CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Trastuzumab +1 moredrug
Likely dose
Trastuzumab 8 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/NCT00297596
NCT00297596Phase 2Completed
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A Phase II Trial of Trastuzumab and Oxaliplatin in Patients With Metastatic Breast Cancer

SCRI Development Innovations, LLC·interventional·Posted Feb 28, 2006·Updated Oct 28, 2021

In Brief

A Phase 2 clinical trial evaluating Trastuzumab and Oxaliplatin for Breast Cancer. Completed, enrolled 25 participants across 7 sites.

Detailed Summary

This is a phase II study of the combination of oxaliplatin and trastuzumab as first or second line therapy in patients with stage IV, metastatic breast cancer

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsSanofi

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 28, 2006
Enrollment StartFeb 1, 2006
Primary CompletionOct 1, 2008
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 20.3 years ago

Interventions

Trastuzumabdrug

Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.

Oxaliplatindrug

Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab