CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 76 enrolled
Drug / intervention
filgrastim +3 morebiological
Likely dose
Trastuzumab weekly; docetaxel and vinorelbine with filgrastim supportAI-extracted
Key inclusion· 6
  • Histologically confirmed stage IV breast cancer
  • HER2-positive by FISH or immunohistochemistry 3+ staining
  • Female, age 18 and over
  • Zubrod performance status 0-2
Key exclusion· 8
  • No primary or metastatic brain or CNS tumors
  • Effusions or ascites as only sites of disease
  • Prior docetaxel or vinorelbine
  • More than 1 prior adjuvant or neoadjuvant chemotherapy regimen

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00041067
NCT00041067Phase 2Completed

Docetaxel (NSC-628503) And Vinorelbine (NSC-608210) Plus Filgrastim (NSC-614629) With Weekly Trastuzumab (NSC-688097) For HER-2 Positive, Stage IV Breast Cancer

SWOG Cancer Research Network·interventional·Posted Jan 27, 2003·Updated Jun 6, 2013

In Brief

A Phase 2 clinical trial evaluating filgrastim, trastuzumab, and 2 other interventions for Breast Cancer. Completed, enrolled 76 participants across 145 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors, such as filgrastim, may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with docetaxel, vinorelbine, and filgrastim in treating women who have stage IV breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartSep 1, 2002
Primary CompletionJan 1, 2008
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 23.4 years ago

Interventions

filgrastimbiological

trastuzumabbiological

docetaxeldrug

vinorelbinedrug