Phase II Trial Of Fulvestrant (Faslodex) In Women With Metastatic Breast Cancer And Failure on Aromatase Inhibitor 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.
PROJECTED ACCRUAL: Approximately 41-94 patients will be accrued for this study within 10
months.
Interventional
Primary Purpose: Treatment
James N. Ingle, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000068473
NCT00012025
May 2001
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
Allegheny General Hospital | Pittsburgh, Pennsylvania 15212-4772 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Mayo Clinic | Jacksonville, Florida 32224 |
Medcenter One Health System | Bismarck, North Dakota 58501 |
Altru Cancer Center | Grand Forks, North Dakota 58206 |
CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale, Arizona 85259 |
Carle Foundation Hospital - Carle Cancer Center | Urbana, Illinois 61801 |