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 now · Phase 3

Conditions studied: Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer

In brief

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.

Key facts

Study ID

NCT06065748

Run by

Hoffmann-La Roche

People needed

1050

Starts

2023-12-11

Expected to finish

2029-02-12

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• New England Cancer Specialists — Scarborough, Maine, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Baptist Health Hamburg — Lexington, Kentucky, United States (enrolling)
• Baptist Health Louisville — Louisville, Kentucky, United States (enrolling)
• Maryland Oncology Hematology — Annapolis, Maryland, United States (enrolling)
• La Hematology Oncology Medical Group — Glendale, California, United States (enrolling)
• Marin Cancer Care Inc — Greenbrae, California, United States (enrolling)
• Southern Cancer Center — Daphne, Alabama, United States (enrolling)
• Kaiser Permanente - Harbor City — Harbor City, California, United States (enrolling)
• Rocky Mountain Cancer Centers — Littleton, Colorado, United States (enrolling)
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• MedStar Washington Hosp Center — Washington D.C., District of Columbia, United States (enrolling)
• AdventHealth Altamonte — Altamonte Springs, Florida, United States (enrolling)
• Florida Cancer Specialists - Broadway — Fort Myers, Florida, United States (enrolling)
• Cancer Specialists of North Florida — Jacksonville, Florida, United States (enrolling)
• Florida Cancer Specialists - North;725 6th Ave South (St. Petersburg) — St. Petersburg, Florida, United States (enrolling)
• Comprehensive Hematology Oncology — St. Petersburg, Florida, United States (enrolling)
• Florida Cancer Specialists - EAST - SCRI - PPDS — West Palm Beach, Florida, United States (enrolling)
• The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente — Torrance, California, United States (enrolling)
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States (enrolling)
• Advocate Lutheran General Hospital — Park Ridge, Illinois, United States (enrolling)
• Springfield Clinic — Springfield, Illinois, United States (enrolling)
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• Baptist Health Lexington — Lexington, Kentucky, United States (enrolling)
• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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