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
ClinicalTrials ID:NCT06065748
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
| Parameter | Options |
|---|
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Southern Cancer Center | 36526 | Daphne | Alabama |
| La Hematology Oncology Medical Group | 91260 | Glendale | California |
| Marin Cancer Care Inc | 94904 | Greenbrae | California |
| Kaiser Permanente - Harbor City | 90710 | Harbor City | California |
| USC Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| USC Norris Cancer Center | 92663 | Newport Beach | California |
| Sutter Health Medical Center | 95816 | Sacramento | California |
| The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente | 90502 | Torrance | California |
| Rocky Mountain Cancer Centers | 80120-4413 | Littleton | Colorado |
| Georgetown University Medical Center | 20007 | Washington | District of Columbia |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.