What is the Purpose of this Study?
This study focuses on people who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer and have not received any systemic anti-cancer treatment for their disease. The study will explore the effects of an experimental drug called PF-07220060 plus another drug, letrozole, and whether it is more effective compared to currently approved drugs (palbociclib, abemaciclib, or ribociclib) in combination with letrozole. Participants will be randomly assigned to receive either PF-07220060 plus letrozole or any of the comparative (standard-of-care) drugs plus letrozole, based on the study doctor’s decision. PF-07220060 and comparative drugs work by blocking specific growth signals within breast cancer cells, which prevents the cells from doubling its DNA and dividing.
Eligibility
- * Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
- * Documented estrogen receptor (ER) and/or progesterone receptor (PR)-positive tumor
- * Documented HER2-negative tumor
- * Previously untreated with any systemic anticancer therapy for their locally advanced or metastatic disease.
Where can I participate?
- CS Cancer at Beverly Hills : Nikki Kem-Bernard
- CS Cancer at Cedars-Sinai Medical Center : Nikki Kem-Bernard
- Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer
More about this Clinical Trial
What is the full name of this clinical trial?
C4391024: An Interventional, Open-Label, Randomized, Multicenter Phase 3 Study Of PF-07220060 Plus LETROZOLE Compared To CDK4/6 Inhibitor Plus LETROZOLE In Participants Over 18 Years Of Age With Hormone Receptor -Positive, HER2-Negative Advanced/Metastatic Breast Cancer Who Have Not Received Any Prior Systemic Anticancer Treatment For Advanced/Metastatic Disease