CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Gemcitabine +2 moredrug
Likely dose
Gemcitabine 1000 mg/m² IV on Days 1 and 8; Trastuzumab 2 mg/kg IV weekly (4 mg/kg loading dose if not dosed within prior 3 weeks); Cisplatin 30 mg/m² IV on Days 1 and 8AI-extracted
Key inclusion· 5
  • ✓Invasive metastatic breast cancer with HER2/neu 3+ by IHC (confirmed by Ohio State University pathology) or positive FISH
  • ✓Histologically confirmed invasive breast cancer from original diagnosis and/or metastatic disease diagnosis
  • ✓Detectable disease clinically or radiographically (positive bone scan allowed as sole site; bone marrow-only disease excluded)
  • ✓Normal left ventricular function with LVEF >50% by echocardiogram or MUGA within preceding 4 weeks
Key exclusion· 5
  • ✕Evidence of congestive heart failure, symptoms of coronary artery disease, serious cardiac arrhythmias, or prior myocardial infarction on EKG or ECHO
  • ✕CNS (central nervous system) metastatic disease
  • ✕Active infection at time of registration
  • ✕Pregnant or nursing women

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00201760
NCT00201760Phase 2Completed
CompareCT.gov

A Randomized Phase II Study of Gemcitabine/ Trastuzumab and Gemcitabine/ Cisplatin/ Trastuzumab in Patients With Metastatic Breast Cancer

Kari Kendra·interventional·Posted Sep 20, 2005·Updated Dec 27, 2017

In Brief

A Phase 2 clinical trial evaluating Gemcitabine, Trastuzumab, and 1 other intervention for Breast Cancer. Completed, enrolled 10 participants across 1 site.

Detailed Summary

This study determines the proportion of metastatic breast cancer patients progression free after 6 months when treated with gemcitabine/ cisplatin/ trastuzumab or gemcitabine/ trastuzumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsEli Lilly and Company

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartFeb 25, 2005
Primary CompletionOct 31, 2009
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 20.8 years ago

Interventions

Gemcitabinedrug

1000 mg/m2 IV over 30 minutes on Days 1 and 8.

Trastuzumabdrug

2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.

Cisplatindrug

30 mg/m2 IV on Day 1 and Day 8.