CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
Standard chemotherapy +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/NCT00717405
NCT00717405Phase 2Completed
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An Open Label Study to Assess the Rate of Pathological Complete Response in Patients With Primary Inflammatory HER2-positive Breast Cancer Treated With Avastin + Herceptin Based Chemotherapy

Hoffmann-La Roche·interventional·Posted Jul 17, 2008·Updated Aug 2, 2016

In Brief

A Phase 2 clinical trial evaluating Standard chemotherapy, bevacizumab [Avastin], and 1 other intervention for Breast Cancer. Completed, enrolled 52 participants across 28 sites.

Detailed Summary

This single arm study will assess the efficacy and safety of preoperative treatment with Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of pre-operative chemotherapy + Avastin + Herceptin. 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
CountriesFrance
Collaborators--

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 17, 2008
Enrollment StartOct 1, 2008
Primary CompletionApr 1, 2010
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.0 years ago

Interventions

Standard chemotherapydrug

As prescribed

bevacizumab [Avastin]drug

15mg/kg iv 3 weekly in cycles 1-8

trastuzumab [Herceptin]drug

8mg/kg iv loading dose followed by 6mg/kg iv 3 weekly in cycles 5-8.