CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
Trastuzumab and non-pegylated liposomal doxorubicindrug
Likely dose
Trastuzumab and non-pegylated liposomal doxorubicin 3.6 mg/kgfrom 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/NCT02562378
NCT02562378Phase 1Completed
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Phase I Multicenter Clinical Trial Evaluating the Combination of Trastuzumab Emtansine (T-DM1) and Non-pegylated Liposomal Doxorubicin in HER2-positive Metastatic Breast Cancer

MedSIR·interventional·Posted Sep 29, 2015·Updated Feb 23, 2022

In Brief

A Phase 1 clinical trial evaluating Trastuzumab and non-pegylated liposomal doxorubicin for Breast Cancer. Completed, enrolled 15 participants across 4 sites in 2 countries.

Detailed Summary

The primary goal is to determine the maximum tolerated dose (MTD) of the combination of T-DM1 and non-pegylated liposomal doxorubicin in metastatic breast cancer (mBC) patients previously treated with taxanes and trastuzumab-based therapy. In addition, pharmacokinetic data on the combination of T-DM1 and liposomal doxorubicin will be obtained.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesFrance, Spain
CollaboratorsRoche Pharma AG, Experior

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 29, 2015
Enrollment StartOct 1, 2015
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 10.8 years ago

Interventions

Trastuzumab and non-pegylated liposomal doxorubicindrug

3 Cohorts (3+3 design): Cohort 1- Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV Cohort 2- Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV Cohort 3- Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV