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COMPLETED
NCT00601900
PHASE3

Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Bevacizumab

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Letrozole

Given PO

OTHER

Questionnaire Administration

Ancillary studies

DRUG

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

And 422 more locations on ClinicalTrials.gov