A Study to Learn About the Study Medicine PF-07220060 Together With Letrozole Compared to Letrozole Alone in Women Post Menopause

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT06465368

Run by

Pfizer

People needed

121

Starts

2024-07-11

Expected to finish

2025-07-10

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Postmenopausal women with histologically confirmed HR-positive and HER2-negative BC (per local assessment)
• Documented by estrogen receptor (ER) and/or progesterone receptor (PR)-positive disease by IHC or ISH
• Participants must have Ki-67 score >/=10% with unilateral, invasive T1c-T4c, N0-N2, M0 BC
• Participants must be willing and able to undergo a baseline and Day 14 biopsy and must have an ECOG PS or 0 or 1.
• Participants must be treatment naive for the treatment of BC and cannot have had prior treatment with any systemic therapy (e.g., chemotherapy, hormonal therapy), radiation, surgery, or any investigational agents or use of hormone replacement therapy (HRT) or any other estrogen-containing medication (including vaginal estrogen) within 2 weeks prior to diagnostic tissue sample taken.

You may not qualify if…

• No prior systemic therapy, radiation, surgery, investigational therapy for treatment of breast cancer
• Certain medical conditions in the previous 6 months, for example: myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism or other clinically significant episode of thromboembolism
• Lab abnormalities outside protocol specified parameters

Where it is running

• 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
• 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
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
• Royal Melbourne Hospital — Parkville, Victoria, Australia
• Institut Jules Bordet — Anderlecht, Bruxelles-capitale, Région de, Belgium
• UZ Leuven — Leuven, Vlaams-brabant, Belgium
• Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer — Rennes, Ille-et-vilaine, France
• Centre de Cancérologie du Grand Montpellier — Montpellier, Languedoc-roussillon, France
• Institut de Cancérologie de l'Ouest — Saint-Herblain, Loire-atlantique, France
• CHU de Saint-Etienne — Saint Priest En Jarez, Pays de la Loire Region, France
• Centre Hospitalier Lyon Sud — Pierre-Bénite, Rhône, France
• HCL, Centre Hospitalier Lyon Sud — Saint-Genis-Laval, Rhône, France
• Gustave Roussy — Villejuif, Val-de-marne, France
• CaritasKlinikum Saarbrücken St. Theresia — Saarbrücken, Saarland, Germany
• IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" — Meldola, Emilia-Romagna, Italy
• Fondazione IRCCS San Gerardo dei Tintori — Monza, Lombardy, Italy
• Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno — Livorno, Tuscany, Italy
• Advocate Good Shepherd Hospital — Barrington, Illinois, United States

Full record on ClinicalTrials.gov

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