ICI 182780 in Treating Women With Metastatic Breast Cancer
- Registration Number
- NCT00012025
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description fulvestrant fulvestrant 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.
- Primary Outcome Measures
Name Time Method objective response rate Up to 10 years
- Secondary Outcome Measures
Name Time Method time to disease progression Up to 10 years overall survival Up to 10 years
Trial Locations
- Locations (25)
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
Altru Cancer Center
🇺🇸Grand Forks, North Dakota, United States
CCOP - Geisinger Clinic and Medical Center
🇺🇸Danville, Pennsylvania, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
Carle Foundation Hospital - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Medcenter One Health System
🇺🇸Bismarck, North Dakota, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States