A Study to Learn About the Study Medicine PF-07220060 Together With Letrozole Compared to Letrozole Alone in Women Post Menopause
NCT ID: NCT06465368
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2024-07-11
2025-07-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A/Experimental/PF-07220060 plus letrozole
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.
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
Arm B/Control/letrozole
Letrozole given by mouth once a day for 14 days.
letrozole
Letrozole given as tablet by mouth once a day for 14 days
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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 City, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2024-512848-30-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4391025
Identifier Type: -
Identifier Source: org_study_id
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