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 (HR)-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTICANCER TREATMENT FOR ADVANCED/METASTATIC DISEASE (FOURLIGHT-3
Primary:
To compare the efficacy of PF-07220060 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 PFS.
Secondary:
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 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
LETROZOLE
Palbociclib
PF-07220060
Ribociclib (KISQALI)
- RWJBarnabas Health
- Cooperman Barnabas, Livingston
- Jersey City Medical Center, Jersey City
- Monmouth Medical Center
- Newark Beth Israel Medical Center
- Robert Wood Johnson University Hospital, Somerset
- Rutgers University
Inclusion Criteria: - 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. - Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1 Exclusion Criteria: - In visceral crisis at risk of immediately life-threatening complications in the short term. - Current or past history of central nervous system metastases. - Have received prior (neo)adjuvant endocrine therapy (ET) and had recurrence during or within 12 months after the last dose of ET. - Have received prior (neo)adjuvant CDK4/6i and had recurrence during or within 12 months after the last dose of CDK4/6i. - Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.