Last updated 14 days ago
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)
1050 patients around the world
Available in Costa Rica, Argentina, United States, Guatemala, Colombia, Chile, Brazil
Hoffmann-La Roche
12Research sites
1050Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 archived tumor sample).Confirmed ESR1 mutation status (ESR1m vs. ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing.Resistance to prior adjuvant endocrine therapy (ET). Prior use of neo/adjuvant CDK4/6i is allowed.No prior systemic anti-cancer therapy for advanced disease.Measurable disease as defined per RECIST v.1.1 or non-measurable bone-only disease.Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1.For pre/perimenopausal women and for men: treatment with LHRH agonist therapy (as per local guidelines) for the duration of study treatment is required.
- 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.
Sites
Hospital Provincial del Centenario - Rosario, Santa Fe
Recruiting
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
Sanatorio Parque - Rosario
Recruiting
Centro Oncológico de Excelencia - COE San Juan
Recruiting
Sanatorio Allende (Nueva Córdoba)
Recruiting
Instituto de Oncología Ángel H. Roffo - CABA, Buenos Aires
Recruiting
Centro Oncológico Korben
Recruiting
Fundación CENIT para la Investigación en Neurociencias
Recruiting
Instituto de Oncología de Rosario - IOR
Recruiting
Hospital Alemán
Recruiting
StudyPionERA
SponsorHoffmann-La Roche
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06065748
