The purpose of this study is to learn about the effects of the study medicine PF-07220060 plus letrozole, compared with the effects of taking letrozole alone without PF-07220060 for treatment of breast cancer. This study is seeking for participants who are: * women of age 18 years and older post menopause (either naturally or surgically). * confirmed to have Hormone receptor (HR) positive, Human epidermal growth factor receptor 2 (HER2) negative breast cancer. HER2 negative describes cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2 negative may grow more slowly and are less likely to recur (come back) or spread to other parts of the body than cancer cells that have a large amount of HER2 on their surface. * not been treated for their cancer before this study. Participants will be randomly assigned (like flipping a coin) to receive the treatment (PF-07220060 plus letrozole) or letrozole alone. Both PF-07220060 and letrozole are taken by mouth. PF-07220060 will be taken twice a day for 14 days. Letrozole will be taken once a day for 14 days. Participants will have a screening period for up to 28 days. If deemed fit, they will receive study treatment for 14 days, and then will have a follow-up visit about 28 days after their last dose. All participants will have at least one biopsy during the study. Biopsy is the removal of cells or tissues for examining. All participants will have a biopsy on Day 14. Additional assessments for safety including blood draws and interviews done by the site staff will be completed during the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
121
PF-07220060 given as tablet by mouth twice a day for 14 days.
Letrozole given as tablet by mouth once a day for 14 days
Advocate Good Shepherd Hospital
Barrington, Illinois, United States
AMG -Crystal Lake
Crystal Lake, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Advocate Medical Group
Park Ridge, Illinois, United States
Baylor College of Medicine Medical Center
Houston, Texas, United States
Rate of Ki-67
Centrally assessed biopsy
Time frame: Day 14
Incidence of Adverse Events (AEs)
Time frame: Baseline, Day 14, and Day 28 post last treatment follow-up visit
Incidence of Serious AEs
Time frame: Baseline, Day 14, and Day 28 post last treatment follow-up visit
Incidence of AEs leading to Discontinuation
Time frame: Baseline, Day 14, and Day 28 post last treatment follow-up visit
Ctrough and peri-biopsy plasma concentrations of PF-07220060
Ctrough was defined as pre-dose serum concentration during multiple dosing and observed directly from data.
Time frame: Pre-dose within 30 minutes and post-dose within 1 hour before or after biopsy
Circulating tumor DNA (ctDNA) measurements
Evaluate response on treatment
Time frame: Baseline and Day 14
Percentage of Ki-67
All participants will have Ki-67 staining from the biopsy sample on Day 14 and Screening if not previously available
Time frame: Screening and Day 14
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Baylor St. Luke's Medical Center
Houston, Texas, United States
Ben Taub General Hospital
Houston, Texas, United States
Harris Health System - Smith Clinic
Houston, Texas, United States
O'Quinn Medical Tower - McNair Campus
Houston, Texas, United States
START San Antonio
San Antonio, Texas, United States
...and 41 more locations