Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-01-27 @ 12:29 PM
Study NCT ID:
NCT06465368
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2024-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Learn About the Study Medicine PF-07220060 Together With Letrozole Compared to Letrozole Alone in Women Post Menopause
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2024-06-13', 'studyFirstSubmitQcDate': '2024-06-13', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Ki-67', 'timeFrame': 'Day 14', 'description': 'Centrally assessed biopsy'}], 'secondaryOutcomes': [{'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'Baseline, Day 14, and Day 28 post last treatment follow-up visit'}, {'measure': 'Incidence of Serious AEs', 'timeFrame': 'Baseline, Day 14, and Day 28 post last treatment follow-up visit'}, {'measure': 'Incidence of AEs leading to Discontinuation', 'timeFrame': 'Baseline, Day 14, and Day 28 post last treatment follow-up visit'}, {'measure': 'Ctrough and peri-biopsy plasma concentrations of PF-07220060', 'timeFrame': 'Pre-dose within 30 minutes and post-dose within 1 hour before or after biopsy', 'description': 'Ctrough was defined as pre-dose serum concentration during multiple dosing and observed directly from data.'}, {'measure': 'Circulating tumor DNA (ctDNA) measurements', 'timeFrame': 'Baseline and Day 14', 'description': 'Evaluate response on treatment'}, {'measure': 'Percentage of Ki-67', 'timeFrame': 'Screening and Day 14', 'description': 'All participants will have Ki-67 staining from the biopsy sample on Day 14 and Screening if not previously available'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['human epidermal growth factor receptor 2 (HER2)', 'hormone receptor (HR)', 'HER2-negative', 'HR-Positive', 'Breast Cancer (BC)', 'Neoadjuvant', 'Postmenopausal'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C4391025', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis study is seeking for participants who are:\n\n* women of age 18 years and older post menopause (either naturally or surgically).\n* 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.\n* not been treated for their cancer before this study.\n\nParticipants 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.\n\nParticipants 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.\n\nAll 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.\n\nAdditional assessments for safety including blood draws and interviews done by the site staff will be completed during the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women with histologically confirmed HR-positive and HER2-negative BC (per local assessment)\n* Documented by estrogen receptor (ER) and/or progesterone receptor (PR)-positive disease by IHC or ISH\n* Participants must have Ki-67 score \\>/=10% with unilateral, invasive T1c-T4c, N0-N2, M0 BC\n* Participants must be willing and able to undergo a baseline and Day 14 biopsy and must have an ECOG PS or 0 or 1.\n* 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.\n\nExclusion Criteria:\n\n* No prior systemic therapy, radiation, surgery, investigational therapy for treatment of breast cancer\n* 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\n* Lab abnormalities outside protocol specified parameters'}, 'identificationModule': {'nctId': 'NCT06465368', 'briefTitle': 'A Study to Learn About the Study Medicine PF-07220060 Together With Letrozole Compared to Letrozole Alone in Women Post Menopause', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'C4391025'}, 'secondaryIdInfos': [{'id': '2024-512848-30-00', 'type': 'REGISTRY', 'domain': 'CTIS (EU)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A/Experimental/PF-07220060 plus letrozole', 'description': '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.', 'interventionNames': ['Drug: PF-07220060', 'Drug: letrozole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B/Control/letrozole', 'description': 'Letrozole given by mouth once a day for 14 days.', 'interventionNames': ['Drug: letrozole']}], 'interventions': [{'name': 'PF-07220060', 'type': 'DRUG', 'description': 'PF-07220060 given as tablet by mouth twice a day for 14 days.', 'armGroupLabels': ['Arm A/Experimental/PF-07220060 plus letrozole']}, {'name': 'letrozole', 'type': 'DRUG', 'otherNames': ['Femara'], 'description': 'Letrozole given as tablet by mouth once a day for 14 days', 'armGroupLabels': ['Arm A/Experimental/PF-07220060 plus letrozole', 'Arm B/Control/letrozole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60010', 'city': 'Barrington', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Good Shepherd Hospital', 'geoPoint': {'lat': 42.15391, 'lon': -88.13619}}, {'zip': '60014', 'city': 'Crystal Lake', 'state': 'Illinois', 'country': 'United States', 'facility': 'AMG -Crystal Lake', 'geoPoint': {'lat': 42.24113, 'lon': -88.3162}}, {'zip': '60068', 'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Lutheran General Hospital', 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'zip': '60068', 'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Medical Group', 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Baylor St. Luke's Medical Center", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Ben Taub General Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Harris Health System - Smith Clinic', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "O'Quinn Medical Tower - McNair Campus", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'START San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '3000', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Royal Melbourne Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '1070', 'city': 'Anderlecht', 'state': 'Bruxelles-capitale, Région de', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.83619, 'lon': 4.31454}}, {'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-brabant', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '35042', 'city': 'Rennes', 'state': 'Ille-et-vilaine', 'country': 'France', 'facility': 'Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '34070', 'city': 'Montpellier', 'state': 'Languedoc-roussillon', 'country': 'France', 'facility': 'Centre de Cancérologie du Grand Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44805', 'city': 'Saint-Herblain', 'state': 'Loire-atlantique', 'country': 'France', 'facility': "Institut de Cancérologie de l'Ouest", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '42271', 'city': 'Saint Priest En Jarez', 'state': 'Pays de la Loire Region', 'country': 'France', 'facility': 'CHU de Saint-Etienne'}, {'zip': '69310', 'city': 'Pierre-Bénite', 'state': 'Rhône', 'country': 'France', 'facility': 'Centre Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '69230', 'city': 'Saint-Genis-Laval', 'state': 'Rhône', 'country': 'France', 'facility': 'HCL, Centre Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.69542, 'lon': 4.79316}}, {'zip': '94800', 'city': 'Villejuif', 'state': 'Val-de-marne', 'country': 'France', 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '66113', 'city': 'Saarbrücken', 'state': 'Saarland', 'country': 'Germany', 'facility': 'CaritasKlinikum Saarbrücken St. Theresia', 'geoPoint': {'lat': 49.23262, 'lon': 7.00982}}, {'zip': '47014', 'city': 'Meldola', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'zip': '20900', 'city': 'Monza', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Fondazione IRCCS San Gerardo dei Tintori', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '57124', 'city': 'Livorno', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno', 'geoPoint': {'lat': 43.54427, 'lon': 10.32615}}, {'zip': '72100', 'city': 'Brindisi', 'country': 'Italy', 'facility': 'Ospedale Antonio Perrino', 'geoPoint': {'lat': 40.63215, 'lon': 17.93607}}, {'zip': '28100', 'city': 'Novara', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Maggiore della Carità', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'zip': '60-185', 'city': 'Skórzewo', 'state': 'Greater Poland Voivodeship', 'country': 'Poland', 'facility': 'AIDPORT Sp. z o.o.', 'geoPoint': {'lat': 52.39085, 'lon': 16.78934}}, {'zip': '30-727', 'city': 'Krakow', 'state': 'Lesser Poland Voivodeship', 'country': 'Poland', 'facility': 'Pratia MCM Krakow', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '02-781', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '37-700', 'city': 'Przemyśl', 'state': 'Podkarpackie Voivodeship', 'country': 'Poland', 'facility': 'Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu', 'geoPoint': {'lat': 49.78498, 'lon': 22.76728}}, {'zip': '945 05', 'city': 'Komárno', 'state': 'Nitra Region', 'country': 'Slovakia', 'facility': 'Nemocnica AGEL Komarno', 'geoPoint': {'lat': 48.11667, 'lon': 18.31667}}, {'zip': '833 10', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Narodny onkologicky ustav', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '03080', 'city': 'Seoul', 'state': 'Seoul-teukbyeolsi [seoul]', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03203', 'city': 'Elche', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General Universitario de Elche', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona [barcelona]', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'state': 'Catalunya [cataluña]', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '11407', 'city': 'Jerez de la Frontera', 'state': 'Cádiz', 'country': 'Spain', 'facility': 'Hospital Jerez de la Frontera', 'geoPoint': {'lat': 36.68645, 'lon': -6.13606}}, {'zip': '28009', 'city': 'Madrid', 'state': 'Madrid, Comunidad de', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marañon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'state': 'Madrid, Comunidad de', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '30120', 'city': 'El Palmar', 'state': 'Murcia, Región de', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario Virgen de la Arrixaca', 'geoPoint': {'lat': 39.31305, 'lon': -0.3174}}, {'zip': '29010', 'city': 'Málaga', 'state': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '18016', 'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Universitario San Cecilio', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario HM Sanchinarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '80187', 'city': 'Gävle', 'state': 'Gävleborgs LÄN [se-21]', 'country': 'Sweden', 'facility': 'Sjukhuset I Gävle', 'geoPoint': {'lat': 60.67452, 'lon': 17.14174}}, {'zip': '751 85', 'city': 'Uppsala', 'state': 'Uppsala LÄN [se-03]', 'country': 'Sweden', 'facility': 'Akademiska sjukhuset', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'zip': '5000', 'city': 'Aarau', 'state': 'Canton of Aargau', 'country': 'Switzerland', 'facility': 'Tumor Zentrum Aarau', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '5404', 'city': 'Baden', 'country': 'Switzerland', 'facility': 'Kantonsspital Baden', 'geoPoint': {'lat': 47.47333, 'lon': 8.30592}}, {'zip': '704', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '10449', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Mackay Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}