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Neoadjuvant TAC Plus or Minus Bevacizumab(AVF3299)

NCT00203372 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2015-10-12

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety of the TAC-bevacizumab combination and investigate whether changes in gene expression, or the expression of specific biomarkers, are either predictive of response to bevacizumab or indicative of response.

Conditions

Interventions

DRUG

Bevacizumab 7.5 and TAC

Bevacizumab given intravenously at a dose of 7.5mg/kg every 3 weeks, followed by docetaxel, doxorubicin and cyclophosphamide (TAC).

DRUG

Placebo 7.5 and Docetaxel, Doxorubicin, and Cyclophosphamide (TAC)

placebo 7.5 will be adminitered intravenously every 3 weeks followed by TAC

DRUG

Bevacizumab 15 and TAC

one dose of Bevacizumab (15 mg/kg) will be administered intravenously every 3 weeks followed by TAC.

DRUG

Placebo 15 and TAC

one dose of placebo 15 will be administered intravenously every 3 weeks followed by TAC.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Translational Oncology Research International

    lead OTHER

Principal Investigators

  • Fairooz Kabbinavar, MD · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2012-06-30

Countries

  • United States
  • Canada
  • Ireland

Study Locations

More Related Trials

Entities

Diseases

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 NCT00203372 on ClinicalTrials.gov