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Phase III Study of Gemcitabine Plus Paclitaxel Versus Paclitaxel in Patients With Unresectable, Locally Recurrent or Metastatic Breast Cancer

Phase 3
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

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.


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 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).

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven unresectable, locally
recurrent, or metastatic breast cancer not amenable to surgery or radiotherapy of curative
intent No inflammatory breast cancer unless evidence of metastatic disease No bone
metastases, pleural effusion, or ascites as the only site of disease Clinically measurable
disease outside previously irradiated area Relapse after 1 prior adjuvant or neoadjuvant
chemotherapy regimen containing anthracycline unless clinically contraindicated No known
or suspected brain metastases or recurrence requiring steroids or radiotherapy Hormone
receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified
Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic:
Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3
Hemoglobin at least 9.0 g/dL Hepatic: ALT and AST no greater than 2 times upper limit of
normal (ULN) Bilirubin no greater than 1.5 times ULN Renal: Calcium no greater than 1.2
times ULN Creatinine no greater than 1.5 times ULN Cardiovascular: No active uncontrolled
cardiac disease and/or myocardial infarction within the past 6 months Other: Not pregnant
or nursing Negative pregnancy test Fertile patients must use effective contraception
during and for 3 months after completion of study No other prior malignancy within the
past 5 years except adequately treated basal cell or squamous cell skin cancer or
carcinoma in situ of the cervix No other serious systemic disorder precluding study No
active infection No severe psychiatric disease No history of hypersensitivity reactions to
polyoxyethylated castor oil-based drugs

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation or
autologous stem cell infusion following high-dose adjuvant chemotherapy for metastatic
disease No concurrent immunotherapy (including humanized anti-HER2 antibody) Chemotherapy:
See Disease Characteristics See Biologic therapy No prior chemotherapy for metastatic
breast cancer No prior gemcitabine or taxane No other concurrent chemotherapy Endocrine
therapy: See Disease Characteristics Prior antitumoral hormonal therapy allowed No
concurrent hormonal therapy excluding contraceptives and replacement steroids
Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy and
recovered No concurrent radiotherapy Surgery: See Disease Characteristics Other: Recovered
from prior therapy At least 30 days since prior investigational drugs No concurrent
investigational drugs Concurrent bisphosphonate therapy allowed if not begun or stopped
within 4 weeks before study

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Furhan Yunus, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Tennessee


United States: Federal Government

Study ID:




Start Date:

July 2000

Completion Date:

October 2005

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • recurrent breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms



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