CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 233 enrolled
Drug / intervention
Neratinib +2 moredrug
Likely dose
Neratinib 240 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00777101
NCT00777101Phase 2Completed
CompareCT.gov

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

Puma Biotechnology, Inc.·interventional·Posted Oct 22, 2008·Updated Aug 9, 2018

In Brief

A Phase 2 clinical trial evaluating Neratinib, Lapatinib, and 1 other intervention for Advanced Breast Cancer and Breast Cancer. Completed, enrolled 233 participants across 152 sites in 31 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Breast Cancer, Breast Cancer
CountriesAustralia, 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, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 22, 2008
Enrollment StartFeb 4, 2009
Primary CompletionMar 1, 2011
Study CompletionJun 3, 2018
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 17.7 years ago

Interventions

Neratinibdrug

Tablets 240 mg orally once per day until disease progression or unacceptable toxicity

Lapatinibdrug

Tablets 1250 mg orally once per day until disease progression or unacceptable toxicity.

Capecitabinedrug

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.