CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
Gemcitabine +1 moredrug
Likely dose
Gemcitabine 1000 mg/m² IV on days 1 and 8 plus cisplatin 35 mg/m² IV on days 1 and 8 of a 21-day cycleAI-extracted
Key inclusion· 3
  • ✓Female aged 18 to 75 years
  • ✓Confirmed diagnosis of metastatic breast cancer
  • ✓Able to attend regular clinic visits during treatment and 24 months of follow-up
Key exclusion· 4
  • ✕Pregnant or breastfeeding
  • ✕Laboratory parameters outside study limits
  • ✕Serious concomitant or acute infectious disease
  • ✕Use of experimental medications within the last month

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

Search/NCT00191815
NCT00191815Phase 2Completed
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Phase II Study of Gemcitabine Plus Cisplatin as First-line Treatment of Metastatic Breast Cancer

Eli Lilly and Company·interventional·Posted Sep 19, 2005·Updated Nov 11, 2009

In Brief

A Phase 2 clinical trial evaluating Gemcitabine and cisplatin for Breast Cancer. Completed, enrolled 70 participants across 2 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine the objective tumor response of the first-line therapy combination of gemcitabine and cisplatin in patients with metastatic breast cancer

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesGermany, Russia
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartOct 1, 2002
Study CompletionOct 1, 2007
TodayJul 2, 2026
Posted 20.8 years ago

Interventions

Gemcitabinedrug

Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).

cisplatindrug

Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).