CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
bevacizumab [Avastin] +2 moredrug
Likely dose
bevacizumab [Avastin] 15mg/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/NCT00559754
NCT00559754Phase 2Completed

An Open Label Study to Assess the Effect of a Combination of Avastin and Docetaxel and Sequential Chemotherapy on Pathological Response in Patients With Primary Operable HER2 Negative Breast Cancer

Hoffmann-La Roche·interventional·Posted Nov 16, 2007·Updated Nov 10, 2014

In Brief

A Phase 2 clinical trial evaluating bevacizumab [Avastin], Docetaxel, and 1 other intervention for Breast Cancer. Completed, enrolled 72 participants across 6 sites.

Detailed Summary

This single arm study will assess the efficacy and safety of a combination of Avastin and docetaxel following cyclophosphamide and doxorubicin, in patients with HER2 negative operable breast cancer. Patients will receive 4 x 3 week cycles of chemotherapy with doxorubicin (60mg/m2 iv on day 1 of each cycle) and cyclophosphamide (600mg/m2 iv on day 1 of each cycle). They will then receive 4 x 3 week cycles of docetaxel (75mg/m2 on day 1 of each cycle) in combination with Avastin (15mg/kg on day 1 of each cycle). The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Study Details

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

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 16, 2007
Enrollment StartDec 1, 2007
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.6 years ago

Interventions

bevacizumab [Avastin]drug

15mg/kg iv on day 1 of each 3 week cycle

Docetaxeldrug

75mg/m2 iv on day 1 of each 3 week cycle

Standard chemotherapydrug

As prescribed