Study on Giredestrant vs. Doctor's Choice of Hormone Therapy for Advanced or Metastatic Breast Cancer
Sponsor: Hoffmann-La Roche
ClinicalTrials ID:NCT04576455
This clinical trial is testing the effectiveness and safety of a new drug, Giredestrant, compared to standard hormone therapy chosen by doctors for patients with advanced or metastatic breast cancer that is estrogen receptor-positive and HER2-negative.
Patient Parameters
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Program Overview
The study aims to find out if Giredestrant is more effective and safe compared to the usual hormone treatments chosen by doctors for patients with advanced or metastatic breast cancer that is estrogen receptor-positive and HER2-negative. Participants in this study have already received one or two previous treatments for their advanced cancer.
Eligibility Criteria
Inclusion Criteria
- Women who are postmenopausal or premenopausal/perimenopausal.
- Premenopausal or perimenopausal women and men must agree to use LHRH agonist therapy during the study.
- Have advanced breast cancer that cannot be cured with surgery.
- Cancer must be estrogen receptor-positive and HER2-negative.
- Cancer has worsened after one or two previous treatments for advanced cancer.
- Have measurable cancer or bone-only disease with at least one bone lesion that can be tracked by scans.
- Be in good overall health with an ECOG performance status of 0 or 1.
- Have good organ function.
Exclusion Criteria
- Have previously been treated with a selective estrogen receptor degrader (SERD), except for fulvestrant, if it was stopped at least 28 days before joining the study.
- Have taken any experimental treatments within 28 days before joining the study.
- Have advanced cancer that has spread to vital organs and is causing severe symptoms.
- Have uncontrolled or symptomatic cancer spread to the brain or spinal cord.
- Have active heart disease or a history of heart problems.
- Are pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Northwest Georgia Oncology Centers PC - Marietta | 30060 | Marietta | Georgia |
| University Hospitals Seidman Cancer Center | 44106 | Cleveland | Ohio |
| Northwest Cancer Specialists - Portland (SW Barnes Rd) | 97223 | Tigard | Oregon |
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