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Back|NCT06065748Recruiting
Official Title

A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy

Phase
Phase 3
Sponsor
Hoffmann-La Roche
Enrollment
1,050
Timeline
Dec 2023 → Feb 2029
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.

Eligibility Criteria

Inclusion Criteria

  • 1Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
  • 2Documented 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)
  • 3Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing
  • 4Resistance 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).
  • 5No prior systemic anti-cancer therapy for advanced disease
  • 6Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease
  • 7Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
  • 8For 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 Criteria

  • 1Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer
  • 2Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents
  • 3Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
  • 4Active cardiac disease or history of cardiac dysfunction
  • 5Clinically significant history of liver disease

Locations

351 sites participating in this study

Winship Cancer Institute of Emory University

Atlanta, Georgia 30329

Recruiting

Southern Cancer Center

Daphne, Alabama 36526

Recruiting

Sutter Auburn Faith Hospital

Auburn, California 95602

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →