CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Afatinib once daily (OD) +1 moredrug
Likely dose
Not stated in 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/NCT01325428
NCT01325428Phase 2Completed
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An Open Label, Phase II Trial of Afatinib With or Without Vinorelbine for the Treatment of HER2-overexpressing Inflammatory Breast Cancer

Boehringer Ingelheim·interventional·Posted Mar 29, 2011·Updated Jul 19, 2016

In Brief

A Phase 2 clinical trial evaluating Afatinib once daily (OD) and Vinorelbine Weekly for Breast Neoplasms. Completed, enrolled 26 participants across 16 sites in 7 countries.

Detailed Summary

The general aim of this study is to investigate the efficacy and safety of afatinib alone and in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, locally advanced or metastatic inflammatory breast cancer. The study will include patients who have and have not failed prior trastuzumab treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesAustralia, Hong Kong, South Korea, Thailand, Tunisia, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 29, 2011
Enrollment StartAug 1, 2011
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.3 years ago

Interventions

Afatinib once daily (OD)drug

Patient to receive afatinib monotherapy until progression of their disease

Vinorelbine Weeklydrug

Patients additionally receive vinorelbine weekly on disease progression on afatinib monotherapy