MedTrace Logo

Molecular Triaging of Newly Diagnosed Breast Cancer

NCT01159236 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2012-07-31

No results posted yet for this study

Summary

The goal of this clinical research study is to learn if using "gene signatures" can be an effective way to decide the best treatment for breast cancer patients. Gene signatures may be able to help researchers predict who will respond to chemotherapy given before surgery.

Conditions

Interventions

DRUG

Paclitaxel

80 mg/m2 by vein over about 1-2 hours once every 7 days x 12 courses.

DRUG

Fluorouracil

500 mg/m2 for 4 courses (once every 7 days)

DRUG

Doxorubicin

50 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments

DRUG

Epirubicin

100 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments, may be given instead of Doxorubicin in Group 1 and 2.

DRUG

Cyclophosphamide

500 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments.

DRUG

Bevacizumab

10 mg/kg intravenously every 2 weeks, discontinued 6 weeks before surgery (i.e. after 3rd course of FEC or FAC)

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Lajos Pusztai, MD, DPHIL · UT MD Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30

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 NCT01159236 on ClinicalTrials.gov