-04
• Primary completion: 2011-03-01
• Completion: 2018-06-03
• First posted: 2008-10-22
• Last updated: 2018-08-09
• Results posted: 2017-11-09

Locations

152 sites across 31 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Jordan, Mexico, Poland, Puerto Rico, Romania, Russia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study