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)
Recruiting · NCT06065748 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
AbemaciclibFoundationOne Liquid CDx Assay (F1LCDx)FulvestrantGiredestrantLHRH AgonistPalbociclibRibociclib
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
- Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or an archived tumor sample if a recent tumor sample is not available for testing)
- Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing
- Resistance to prior adjuvant endocrine therapy (ET), which is defined as having relapsed with prior standard adjuvant ET, on-treatment after \>/=12 months or off-treatment within 12 months of completion. Prior use of adjuvant CDK4/6i is allowed (if relapse occurred \>/=12 months since completion).
- No prior systemic anti-cancer therapy for advanced disease
- Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
- For pre/perimenopausal women and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy (as per local guidelines) for the duration of study treatment
Exclusion criteria
- Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer
- Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents
- Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
- Active cardiac disease or history of cardiac dysfunction
- Clinically significant history of liver disease
Where it is running
60 locations listed across 30 US states.
- Southern Cancer Center - Daphne, Alabama, United States
- Sutter Auburn Faith Hospital - Auburn, California, United States
- La Hematology Oncology Medical Group - Glendale, California, United States
- Marin Cancer Care Inc - Greenbrae, California, United States
- Kaiser Permanente - Harbor City - Harbor City, California, United States
- USC Norris Comprehensive Cancer Center - Los Angeles, California, United States
- USC Norris Cancer Center - Newport Beach, California, United States
- Sutter Medical Group, Roseville Clinic - Roseville, California, United States
- Sutter Health Medical Center - Sacramento, 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
- Grady Health System - Atlanta, Georgia, United States
- Winship Cancer Institute of Emory University - Atlanta, Georgia, United States
- Advocate Lutheran General Hospital - Park Ridge, Illinois, United States
- Springfield Clinic - Springfield, Illinois, United States
- Mission Cancer + Blood - IMMC - Des Moines, Iowa, United States
- Baptist Health Lexington - Lexington, Kentucky, United States
- Baptist Health Hamburg - Lexington, Kentucky, United States
- Baptist Health Louisville - Louisville, Kentucky, United States
- New England Cancer Specialists - Scarborough, Maine, United States
- Maryland Oncology Hematology - Annapolis, Maryland, United States
- Frederick Health Hospital - Frederick, 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
- Cancer Care Center of O'Fallon - O'Fallon, 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
- Capital Health Regional Medical Center - Pennington, New Jersey, United States
- Queens Hospital Cancer Center - Jamaica, New York, United States
- Duke Women Cancer Care - Raleigh, North Carolina, United States
- Oncology Hematology Care - Cincinnati, Ohio, 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
- WellSpan Oncology Research - York, Pennsylvania, United States
- Brown University Health - Providence, Rhode Island, United States
- Medical University of South Carolina - Charleston, South Carolina, United States
- Avera Cancer Institute - Aberdeen - Aberdeen, South Dakota, 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
- JPS Oncology & Infusion Center - Fort Worth, 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
- Aurora BayCare Medical Center - Green Bay, Wisconsin, United States
Showing 60 of 352 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →