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Genetic Expression and Prediction of Response to Neoadjuvant Docetaxel or Doxorubicin in Locally Advanced Breast Cancer

NCT00123929 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2009-08-06

No results posted yet for this study

Summary

After a core biopsy of the tumor is obtained, patients with locally advanced breast cancer are randomized to receive 4 cycles of full dose doxorubicin (75 mg/m2 e3w) or docetaxel (100 mg/m2 e3w). After the fourth cycle, patients are submitted to surgery to ascertain pathological response. They then receive the opposite drug, hormones, Herceptin, and radiation as indicated.

Conditions

Interventions

DRUG

docetaxel

100 mg/m2 every 3 weeks times 4

DRUG

doxorubicin

75 mg/m2 every 3 weeks times 4

Sponsors & Collaborators

  • UNC Lineberger Comprehensive Cancer Center

    collaborator OTHER

  • Hospital San Carlos, Madrid

    lead OTHER

Principal Investigators

  • Eduardo Diaz-Rubio, MD, PhD · Servicio de Oncologia Medica, Hospital Universitario San Carlos, Madrid, Spain

  • Martin Miguel, MD, PhD · Hospital San Carlos, Madrid, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • 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 NCT00123929 on ClinicalTrials.gov