RecruitingEstrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer

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)

Eligible age

18+ yrs

Accepts

All genders

Locations

30 states

Healthy volunteers

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About this study

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.

Sponsor: Hoffmann-La Roche

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