CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
gemcitabine +1 moredrug
Likely dose
Gemcitabine 1000 mg/m2 or 1250 mg/m2 intravenously on days 1 and 8 every 21 daysAI-extracted
Key inclusion· 5
  • ✓Histologically and/or cytologically confirmed breast cancer
  • ✓Prior chemotherapy for metastatic breast cancer with anthracycline and taxane regimen
  • ✓At least one measurable lesion
  • ✓ECOG performance status 0-1
Key exclusion· 4
  • ✕Interstitial pneumonia or pulmonary fibrosis
  • ✕Inflammatory carcinoma
  • ✕Symptomatic brain metastases
  • ✕Severe complications including cardiac infarction, infection, drug hypersensitivity, or uncontrolled diabetes

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

Search/NCT00191269
NCT00191269Phase 2Completed
CompareCT.gov

A Multicenter Study of LY188011 in Anthracyclines and Taxanes Pre-treated Metastatic/Recurrent Breast Cancer

Eli Lilly and Company·interventional·Posted Sep 19, 2005·Updated Mar 17, 2010

In Brief

A Phase 2 clinical trial evaluating gemcitabine for Metastatic Breast Cancer. Completed, enrolled 68 participants across 13 sites.

Detailed Summary

To investigate efficacy, safety and PK of GEM monotherapy after prior chemotherapy with anthracycline and taxane regimen for patients with metastatic breast cancer

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartJun 1, 2005
Primary CompletionMar 1, 2008
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.8 years ago

Interventions

gemcitabinedrug

1000 mg/m2, intravenous (IV), day 1 and day 8 every 21 days

gemcitabinedrug

1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days