MedTrace Logo

Randomized Clinical Trial to Evaluate the Predictive Accuracy of a Gene Expression for Stage I-II Breast Cancer

NCT00336791 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2012-02-14

No results posted yet for this study

Summary

Primary Objectives:

1. To prospectively evaluate the predictive accuracy of a previously discovered gene expression profile-based test to foretell pathologic complete response (pCR) to preoperative paclitaxel/FAC (5-fluorouracil, doxorubicin, cyclophosphamide) chemotherapy for stage I-III breast cancer.
2. To evaluate if our genomic predictive test is specific to the paclitaxel/FAC regimen or it also predicts increased sensitivity to FAC only chemotherapy.

Secondary Objectives:

1. To discover a molecular profile that is associated with pCR after FAC chemotherapy alone
2. To establish a prospectively collected gene expression profile data bank of breast cancer for future studies
3. To compare the pCR rates between patients who receive 6 courses FAC and those who receive sequential paclitaxel /FAC chemotherapies.

Conditions

Interventions

DRUG

5-Fluorouracil

FEC Chemotherapy: 500 mg/m\^2 IV on day 1 of 21 day cycle. FAC Chemotherapy: 500 mg/m\^2 IV on day 1 and day 4 of 21 day cycle.

DRUG

Cyclophosphamide

FAC and FEC Chemotherapy: 500 mg/m\^2 IV on day 1 of 21 day cycle.

DRUG

Doxorubicin

FAC Chemotherapy: 50 mg/m\^2 IV on day 1 over 72 hour continuous infusion or IV bolus.

DRUG

Paclitaxel

80 mg/m\^2 by vein (IVPB) over 1 hour every week for 12 weeks

DRUG

Epirubicin

FEC: 100 mg/m\^2 IV on day 1 of 21 day cycle.

Sponsors & Collaborators

  • Breast Cancer Research Foundation

    collaborator OTHER

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Lajos Pusztai, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2007-08-31
Completion
2010-09-30

Countries

  • United States
  • Mexico
  • Peru
  • Spain

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 NCT00336791 on ClinicalTrials.gov