CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 49 enrolled
Drug / intervention
Bevacizumab +2 moredrug
Likely dose
Bevacizumab 10 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/NCT01094184
NCT01094184Phase 4Completed
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Open-Label Study of Bevacizumab (Avastin®) and Taxane Monotherapy for the First-Line Treatment of Patients With Advanced Triple Negative Breast Cancer

Hoffmann-La Roche·interventional·Posted Mar 26, 2010·Updated Mar 22, 2018

In Brief

A Phase 4 clinical trial evaluating Bevacizumab, Paclitaxel, and 1 other intervention for Breast Cancer. Completed, enrolled 49 participants across 10 sites.

Detailed Summary

This open-label, multi-center study will evaluate the safety, tolerability and effect of bevacizumab (Avastin) in combination with taxane (paclitaxel/ docetaxel) monotherapy on disease progression, survival time and Karnofsky performance status in female participants with estrogen-, progesterone- and human epidermal growth factor receptor 2 (HER2)-negative (triple-negative) breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 26, 2010
Enrollment StartMar 1, 2010
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 16.3 years ago

Interventions

Bevacizumabdrug

Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.

Paclitaxeldrug

Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.

Docetaxeldrug

Docetaxel will be administered as intravenous infusion Q3W as per discretion of the treating physician. Protocol amendment 2 (dated 17-Feb-2011) removed the option to choose docetaxel.