NCT00915018

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

A Randomized, Open-Label, Two-Arm Study Of Neratinib Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel As First-Line Treatment For ErbB-2-Positive Locally Recurrent Or Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 479 (actual)
• Sponsor: Puma Biotechnology, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Neratinib	Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
DRUG	Trastuzumab	Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
DRUG	Paclitaxel	Paclitaxel - 80 mg/m² IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Timeline

• Start date: 2009-08-21
• Primary completion: 2013-08-01
• Completion: 2018-06-28
• First posted: 2009-06-05
• Last updated: 2018-08-22
• Results posted: 2017-11-06

Locations

195 sites across 35 countries: United States, Australia, Belarus, Belgium, Bulgaria, Canada, China, Croatia, Denmark, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Malta, Poland, Portugal, Romania, Serbia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, The Bahamas, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study