Status:
RECRUITING
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)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 12 2029
Estimated Enrollment :
1050 Patients enrolled
Trial Details
Trial ID
NCT06065748
Start Date
December 11 2023
End Date
February 12 2029
Last Update
December 17 2025
Active Locations (351)
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1
Southern Cancer Center
Daphne, Alabama, United States, 36526
2
Sutter Auburn Faith Hospital
Auburn, California, United States, 95602
3
La Hematology Oncology Medical Group
Glendale, California, United States, 91260
4
Marin Cancer Care Inc
Greenbrae, California, United States, 94904