CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
Gemcitabine +1 moredrug
Likely dose
Gemcitabine 2500 mgfrom 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/NCT00623233
NCT00623233Phase 2Completed

A Phase 2 Study of Gemcitabine and Bevacizumab as First-Line Treatment in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer Previously Treated With Taxanes

Eli Lilly and Company·interventional·Posted Feb 25, 2008·Updated Jan 9, 2012

In Brief

A Phase 2 clinical trial evaluating Gemcitabine and Bevacizumab for Metastatic Breast Cancer and Locally Advanced Breast Cancer. Completed, enrolled 52 participants across 16 sites.

Detailed Summary

To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in patients with advanced breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 25, 2008
Enrollment StartMar 1, 2008
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.4 years ago

Interventions

Gemcitabinedrug

Gemcitabine 2500 mg/m\^2 IV over 30 minutes given on Day 1 q 14 days prior to bevacizumab until PD or unacceptable toxicity.

Bevacizumabdrug

Bevacizumab 10 mg/kg IV over 90 minutes at Cycle 1; infusion time may have been decreased for subsequent cycles. (For example, if the first infusion was tolerated without an infusion-associated adverse event \[AE\], the second infusion was delivered over 60 minutes. If the 60-minute infusion was well tolerated, all subsequent infusions were delivered over 30 minutes.) Bevacizumab 10 mg/kg initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.