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A Study of Avastin (Bevacizumab) Plus Herceptin (Trastuzumab) in Patients With Primary Inflammatory HER2-Positive Breast Cancer.

NCT00717405 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2016-08-02

Study results available
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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.

Conditions

Interventions

DRUG

Standard chemotherapy

As prescribed

DRUG

bevacizumab [Avastin]

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

DRUG

trastuzumab [Herceptin]

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-04-30
Completion
2014-10-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00717405 on ClinicalTrials.gov