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Phase II Trial Of Fulvestrant (Faslodex) In Women With Metastatic Breast Cancer And Failure on Aromatase Inhibitor Therapy
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 may fight breast cancer by blocking the activity of estrogen in the tumor cells. PURPOSE: Phase II trial to study the effectiveness of ICI 182780 in treating patients who have metastatic breast cancer that has not responded to previous hormone therapy.
OBJECTIVES: * Determine the complete and partial objective response rate and duration of response in women with metastatic breast cancer who have failed aromatase inhibitor therapy treated with fulvestrant. * Determine the time to disease progression and overall survival of women treated with this drug. * Determine the toxicity of this drug in these women. OUTLINE: Patients receive fulvestrant intramuscularly on day 1. Courses repeat approximately every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 5 years or until disease progression. After disease progression, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
MBCCOP - Gulf Coast
Mobile, Alabama, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Carle Foundation Hospital - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Siouxland Hematology-Oncology
Sioux City, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
Start Date
May 1, 2001
Primary Completion Date
March 1, 2006
Completion Date
August 1, 2008
Last Updated
July 6, 2016
80
ACTUAL participants
fulvestrant
DRUG
Lead Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
NCT05673200
NCT05372640
Data Source & Attribution
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