Comparing the Safety and Effectiveness of a New Hormonal Therapy in Patients with HER2-Negative, ER-Positive Early Breast Cancer

About the Study

This study is comparing safety and effectiveness of a new drug called giredestrant compared to standard hormone therapy in people with early-stage, ER-positive breast cancer. 

This study is no longer enrolling people.

What the Study Involves

This study involves two groups. In addition to the drugs listed in each group, participants will receive a drug to prevent the production of sex hormones. In men, this drug causes the testicles to stop making testosterone. In women, they cause the ovaries to stop making estrogen and progesterone.

Group 1

• Patients will receive Giredestrant orally once a day for five years, or until there is a recurrence of disease or the patient cannot tolerate the drug, whichever comes first.

Group 2

• Patients will receive the hormone therapy of the physician’s choice, either tamoxifen, letrozole, anastrozole, or exemestane, which will be given daily for five years, or until the disease recurs or the patient cannot tolerate the drug, whichever comes first.

Study Sites

Alabama

• Daphne
  Southern Cancer Center

California

• Bakersfield
  CBCC Global Research Inc., at Comprehensive Blood and Cancer Center
• Colton
  Arrowhead Regional Medical Center
• Fountain Valley
  Cancer and Blood Specialty Inc
• Fountain Valley
  Long Beach Memorial Medical Center
• Los Angeles
  USC Norris Cancer Center
• Orange
  The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
• Palo Alto
  Stanford University Medical Center
• Roseville
  Kaiser Permanente - Roseville
• San Diego
  Kaiser Permanente - San Diego
• San Francisco
  Kaiser Permanente - San Francisco
• San Jose
  Stanford Cancer Center South Bay
• Santa Barbara
  Sansum Clinic
• Santa Clara
  Kaiser Permanente - Santa Clara
• Santa Monica
  UCLA Hematology/Oncology
• Santa Rosa
  St. Joseph Heritage Healthcare
• Torrance
  Torrance Memorial Physician Network/Cancer Care
• Vallejo
  Kaiser Permanente - Vallejo
• Van Nuys
  Valley Breast Care and Women’s Health Center

Colorado

• Greeley
  Banner MD Anderson Cancer Center
• Longmont
  Rocky Mountain Cancer Centers (Longmont) - USOR

Connecticut

• Stamford
  Stamford Hospital; Clinical Trials Office - 1st Floor - Bennett Cancer Center

Florida

• Hollywood
  Memorial Healthcare System - Memorial Regional Hospital
• Jacksonville
  Baptist - MD Anderson Cancer Center
• Miami Beach
  Mount Sinai Comprehensive Cancer Center
• Miami
  Miami Cancer Institute of Baptist Health, Inc.
• Orlando
  Orlando Health Cancer Institute
• Plantation
  Miami Cancer Institute - Plantation

Georgia

• Savannah
  Memorial Health University Cancer Center

Illinois

• Chicago
  University of Illinois at Chicago
• Chicago
  University of Chicago Hospital
• Elmhurst
  Elmhurst Cancer Center
• Joliet
  Joliet Oncology Hematology Associates, Ltd
• Naperville
  Edward Cancer Center Naperville
• Plainfield
  Edward Cancer Center Plainfield

Iowa

• Cedar Rapids
• Oncology Associates at Mercy Medical Center
• Iowa City
  University of Iowa

Kansas

• Kingman
  Cancer Center of Kansas - Kingman

Kentucky

• Lexington
  Lahey Clinic Medical Center
• Lexington
  University of Kentucky; Markey Cancer Center
• Louisville 
  Norton Cancer Institute - MDC

Louisiana

• Baton Rouge
  Hematology/Oncology Clinic, LLP
• New Orleans
  University Medical Center New Orleans

Maryland

• Cumberland
  UPMC Western Maryland - Schwab Family Cancer Center
• Towson
  University of Maryland; St. Joseph Medical Center

Massachusetts

• Lexington
• Massachusetts General Hospital; Lurie Center for Autism

Michigan

• Ann Arbor
  University of Michigan
• Detroit
  Barbara Ann Karmanos Cancer Center

Minnesota

• Saint Louis Park
  Metro-Minnesota Community Oncology Research Consortium

Missouri

• Kansas City
  University of Missouri - Columbia; Ellis Fischel Cancer Center

Montana

• Billings
  St. Vincent Frontier Cancer Center

Nebraska

• Omaha
  Nebraska Cancer Specialists
• Omaha
  University of Nebraska Medical Center

Nevada

• Las Vegas
  Comprehensive Cancer Centers of Nevada

New Jersey

• Camden
  MD Anderson Cancer Center at Cooper
• Flemington
  Hunterdon Hematology Oncology
• New Brunswick
  Rutgers Cancer Institute of New Jersey

New York

• Buffalo
  Roswell Park Cancer Institute
• Jamaica
  Queens Hospital Cancer Center
• Mineola
  NYU Winthrop Hospital
• New York
  New York Cancer Center
• Stony Brook
  Stony Brook University Cancer Center

North Carolina

• Asheville
  Messino Cancer Centers
• Charlotte
  Levine Cancer Institute
• Pinehurst
  First Health of the Carolinas
• Raleigh
  Rex Cancer Center
• Rocky Mount
  UNC Cancer Center at Nash
• Winston-Salem
  Wake Forest Baptist Medical Center

Ohio

• Canton
  Aultman Hospital
• Cincinnati
  Oncology Hematology Care Inc
• Cleveland
  University Hospitals Cleveland Medical Center
• Cleveland
  Cleveland Clinic; Taussig Cancer Institute
• Columbus
  Columbus NCORP
• Columbus
  Stefanie Spielman Comprehensive Breast Cancer
• Columbus
  SCRI Mark H. Zangmeister Cancer Center

Oregon

• Portland
  Kaiser Permanente - Northwest Region
• Springfield
  Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute
• Tigard
  Northwest Cancer Specialists, P.C.

Pennsylvania

• Harrisburg
  Pinnacle Health
• Hershey
  Penn State University Milton S. Hershey Medical Center; Department of Investigational Drug Services
• Pittsburgh
  Allegheny Cancer Center
• Pittsburgh
  University of Pittsburgh Medical Center; Division of Hematology-Oncology
• West Reading
  Reading Hospital
• Williamsport
  UPMC Williamsport, Divine Providence Campus

Rhode Island

• Providence
  Women & Infants Hospital

South Dakota

• Sioux Falls
  Avera Cancer Institute

Tennessee

• Germantown
  West Cancer Center & Research Institute
• Nashville
  Tennessee Oncology NASH - SCRI - PPDS

Texas

• El Paso
  Texas Oncology, P.A. - El Paso; West
• Flower Mound
  Texas Oncology (Flower Mound) - USOR
• Fort Worth
  Texas Oncology - Fort Worth Cancer Center
• Houston
  Baylor College of Medicine Medical Center
• Houston
  Houston Methodist Cancer Center
• Lubbock
  Joe Arrington Cancer Research & Treatment Center
• McAllen
  Texas Oncology (McAllen) - USOR
• McKinney
  Texas Oncology McKinney
• San Antonio
  USOR - Texas Oncology - San Antonio Northeast
• The Woodlands
  US Oncology Research, Inc.
• Tyler
  Texas Oncology (Tyler) - USOR
• Waco
  Texas Oncology (Waco) - USOR

Virginia

• Lynchburg
  Lynchburg Hematology Oncology Clinic Inc
• Midlothian
  Bon Secours Mercy Health
• Norfolk
  Virginia Oncology Associates
• Richmond
  Virginia Commonwealth University - Massey Cancer Center
• Roanoke
  Oncology and Hematology Associates of Southwest Virginia, Inc., - Blacksburg

Washington

• Seattle
  Swedish Cancer Institute; IDS Pharmacy

West Virginia

• Morgantown
  West Virginia University Hospitals Inc

Wisconsin

• Madison
  University of Wisconsin
• Milwaukee
  Froedtert and the Medical College of Wisconsin