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Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer
Sponsor: National Cancer Institute (NCI)
Summary
This randomized phase III trial studies tamoxifen citrate or letrozole together with bevacizumab to see how well it works compared with tamoxifen citrate or letrozole alone in treating women with stage IIIB or stage IV breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Immunotherapy with monoclonal antibodies, such as bevacizumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving hormone therapy is more effective with or without bevacizumab in treating advanced breast cancer.
Official title: Endocrine Therapy With or Without Anti-VEGF Therapy: A Randomized, Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab (NSC 704865) for Women With Hormone Receptor-Positive Advanced Breast Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
394
Start Date
2008-09-24
Completion Date
2024-01-29
Last Updated
2026-08-28
Healthy Volunteers
No
Conditions
Interventions
Bevacizumab
Given IV
Laboratory Biomarker Analysis
Correlative studies
Letrozole
Given PO
Questionnaire Administration
Ancillary studies
Tamoxifen Citrate
Given PO
Locations (522)
Providence Hospital
Mobile, Alabama, United States
Sparks Regional Medical Center
Fort Smith, Arkansas, United States
East Bay Medical Oncology Hematology Medical Associates-Antioch
Antioch, California, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
Mills-Peninsula Medical Center
Burlingame, California, United States
East Bay Radiation Oncology Center
Castro Valley, California, United States
Eden Hospital Medical Center
Castro Valley, California, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, United States
Adventist Health Cancer Care Center Chico
Chico, California, United States
Community Cancer Institute
Clovis, California, United States
Bay Area Breast Surgeons Inc
Emeryville, California, United States
Valley Medical Oncology Consultants-Fremont
Fremont, California, United States
Marin General Hospital
Greenbrae, California, United States
Los Angeles General Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
Fremont - Rideout Cancer Center
Marysville, California, United States
Memorial Medical Center
Modesto, California, United States
El Camino Hospital
Mountain View, California, United States
Sutter Cancer Research Consortium
Novato, California, United States
Highland General Hospital
Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
Bay Area Tumor Institute
Oakland, California, United States
Hematology and Oncology Associates-Oakland
Oakland, California, United States
Tom K Lee Inc
Oakland, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
East Bay Medical Oncology Hematology Medical Associates Inc-Pleasant Hill
Pleasant Hill, California, United States
John Muir Health Cancer Medical Group
Pleasant Hill, California, United States
Valley Care Health System - Pleasanton
Pleasanton, California, United States
Valley Medical Oncology Consultants
Pleasanton, California, United States
Pomona Valley Hospital Medical Center
Pomona, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Zuckerberg San Francisco General Hospital
San Francisco, California, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
UCSF Medical Center-Mount Zion
San Francisco, California, United States
East Bay Medical Oncology Hematology Associates Inc
San Leandro, California, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, United States
Saint Helena Hospital
St. Helena, California, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, United States
Northbay Cancer Center
Vacaville, California, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Boulder Community Hospital
Boulder, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
AdventHealth Porter
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Western States Cancer Research NCORP
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States
Banner North Colorado Medical Center
Greeley, Colorado, United States
Saint Anthony Hospital
Lakewood, Colorado, United States
AdventHealth Littleton
Littleton, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Longmont United Hospital
Longmont, Colorado, United States
Banner McKee Medical Center
Loveland, Colorado, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States
North Suburban Medical Center
Thornton, Colorado, United States
Intermountain Health Lutheran Hospital
Wheat Ridge, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
Middlesex Hospital
Middletown, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut, United States
Beebe Medical Center
Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Boca Raton Regional Hospital
Boca Raton, Florida, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Florida Cancer Specialists-Gainesville Cancer Center
Gainesville, Florida, United States
Jupiter Medical Center
Jupiter, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
University Cancer and Blood Center LLC
Athens, Georgia, United States
Piedmont Hospital
Atlanta, Georgia, United States
Atlanta Regional CCOP
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
Augusta University Medical Center
Augusta, Georgia, United States
WellStar Cobb Hospital
Austell, Georgia, United States
John B Amos Cancer Center
Columbus, Georgia, United States
Emory Decatur Hospital
Decatur, Georgia, United States
Dublin Hematology Oncology Care PC
Dublin, Georgia, United States
Piedmont Fayette Hospital
Fayetteville, Georgia, United States
Eisenhower Army Medical Center
Fort Eisenhower, Georgia, United States
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, United States
Northside Hospital - Gwinnett
Lawrenceville, Georgia, United States
Atrium Health Navicent
Macon, Georgia, United States
Wellstar Kennestone Hospital
Marietta, Georgia, United States
Southern Regional Medical Center
Riverdale, Georgia, United States
Harbin Clinic Medical Oncology and Clinical Research
Rome, Georgia, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Straub Clinic and Hospital
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States