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

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

Clinicaltrials.gov identifier:
NCT04961996


Treatment study for people with early-stage breast cancer

Study Contact Information:

For additional information, please contact:

Hoffmann-La Roche by phone  (888) 662-6728 or searching by location online at https://forpatients.roche.com/  


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 , 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 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

 

This Study is Open To:

This study is no longer enrolling people.

 

This Study is Not Open To:

This study is no longer enrolling people.