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)
- Conditions
- Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
- Registration Number
- NCT06065748
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1050
Inclusion Criteria:<br><br> - Locally advanced or metastatic adenocarcinoma of the breast, not amenable to<br> treatment with curative intent<br><br> - Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed<br> locally on the most recent tumor biopsy (or an archived tumor sample if a recent<br> tumor sample is not available for testing)<br><br> - Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor<br> DNA (ctDNA) through central laboratory testing<br><br> - Resistance to prior adjuvant endocrine therapy (ET). Prior use of neo/adjuvant<br> CDK4/6i is allowed.<br><br> - No prior systemic anti-cancer therapy for advanced disease<br><br> - Measurable disease as defined per RECIST v.1.1 or non-measurable (including<br> bone-only) disease<br><br> - Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1<br><br> - For pre/perimenopausal women and for men: willing to undergo and maintain treatment<br> with approved LHRH agonist therapy (as per local guidelines) for the duration of<br> study treatment<br><br>Exclusion Criteria:<br><br> - Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic<br> therapy) for locally advanced unresectable or metastatic breast cancer<br><br> - Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel<br> ER-targeting agents<br><br> - Advanced, symptomatic, visceral spread that is at risk of life-threatening<br> complications in the short term<br><br> - Active cardiac disease or history of cardiac dysfunction<br><br> - Clinically significant history of liver disease
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) in the ESR1 mutation (ESR1m) Subgroup;PFS in the Full Analysis Set (FAS) Population
- Secondary Outcome Measures
Name Time Method PFS in the ESR1 no-mutation-detected (ESR1nmd) Subgroup;Overall Survival (OS);Confirmed Objective Response Rate (cORR);Duration of Response (DOR);Clinical Benefit Rate (CBR);Time to Chemotherapy;Time to Confirmed Deterioration (TTCD) in Pain Severity;TTCD in Pain Presence and Interference;TTCD in Physical Functioning;TTCD in Role Functioning;TTCD in Global Health Status/Quality of Life;Incidence and Severity of Adverse Events;Number of Participants with Vital Sign Abnormalities Over the Course of the Study;Number of Participants with Clinical Laboratory Test Abnormalities for Hematology and Biochemistry Parameters Over the Course of the Study