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)

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.

Trial Details

NCT ID
NCT06065748
Phase
PHASE3
Sponsor
Hoffmann-La Roche
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • Giredestrant
  • Fulvestrant
  • Abemaciclib
  • Palbociclib
  • Ribociclib
  • LHRH Agonist
Locations (sample)
  • Daphne, Alabama, United States|30.60353,-87.9036
  • Auburn, California, United States|38.89657,-121.07689
  • Glendale, California, United States|34.14251,-118.25508
  • Greenbrae, California, United States|37.94854,-122.5247
  • Harbor City, California, United States|33.79002,-118.29785

Key Eligibility Criteria

  • 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 sam…
  • 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…

For full eligibility, visit ClinicalTrials.gov.

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