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Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer

NCT00050167 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 603

Last updated 2011-08-29

Study results available
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Summary

Primary Objectives:

* Determine the impact of each regimen on the disease free and overall survival of patients with operable breast cancer.
* Determine the ability of docetaxel/capecitabine to downstage primary breast cancer when administered in the neoadjuvant setting when compared with weekly paclitaxel.
* Determine the ability of each regimen to enhance breast conservation therapy when administered in the neoadjuvant setting. (See protocol text for additional objectives and details).

Conditions

Interventions

DRUG

Paclitaxel

80 mg/m\^2 by vein (IV) Weekly Over 1 Hour x 12 Weeks

DRUG

Docetaxel

75 mg/m\^2 by vein (IV) Over 1 Hour Once Every 3 Weeks

DRUG

Capecitabine

1500 mg/m\^2 by mouth Twice Daily x 2 Weeks

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2008-07-31
Completion
2011-08-31

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 NCT00050167 on ClinicalTrials.gov