CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 74 enrolled
Drug / intervention
Vinorelbine 25 mg/m2 weekly +2 moredrug
Likely dose
Vinorelbine 25 mg/m2 weeklyfrom 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/NCT01271725
NCT01271725Phase 2Completed
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LUX-Breast 2; An Open Label, Phase II Trial of Afatinib (BIBW 2992) in Patients With Metastatic HER2-overexpressing Breast Cancer Failing HER2-targeted Treatment in the Neoadjuvant and/or Adjuvant Treatment Setting

Boehringer Ingelheim·interventional·Posted Jan 7, 2011·Updated Jun 17, 2019

In Brief

A Phase 2 clinical trial evaluating Vinorelbine 25 mg/m2 weekly, Afatinib 40mg once daily (OD), and 1 other intervention for Breast Neoplasms. Completed, enrolled 74 participants across 27 sites in 6 countries.

Detailed Summary

The general aim of this study is to investigate the efficacy and safety of afatinib (BIBW 2992) alone and in combination with weekly paclitaxel or weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the neoadjuvant or adjuvant setting

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesHong Kong, India, Poland, Russia, Taiwan, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 7, 2011
Enrollment StartMay 24, 2011
Primary CompletionMar 13, 2017
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 15.5 years ago

Interventions

Vinorelbine 25 mg/m2 weeklydrug

Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy

Afatinib 40mg once daily (OD)drug

Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease

Paclitaxel 80 mg/m2 weeklydrug

Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy