CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Herceptin +1 moredrug
Likely dose
Herceptin 4 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/NCT00429104
NCT00429104Phase 2Completed
CompareCT.gov

Phase II Study of GM-CSF to Overcome Herceptin-Resistant HER-2/Neu-Overexpressing Metastatic Breast Cancer

M.D. Anderson Cancer Center·interventional·Posted Jan 31, 2007·Updated Dec 6, 2012

In Brief

A Phase 2 clinical trial evaluating Herceptin and GM-CSF for Breast Cancer. Completed, enrolled 18 participants across 1 site.

Detailed Summary

Primary Objectives: 1. To determine the patient's tumor response rate that this protocol will produce. 2. To determine the 1 year progression-free survival that this protocol will produce. Secondary Objective: 1\. To determine whether antibody-dependent cell-mediated cytotoxicity (ADCC) is the mechanism of overcoming Herceptin-resistance by use of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF).

Study Details

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

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 31, 2007
Enrollment StartAug 1, 2002
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 19.4 years ago

Interventions

Herceptindrug

4 mg/kg IV Over 90 Minutes

GM-CSFdrug

250 mcg/m\^2 Subcutaneously