Phase 3 Study of Gedatolisib as First-Line Treatment for HR-Positive, HER2-Negative Advanced Breast Cancer
Sponsor: Celcuity Inc
ClinicalTrials ID:NCT06757634
This clinical trial is testing a new treatment combination for patients with advanced breast cancer that is hormone receptor positive and HER2 negative. The study aims to evaluate the effectiveness and safety of adding gedatolisib to standard treatments.
Patient Parameters
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Program Overview
The purpose of this study is to test a new treatment combination for patients with advanced breast cancer that is hormone receptor positive (HR+) and HER2 negative (HER2-). The trial will evaluate if adding the drug gedatolisib to standard treatments like fulvestrant and CDK4/6 inhibitors (palbociclib or ribociclib) can help control the cancer better. Gedatolisib is given through an IV and works by blocking certain proteins that help cancer cells grow. The study will compare this new combination to the standard treatment to see which works better.
Description
This Phase 3 clinical trial is testing a new treatment for patients with advanced breast cancer that is HR+ and HER2-. The study will look at how effective and safe it is to add gedatolisib to standard treatments like fulvestrant and CDK4/6 inhibitors (palbociclib or ribociclib). Gedatolisib is a drug given through an IV that targets proteins involved in cancer cell growth. Patients will be divided into groups based on their cancer's genetic makeup and will receive either the new treatment combination or the standard treatment. The trial will help determine if the new combination can better control the cancer compared to the standard treatment alone.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with advanced or metastatic HR+/HER2- breast cancer.
- Adult women (pre- and post-menopausal) and men can participate. Pre-menopausal women must agree to take an additional hormone treatment.
- Women of childbearing potential must have a negative pregnancy test and use effective birth control during the study and for two years after.
- Cancer must have progressed during or within 12 months after completing hormone therapy.
- Must provide a tumor sample for genetic testing.
- Previous treatments allowed include short-term hormone therapy, chemotherapy, and certain CDK4/6 inhibitors.
- Must have measurable cancer that can be tracked with scans.
- Must be in good overall health with a performance status score of 0 to 2.
- Must have a life expectancy of more than 6 months.
- Must have adequate blood cell counts and organ function.
Exclusion Criteria
- Have another active cancer, except for certain skin cancers.
- Have previously taken drugs that target specific cancer growth pathways (PI3K, Akt, mTOR inhibitors).
- Have received prior systemic treatment for advanced breast cancer.
- Have type 1 diabetes.
- Have untreated or active cancer spread to the brain or spinal fluid.
- Have significant heart problems.
- Have a history of lung or liver inflammation caused by medication.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Providence Medical Foundation | 92835 | Fullerton | California |
| UCLA Hematology Oncology Ventura | 93003 | Los Angeles | California |
| The University of Kansas Cancer Center | 66205 | Westwood | Kansas |
| Mercy Health-Paducah Cancer Center | 42003 | Paducah | Kentucky |
| American Oncology Partners, P.A. | 20817 | Bethesda | Maryland |
| Henry Ford Health System | 48202 | Detroit | Michigan |
| Saint Luke's Cancer Institute | 64111-5965 | Kansas City | Missouri |
| Washington University School of Medicine in Saint Louis | 63110 | St Louis | Missouri |
| SCL Health - Cancer Centers of Montana | 59102 | Billings | Montana |
| Weill Cornell Medical College - NewYork-Presbyterian Hospital | 10065 | New York | New York |
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