Taxotere Plus Weekly Navelbine and G-CSF: A Study in Stage IV Breast Cancer

NCT00194740 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2007-12-06

No results posted yet for this study

Summary

The two drugs used to treat metastatic breast cancer in this study may perform better when used together than when used separately. The use of another drug that prevents the most common side effect of the two-drug combination permits the delivery of both agents at closer to the "full" dose for either when used alone. We hypothesize that the two-drug combination used with G-CSF support will be more effective and less toxic than other standard regimens for the treatment of metastatic breast cancer.

Conditions

  • Breast Neoplasm

Interventions

DRUG

Docetaxel

60 mg/m2, IV, day 1 of each 21 day cycle

DRUG

Vinorelbine

27.5 mg/m2, IV, days 8 \& 15 of each 21 day cycle

DRUG

Filgrastim

5 µg/kg/day s.c., to be administered days 2-21 of each cycle.

Sponsors & Collaborators

Principal Investigators

  • Julie R. Gralow, M.D. · University of Washington

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-11-30
Completion
2007-06-30

Countries

  • United States

Study Locations

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Entities

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 NCT00194740 on ClinicalTrials.gov