CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Bevacizumab +2 moredrug
Likely dose
Bevacizumab 15 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/NCT01201265
NCT01201265Phase 2Completed

A Multi Centre, Pilot Phase II Trial Assessing the Efficacy and Safety of Bevacizumab + Gemcitabine + Carboplatin as First Line Treatment for Patients Diagnosed With Triple Negative Metastatic Breast Cancer

Hoffmann-La Roche·interventional·Posted Sep 14, 2010·Updated May 27, 2016

In Brief

A Phase 2 clinical trial evaluating Bevacizumab, Carboplatin, and 1 other intervention for Breast Cancer. Completed, enrolled 40 participants across 12 sites.

Detailed Summary

This multicenter study will assess the efficacy and safety of bevacizumab in combination with gemcitabine and cisplatin as first line treatment in participants with triple negative metastatic breast cancer. Participants will receive bevacizumab at a dose of 15 mg/kg intravenously (iv) every 3 weeks, plus gemcitabine (1000 mg/m2 iv) and carboplatin (iv to an area under curve \[AUC\]=2) on Days 1 and 8 of each 3-week cycle. Anticipated time on study treatment is until disease progression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesIndia
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 14, 2010
Enrollment StartFeb 1, 2011
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 15.8 years ago

Interventions

Bevacizumabdrug

15 mg/kg iv every 3 weeks

Carboplatindrug

to an AUC = 2, on days 1 and 8 of each 3-week cycle

Gemcitabinedrug

1000 mg/m2 iv on days 1 and 8 of each 3-week cycle