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A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
Sponsor: Hoffmann-La Roche
Summary
This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.
Official title: A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1050
Start Date
2023-12-11
Completion Date
2029-02-12
Last Updated
2026-09-14
Healthy Volunteers
No
Interventions
Giredestrant
Giredestrant 30 milligrams (mg) orally (PO) once a day (QD) on Days 1-28 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity.
Fulvestrant
Fulvestrant 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent 28-day cycle until PD or unacceptable toxicity.
Abemaciclib
If chosen by the investigator as the CDK4/6i, participants will receive abemaciclib 150 mg PO twice per day (BID) on Days 1-28 of each 28-day cycle until PD or unacceptable toxicity.
Palbociclib
If chosen by the investigator as the CDK4/6i, participants will receive palbociclib 125 mg PO QD on Days 1-21 of each 28-day cycle until PD or unacceptable toxicity.
Ribociclib
If chosen by the investigator as the CDK4/6i, participants will receive ribociclib 600 mg PO QD on Days 1-21 of each 28-day cycle until PD or unacceptable toxicity.
LHRH Agonist
Only pre/perimenopausal female participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer on Day 1 of each 28-day treatment cycle.
FoundationOne Liquid CDx Assay (F1LCDx)
F1LCDx is a next-generation sequencing (NGS)-based in vitro diagnostic test that detects and analyses genomic alterations in circulating cell-free DNA (cfDNA) isolated from plasma derived from the anti-coagulated peripheral whole blood of cancer patients. It will be used to determine the eligibility of participants requiring confirmation of ESR1 mutation status (mutation detected \[ESR1m\] vs. no mutation detected \[ESR1nmd\]).
Locations (311)
Southern Cancer Center
Daphne, Alabama, United States
Marin Cancer Care Inc
Greenbrae, California, United States
Kaiser Permanente - Harbor City
Harbor City, California, United States
Oncura Health
Los Angeles, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
Torrance, California, United States
Rocky Mountain Cancer Centers
Littleton, Colorado, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
MedStar Washington Hosp Center
Washington D.C., District of Columbia, United States
AdventHealth Altamonte
Altamonte Springs, Florida, United States
Florida Cancer Specialists - Broadway
Fort Myers, Florida, United States
Cancer Specialists of North Florida
Jacksonville, Florida, United States
Florida Cancer Specialists - North;725 6th Ave South (St. Petersburg)
St. Petersburg, Florida, United States
Comprehensive Hematology Oncology
St. Petersburg, Florida, United States
Florida Cancer Specialists - EAST - SCRI - PPDS
West Palm Beach, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Baptist Health Louisville
Louisville, Kentucky, United States
New England Cancer Specialists
Scarborough, Maine, United States
Maryland Oncology Hematology
Annapolis, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
HCA Midwest Division
Kansas City, Missouri, United States
Oncology Hematology West - Grand Island
Grand Island, Nebraska, United States
Oncology Hematology West - Legacy
Omaha, Nebraska, United States
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, United States
Duke Women Cancer Care
Raleigh, North Carolina, United States
Asante Rogue Regional Medical Center
Medford, Oregon, United States
Alliance Cancer Specialists
Bensalem, Pennsylvania, United States
Ann B. Barshinger Cancer Institute
Lancaster, Pennsylvania, United States
Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit
Philadelphia, Pennsylvania, United States
Brown University Health
Providence, Rhode Island, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
West Cancer Center
Germantown, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Texas Oncology Cancer Center
Austin, Texas, United States
Texas Oncology - DFW
Irving, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia, United States
Northwest Medical Specialties
Tacoma, Washington, United States
West Virginia University Hospitals Inc
Morgantown, West Virginia, United States
Centro de Investigaciones Médicas y Desarrollo LC S.R.L
Buenos Aires, Argentina
Inst. de Oncologia Angel H. Roffo
Buenos Aires, Argentina
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, Argentina
Sanatorio Allende
Córdoba, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, Argentina
Hospital Alemán
Recoleta, Argentina
Instituto de Oncología de Rosario
Rosario, Argentina
Hospital Provincial del Centenario
Rosario, Argentina
Centro Oncológico de Excelencia
San Juan, Argentina
Northern Beaches Hospital
Frenchs Forest, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
Mater Hospital
North Sydney, New South Wales, Australia
Sunshine Coast Haematology and Oncology Clinic
Buderim, Queensland, Australia
Mater Misericordiae Limited
South Brisbane, Queensland, Australia
Cancer Research SA
Adelaide, South Australia, Australia
Barwon Health
Geelong, Victoria, Australia
Sunshine Hospital
St Albans, Victoria, Australia
Lkh-Univ. Klinikum Graz
Graz, Austria
Ordensklinikum Linz Barmherzige Schwestern
Linz, Austria
Oö. Gesundheits- und Spitals-AG/LKH Steyr
Steyr, Austria
Cliniques Universitaires St-Luc
Brussels, Belgium
UZ Gent
Ghent, Belgium
UZ Leuven Gasthuisberg
Leuven, Belgium
CHU de Liège (Sart Tilman)
Liège, Belgium
Clinique Ste-Elisabeth
Namur, Belgium
ZAS Sint Augustinus Wilrijk
Wilrijk, Belgium
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, Brazil
CEDOES - Diagnóstico e Pesquisa
Vitória, Espírito Santo, Brazil
Obras Sociais Irma Dulce - Osid
Salvador, Estado de Bahia, Brazil
Hospital Sírio-Libanês
Brasília, Federal District, Brazil
Hospital Araujo Jorge
Goiânia, Goiás, Brazil
Hospital Sao Domingos
São Luís, Maranhão, Brazil
Hospital do Câncer de Londrina
Londrina, Paraná, Brazil
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, Brazil
Vencer Oncoclínica - Centro de Pesquisa do Piauí
Teresina, Piauí, Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
Hospital Amaral Carvalho
Jaú, São Paulo, Brazil
Hospital Sírio-Libanês
São Paulo, São Paulo, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, Brazil
Hospital A. C. Camargo
São Paulo, São Paulo, Brazil
Instituto D'Or de Pesquisa e Ensino
Rio de Janeiro, Brazil
Cross Cancer Institute
Edmonton, Alberta, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre
Mississauga, Ontario, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
North York General Hospital
Toronto, Ontario, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital
Chicoutimi, Quebec, Canada
CISSS Chaudière-Appalaches
Lévis, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
CHU de Québec - Hôpital du Saint-Sacrement
Québec, Quebec, Canada
Hopital regional de saint jerome
Saint-Jérôme, Quebec, Canada
Centre hospitalier regional de Trois-Rivieres
Trois-Rivières, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada