Study on Giredestrant and Everolimus Compared to Doctor's Choice of Hormone Therapy and Everolimus for Advanced Breast Cancer

Sponsor: Genentech, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05306340

Provider View

This clinical trial is testing the effectiveness and safety of a new treatment combination, giredestrant and everolimus, compared to the usual hormone therapy chosen by doctors, in patients with advanced breast cancer that is estrogen receptor-positive and HER2-negative.

Patient Parameters

Program Overview

This Phase III study is comparing two treatment options for patients with advanced breast cancer that is estrogen receptor-positive and HER2-negative. The study will look at how well giredestrant combined with everolimus works compared to the usual hormone therapy plus everolimus. Participants must have previously been treated with CDK4/6 inhibitors and hormone therapy for their cancer.

Eligibility Criteria

Inclusion Criteria

  • Have advanced breast cancer that cannot be surgically removed or has spread to other parts of the body.
  • Cancer must be estrogen receptor-positive and HER2-negative.
  • Able to provide a blood sample for testing specific cancer markers.
  • Previously treated with hormone therapy and CDK4/6 inhibitors, with specific conditions based on whether the treatment was for advanced cancer or as an additional therapy.
  • Have measurable cancer or bone metastases that can be tracked with scans.
  • Be in good overall health with a performance status score of 0 or 1.
  • Premenopausal or perimenopausal women and men must agree to use hormone therapy during the study.

Exclusion Criteria

  • Previously treated with certain types of hormone therapies or everolimus.
  • Cancer has progressed after more than two lines of hormone therapy for advanced cancer.
  • Previously received chemotherapy for advanced cancer.
  • Taking certain medications that affect liver enzymes within 14 days before starting the study.
  • Participated in another clinical trial within 28 days before starting the study.
  • Had major surgery or cancer treatment within 14 days before starting the study.
  • History of other cancers within the last 5 years, except for certain low-risk cancers.
  • Have severe cancer spread that could cause life-threatening complications soon.
  • Have uncontrolled or symptomatic brain cancer spread.
  • Have serious heart disease or history of heart problems.
  • Have significant liver disease or active hepatitis.
  • Have severe digestive issues or had major stomach surgery.
  • Have lung disease or need oxygen therapy.
  • Have a serious infection requiring antibiotics within 14 days before starting the study.
  • Have any serious medical condition that could affect safe participation in the study.
  • Have allergies to any study drugs or their ingredients.
  • Premenopausal or perimenopausal women and men with allergies to hormone therapy.
  • Pregnant or breastfeeding.

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