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Docetaxel Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer

NCT00343512 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2012-04-27

Study results available
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Summary

RATIONALE: Dose-dense scheduling with (peg)filgrastim support may improve the clinical and pathologic complete response rate (pCR) and safety profile of single agent neoadjuvant docetaxel therapy.

PURPOSE: To evaluate whether dose-dense scheduling with (peg)filgrastim support may improve the clinical and pathologic complete response rate (pCR) and safety profile of single agent neoadjuvant docetaxel therapy. To determine the changes in molecular markers that occurs with single agent docetaxel, tissue will be obtained at the end of the four cycles of docetaxel (either by repeat biopsy or definitive surgery).

Conditions

Interventions

DRUG

docetaxel

Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles

GENETIC

protein expression analysis

protein expression analysis

OTHER

laboratory biomarker analysis

laboratory biomarker analysis

PROCEDURE

biopsy

biopsy

PROCEDURE

conventional surgery

conventional surgery

PROCEDURE

neoadjuvant therapy

neoadjuvant therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • A. Bapsi Chakravarthy, MD · Vanderbilt-Ingram Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2008-03-31
Completion
2011-03-31

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 NCT00343512 on ClinicalTrials.gov