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

NCT06465368 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: C43910252024-512848-30-00
• Study Type: interventional
• Target: 121
• Locations: 13 countries
• Sites: 51

Brief 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.

Conditions

Breast Cancer

Keywords

human epidermal growth factor receptor 2 (HER2); hormone receptor (HR); HER2-negative; HR-Positive; Breast Cancer (BC); Neoadjuvant; Postmenopausal

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Complete Cell Cycle Arrest (CCCA) at Day 14

  CCCA was determined by antigen Kiel 67 (Ki-67) value as decided by Sponsor. Ki-67 was extensively used as a prognostic and predictive biomarker for cancer diagnosis and treatment. Ki-67 expression was measured by immunohistochemistry. Assessment at Day 14 was done in blinded manner by centrally assessed biopsy.

  Day 14

Secondary Outcomes (8)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  From start of study intervention (Day 1) up to 35 days after the last dose of study intervention or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first (approximately up to 49 days)

• Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)

  From start of study intervention (Day 1) up to 35 days after the last dose of study intervention or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first (approximately up to 49 days)

• Number of Participant With AEs Leading to Any Study Intervention Discontinuation

  During study treatment (maximum up to 14 days)

• Circulating Tumor Deoxyribonucleic Acid (ctDNA) Methylation Tumor Fraction Values at Baseline and Day 14

  Baseline (the last measurement on or prior to date of the first dose of study intervention if the first dose is not missing, otherwise, on or prior to the randomization date), Day 14 (pre-dose)

• Plasma Concentration (Ctrough) of PF-07220060 on Day 14

  Pre-dose (within 30 minutes before dosing) on Day 14

Study Arms (2)

Arm A/Experimental/PF-07220060 plus letrozole

EXPERIMENTAL

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.

Drug: PF-07220060; Drug: letrozole

Arm B/Control/letrozole

ACTIVE COMPARATOR

Letrozole given by mouth once a day for 14 days.

Drug: letrozole

Interventions

PF-07220060 DRUG

PF-07220060 given as tablet by mouth twice a day for 14 days.

Arm A/Experimental/PF-07220060 plus letrozole

letrozole DRUG

Letrozole given as tablet by mouth once a day for 14 days

Also known as: Femara

Arm A/Experimental/PF-07220060 plus letrozole; Arm B/Control/letrozole

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (51)

Advocate Good Shepherd Hospital

Barrington, Illinois, 60010, United States

Location

AMG -Crystal Lake

Crystal Lake, Illinois, 60014, United States

Location

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

Advocate Medical Group

Park Ridge, Illinois, 60068, United States

Location

Baylor College of Medicine Medical Center

Houston, Texas, 77030, United States

Location

Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

Harris Health System - Smith Clinic

Houston, Texas, 77054, United States

Location

O'Quinn Medical Tower - McNair Campus

Houston, Texas, 77054, United States

Location

START San Antonio

San Antonio, Texas, 78229, United States

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3052, Australia

Location

Institut Jules Bordet

Anderlecht, Bruxelles-capitale, Région de, 1070, Belgium

Location

UZ Leuven

Leuven, Vlaams-brabant, 3000, Belgium

Location

Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer

Rennes, Ille-et-vilaine, 35042, France

Location

Centre de Cancérologie du Grand Montpellier

Montpellier, Languedoc-roussillon, 34070, France

Location

Institut de Cancérologie de l'Ouest

Saint-Herblain, Loire-atlantique, 44805, France

Location

CHU de Saint-Etienne

Saint Priest En Jarez, Pays de la Loire Region, 42271, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, Rhône, 69310, France

Location

HCL, Centre Hospitalier Lyon Sud

Saint-Genis-Laval, Rhône, 69230, France

Location

Gustave Roussy

Villejuif, Val-de-marne, 94800, France

Location

CaritasKlinikum Saarbrücken St. Theresia

Saarbrücken, Saarland, 66113, Germany

Location

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

Meldola, Emilia-Romagna, 47014, Italy

Location

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lombardy, 20900, Italy

Location

Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno

Livorno, Tuscany, 57124, Italy

Location

Ospedale Antonio Perrino

Brindisi, 72100, Italy

Location

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, 28100, Italy

Location

AIDPORT Sp. z o.o.

Skórzewo, Greater Poland Voivodeship, 60-185, Poland

Location

Pratia MCM Krakow

Krakow, Lesser Poland Voivodeship, 30-727, Poland

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu

Przemyśl, Podkarpackie Voivodeship, 37-700, Poland

Location

Nemocnica AGEL Komarno

Komárno, Nitra Region, 945 05, Slovakia

Location

Narodny onkologicky ustav

Bratislava, 833 10, Slovakia

Location

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [seoul], 03080, South Korea

Location

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [barcelona], 08035, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalunya [cataluña], 08041, Spain

Location

Hospital Jerez de la Frontera

Jerez de la Frontera, Cádiz, 11407, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Comunidad de, 28009, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, 28041, Spain

Location

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Región de, 30120, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, 29010, Spain

Location

Hospital Universitario San Cecilio

Granada, 18016, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

Sjukhuset I Gävle

Gävle, Gävleborgs LÄN [se-21], 80187, Sweden

Location

Akademiska sjukhuset

Uppsala, Uppsala LÄN [se-03], 751 85, Sweden

Location

Tumor Zentrum Aarau

Aarau, Canton of Aargau, 5000, Switzerland

Location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Kantonsspital Baden

Baden, 5404, Switzerland

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov.Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: July 11, 2024
• Primary Completion: July 10, 2025
• Study Completion: July 10, 2025
• Last Updated: July 15, 2026
• Results First Posted: July 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

CH (3); TW (2); BE (2); US (10); ES (10); PL (4); AU (2); FR (7); IT (5); SE (2); DE (1); SL (2); KR (1)