Study on Giredestrant vs. Fulvestrant with CDK4/6 Inhibitors for Advanced ER-Positive, HER2-Negative Breast Cancer Resistant to Hormone Therapy

Sponsor: Hoffmann-La Roche

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06065748

Provider View

This clinical trial is testing the effectiveness and safety of a new drug, giredestrant, compared to fulvestrant, both combined with a CDK4/6 inhibitor, in patients with advanced breast cancer that is resistant to hormone therapy.

Patient Parameters

Program Overview

This Phase III study is comparing two treatments for patients with advanced breast cancer that is estrogen receptor-positive (ER+) and HER2-negative (HER2-). The trial will test giredestrant against fulvestrant, both used with a CDK4/6 inhibitor chosen by the doctor. The study focuses on patients whose cancer has stopped responding to hormone therapy.

Eligibility Criteria

Inclusion Criteria

  • Have advanced breast cancer that cannot be cured with surgery.
  • Cancer must be ER-positive and HER2-negative, confirmed by recent or archived biopsy.
  • Have a specific genetic mutation (ESR1) confirmed by a blood test.
  • Cancer must have stopped responding to previous hormone therapy.
  • No previous treatment with systemic anti-cancer drugs for advanced cancer.
  • Have measurable or non-measurable disease, including bone-only disease.
  • Be in good general health with an ECOG performance status of 0 or 1.
  • Pre/perimenopausal women and men must agree to use hormone therapy as per local guidelines during the study.

Exclusion Criteria

  • Have had previous systemic treatment for advanced breast cancer.
  • Have used other similar drugs targeting estrogen receptors.
  • Have cancer that has spread to vital organs and is causing severe symptoms.
  • Have active heart disease or a history of heart problems.
  • Have a significant history of liver disease.

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