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A Study to Learn About the Study Medicine PF-07220060 Together With Letrozole Compared to Letrozole Alone in Women Post Menopause
Sponsor: Pfizer
Summary
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.
Official title: AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE 2 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO LETROZOLE ALONE IN POSTMENOPAUSAL WOMEN 18 YEARS OR OLDER WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE BREAST CANCER IN THE NEOADJUVANT SETTING
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
121
Start Date
2024-07-11
Completion Date
2025-07-10
Last Updated
2026-07-15
Healthy Volunteers
No
Conditions
Interventions
PF-07220060
PF-07220060 given as tablet by mouth twice a day for 14 days.
letrozole
Letrozole given as tablet by mouth once a day for 14 days
Locations (51)
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
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
Ospedale Antonio Perrino
Brindisi, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, Italy
AIDPORT Sp. z o.o.
Skórzewo, Greater Poland Voivodeship, Poland
Pratia MCM Krakow
Krakow, Lesser Poland Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, Masovian Voivodeship, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemyśl, Podkarpackie Voivodeship, Poland
Nemocnica AGEL Komarno
Komárno, Nitra Region, Slovakia
Narodny onkologicky ustav
Bratislava, Slovakia
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [cataluña], Spain
Hospital Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Región de, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, Spain
Hospital Universitario San Cecilio
Granada, Spain
Hospital Universitario HM Sanchinarro
Madrid, Spain
Sjukhuset I Gävle
Gävle, Gävleborgs LÄN [se-21], Sweden
Akademiska sjukhuset
Uppsala, Uppsala LÄN [se-03], Sweden
Tumor Zentrum Aarau
Aarau, Canton of Aargau, Switzerland
University Hospital Basel
Basel, Canton of Basel-City, Switzerland
Kantonsspital Baden
Baden, Switzerland
National Cheng Kung University Hospital
Tainan, Taiwan
Mackay Memorial Hospital
Taipei, Taiwan