Phase III Study of Gemcitabine Plus Paclitaxel Versus Paclitaxel in Patients With Unresectable, Locally Recurrent or Metastatic Breast Cancer
OBJECTIVES: I. Compare overall survival of patients with unresectable, locally recurrent, or
metastatic breast cancer treated with paclitaxel with or without gemcitabine.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms. Patients receive paclitaxel with or without gemcitabine. Treatment continues
every 21 days in the absence of disease progression. Patients are followed every 2-4 months
for 2 years after active treatment.
PROJECTED ACCRUAL: Not specified
National Cancer Institute (NCI) registered this trial with Eli Lilly as sponsor. NCI did
not update the record when the trial completed. In June 2012, NCI transferred the trial to
Lilly's clinicaltrials.gov account and Lilly updated the record with the trial completion
date. This trial is not an applicable trial under Food and Drug Administration Amendments
Act of 2007 (FDAAA).
Interventional
Primary Purpose: Treatment
Furhan Yunus, MD, FACP
Study Chair
University of Tennessee
United States: Federal Government
2017
NCT00006459
July 2000
October 2005
Name | Location |
---|---|
University of Colorado Cancer Center | Denver, Colorado 80262 |
Comprehensive Cancer Institute of Huntsville | Huntsville, Alabama 35801 |
Mountain States Tumor Institute | Boise, Idaho 83712 |
Southwest Regional Cancer Center | Austin, Texas 78705 |
Overlook Hospital | Summit, New Jersey 07902-0220 |
Interlakes Oncology/Hematology PC | Rochester, New York 14623 |
Arlington Cancer Center | Arlington, Texas 76012 |
University of Tennessee, Memphis | Memphis, Tennessee 38163 |
Pacific Coast Hematology/Oncology Medical Group | Fountain Valley, California 92708 |
Mercy Hospital | Miami, Florida 33133 |
Oklahoma Oncology Inc. | Tulsa, Oklahoma 74104 |
Carle Cancer Center | Urbana, Illinois 61801 |
HemOnCare, P.C. | Brooklyn, New York 11235 |
St. John's Mercy Medical Center | Saint Louis, Missouri 63141 |
Memorial Medical Center | Springfield, Illinois 62781 |
Comprehensive Cancer Care Specialists of Boca Raton | Boca Raton, Florida 33428 |
APN-IMPATH Research Corporation | Fort Lee, New Jersey 07024 |
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group | Memphis, Tennessee 38119 |
N.W. Carolina Oncology & Hematology, P.A. | Hickory, North Carolina 28603 |
Intermountain Hematology/Oncology Associates, Inc. | Salt Lake City, Utah 84124 |
North Mississippi Hematology and Oncology Associates, Ltd. | Tupelo, Mississippi 38801 |
Little Rock Hematology-Oncology Associates | Little Rock, Arkansas 72205 |
Office of Alex J.P. Makalinao | Los Angeles, California 90045 |
Hematology/Oncology Group | Santa Rosa, California 95403 |
Danbury Internal Medicine | Danbury, Connecticut 06810 |
Indiana Community Cancer Care, Inc. | Indianapolis, Indiana 46202 |
Cancer Health Associates | Michigan City, Indiana 46360 |
Rittenhouse Hematology/Oncology | Philadelphia, Pennsylvania 19146 |
South Carolina Oncology Associates | Columbia, South Carolina 29201 |
Office Of C. Michael Jones | Germantown, Tennessee 38138 |
Northern Virginia Oncology Group, P.C. | Fairfax, Virginia 22031 |