What is the Purpose of this Study?
Primary Objective: To compare the efficacy of PF07220060 in combination with letrozole (Arm A) versus CDK4/6i (investigator s choice: abemaciclib, palbociclib, or ribociclib) in combination with letrozole (Arm B) with respect to progression-free survival (PFS). Secondary Objectives: To compare Arm A versus Arm B with respect to measures of tumor control and to evaluate duration of response within each treatment arm. To compare safety and tolerability between Arm A and Arm B To evaluate patient-reported outcomes (PRO) of health-related quality of life, disease treatment related symptoms, and general health status for each treatment arm To evaluate the relationship between circulating tumor DNA (ctDNA) levels and clinical outcome
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