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Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer

NCT00038402 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2012-07-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy treatment of patients newly diagnosed with operable breast cancer.

Other objectives: 1) to evaluate the potential of this therapy to reduce the size of the tumor and increase the possibility of breast conservative surgery, 2) evaluate the ability of this regimen to prevent recurrence of breast cancer and impact on survival, 3) determine side effect profile with the addition of Herceptin, and 4) evaluate significance of HER2 expression by two different methods.

Conditions

Interventions

DRUG

Herceptin

Starting dose of 4 mg/kg by vein, then 2 mg/kg weekly after that until the end of all cycles of neo-adjuvant chemotherapy and during FEC therapy for a total of 24 doses.

DRUG

Taxol

225 mg/m\^2 by vein as a continuous infusion over 24 hours each cycle for a total of 4 cycles.

DRUG

Fluorouracil

500 mg/m\^2 by vein on Days 1 and 4 for 4 cycles at 3-4 week intervals.

DRUG

Cytoxan

500 mg/m\^2 on Day 1 of each cycle for 4 cycles.

DRUG

Epirubicin

75 mg/m\^2 IV on Day 1 of each cycle for 4 cycles.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Aman U Buzdar, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-04-30
Primary Completion
2004-11-30
Completion
2011-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT00038402 on ClinicalTrials.gov