At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 13 enrolled
Drug / intervention
Herceptin +5 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.
Phase I Trial of Afatinib in Combination With 3 Weekly Trastuzumab in Patients With Tumours Overexpressing HER2. Once the MTD of Afatinib With 3 Weekly Trastuzumab Was Established the Safety of This Dose Will be Assessed Also in Combination With Weekly Trastuzumab.
In Brief
A Phase 1 clinical trial evaluating Herceptin, afatinib, and 1 other intervention for Breast Neoplasms and Stomach Neoplasms. Completed, enrolled 13 participants across 3 sites.
Detailed Summary
The aim of the study is to determine the Maximum Tolerated Dose (MTD) of afatinib in combination with 3-weekly trastuzumab in HER2 overexpressing cancer and to assess the efficacy of afatinib given at the MTD dosage, with 3-weekly trastuzumab in HER2 overexpressing metastatic breast cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms, Stomach Neoplasms
CountriesFrance
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2012
First PostedJul 2012
Primary CompletionJun 2016
TodayJul 2026
First PostedJul 25, 2012
Enrollment StartJul 23, 2012
Primary CompletionJun 23, 2016
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 13.9 years ago
Interventions
Herceptindrug
3-weekly
afatinibdrug
at MTD level
trastuzumabdrug
3-weekly
Herceptindrug
weekly
afatinibdrug
at MTD level
afatinibdrug
escalating dose