Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT06760637
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to determine the safety and efficacy of PF-07220060 with letrozole compared to approved treatments (ie, palbociclib, ribociclib or abemaciclib with letrozole) in people with breast cancer:
* HR-positive (breast cancer cells that need estrogen or progesterone to grow)
* HER2-negative (cells that have a small amount or none of a protein called HER2 on their surface);
* locally advanced (that has spread from where it started to nearby tissue or lymph nodes) or metastatic disease (the spread of cancer to other places in the body)
* who have not received any prior systemic anti-cancer treatment for advanced/metastatic disease.
Approximately half of the participants will receive PF-07220060 plus letrozole while the other half of participants will receive the investigator's choice of treatment plus letrozole.
The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1020
- Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
- Documented estrogen receptor (ER) and/or progesterone receptor (PR)-positive tumor
- Documented HER2-negative tumor
- Previously untreated with any systemic anticancer therapy for their locally advanced or metastatic disease.
- Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1
- In visceral crisis at risk of immediately life-threatening complications in the short term.
- Current or past history of central nervous system metastases.
- Have received prior (neo)adjuvant endocrine therapy (ET) and had recurrence during or within 12 months after the last dose of ET.
- Have received prior (neo)adjuvant CDK4/6i and had recurrence during or within 12 months after the last dose of CDK4/6i.
- Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A letrozole PF-07220060 tablet taken by mouth plus Letrozole tablet taken by mouth Arm B letrozole Investigator's Choice of CDK4/6 inhibitor (tablet/capsule) taken by mouth with letrozole tablet taken by mouth Arm B abemaciclib Investigator's Choice of CDK4/6 inhibitor (tablet/capsule) taken by mouth with letrozole tablet taken by mouth Arm B palbociclib Investigator's Choice of CDK4/6 inhibitor (tablet/capsule) taken by mouth with letrozole tablet taken by mouth Arm B ribociclib Investigator's Choice of CDK4/6 inhibitor (tablet/capsule) taken by mouth with letrozole tablet taken by mouth Arm A PF-07220060 PF-07220060 tablet taken by mouth plus Letrozole tablet taken by mouth
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) by BICR From the date of randomization until disease progression or death due to any cause (up to approximately 4 years) Time from the date of randomization to the date of the first documentation of objective progressive disease as determined by blinded independent central review (BICR) per RECIST v1.1, or death due to any cause, whichever occurs first
- Secondary Outcome Measures
Name Time Method Estimated mean change from baseline in EORTC Breast Cancer Module (BR42) Baseline to end of treatment (up to approximately 4 years) Mean change from baseline of ctDNA Baseline to end of treatment (up to approximately 4 years) Overall Survival (OS) From the date of randomization until death due to any cause (up to approximately 13 years). Time from the date of randomization to the date of death due to any cause
Progression Free Survival (PFS) by Investigator From the date of randomization until disease progression or death due to any cause (up to approximately 4 years) Time from the date of randomization to the date of the first documentation of objective progressive disease as determined by investigator per RECIST v1.1, or death due to any cause, whichever occurs first
OR by BICR and by investigator From randomization to progression or death whichever occurs first (up to approximately 4 years) Time from randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression OR death whichever occurs first
Duration of Response (DoR) by BICR and by investigator From the date of CR or PR until objective progressive disease, or death (up to approximately 4 years) Time from the date of CR or PR to the first documentation of objective progressive disease, or death due to any cause, whichever occurs first
Incidence of treatment emergent treatment relatedadverse events (AE) Duration of the study approximately up to 13 years. Incidence and severity of AEs graded according to the NCI CTCAE v5.0
Incidence of treatment emergent treatment relatedserious adverse events Duration of the study approximately up to 13 years. Incidence and severity of AEs graded according to NCI CTCAE v5.0
Estimated mean change from baseline in EORTC QLQ C30 Baseline to end of treatment (up to approximately 4 years) Estimated mean change from baseline in BPI-SF Baseline to end of treatment (up to approximately 4 years) Estimated mean change from baseline in EQ-5D-5L Baseline to end of treatment (up to approximately 4 years)
Related Research Topics
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Trial Locations
- Locations (152)
Complex Oncology Center - Shumen
🇧🇬Shumen, Bulgaria
Ironwood Cancer & Research Centers
🇺🇸Scottsdale, Arizona, United States
Highlands Oncology
🇺🇸Rogers, Arkansas, United States
Highlands Oncology Group
🇺🇸Springdale, Arkansas, United States
Cancer and Blood Research Center, LLC
🇺🇸Los Alamitos, California, United States
Cancer and Blood Specialty Clinic / Cancer and Blood Research Center, LLC
🇺🇸Los Alamitos, California, United States
Cancer AND Blood Specialty Clinic
🇺🇸Torrance, California, United States
Intermountain Health Lutheran Hospital
🇺🇸Golden, Colorado, United States
Lutheran Hospital - Cancer Centers of Colorado
🇺🇸Golden, Colorado, United States
Cancer Centers of Colorado St. Mary's Regional Hospital
🇺🇸Grand Junction, Colorado, United States
Intermountain Health Saint Mary's Regional Hospital
🇺🇸Grand Junction, Colorado, United States
Intermountain Health
🇺🇸Grand Junction, Colorado, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
AdventHealth Altamonte Infusion Center
🇺🇸Altamonte Springs, Florida, United States
AdventHealth Altamonte Springs
🇺🇸Altamonte Springs, Florida, United States
AdventHealth Medical Group Altamonte
🇺🇸Altamonte Springs, Florida, United States
Mount Sinai Medical Center, Aventura
🇺🇸Aventura, Florida, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Mid Florida Hematology and Oncology Center
🇺🇸Orange City, Florida, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
AdventHealth Medical Group Orlando
🇺🇸Orlando, Florida, United States
AdventHealth Orlando Infusion Center
🇺🇸Orlando, Florida, United States
Summit Cancer Care, PC
🇺🇸Savannah, Georgia, United States
Endeavor Health
🇺🇸Naperville, Illinois, United States
Ascension Illinois - Evanston Infusion Center
🇺🇸Evanston, Illinois, United States
Ascension Illinois-Skokie Infusion Center
🇺🇸Skokie, Illinois, United States
Orchard Healthcare Research Inc.
🇺🇸Skokie, Illinois, United States
Velocity Clinical Research
🇺🇸Annapolis, Maryland, United States
Mercy Medical Center - Baltimore
🇺🇸Baltimore, Maryland, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute - Chestnut Hill
🇺🇸Newton, Massachusetts, United States
Allina Health Cancer Institute - Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Allina Health Cancer Institute - Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Allina Health Cancer Institute - United Hospital
🇺🇸Saint Paul, Minnesota, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Bozeman Health Deaconess Hospital
🇺🇸Bozeman, Montana, United States
Renown Health
🇺🇸Reno, Nevada, United States
Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
Providence Cancer Institute Franz Clinic
🇺🇸Portland, Oregon, United States
Providence Portland Medical Center Investigational Drug Services
🇺🇸Portland, Oregon, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Providence Investigational Drug Service - Westside
🇺🇸Portland, Oregon, United States
Providence Oncology and Hematology Care Clinic - Westside
🇺🇸Portland, Oregon, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center
🇺🇸Tyler, Texas, United States
The University of Texas Health Science Center at Tyler on behalf of UT Health East Texas HOPE Cancer
🇺🇸Tyler, Texas, United States
Townsville University Hospital
🇦🇺Douglas, Queensland, Australia
Rosebud Hospital
🇦🇺Capel Sound, Victoria, Australia
Frankston Hospital
🇦🇺Frankston, Victoria, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Multiprofile Hospital for Active Treatment Serdika EOOD
🇧🇬Sofia, Sofia (stolitsa), Bulgaria
Complex Oncology Center - Burgas
🇧🇬Burgas, Bulgaria
Multiprofile Hospital for Active Treatment Dr. Tota Venkova AD
🇧🇬Gabrovo, Bulgaria
Specialized Hospital for Active Treatment of Oncology - Haskovo
🇧🇬Haskovo, Bulgaria
Complex Oncology Center - Plovdiv EOOD
🇧🇬Plovdiv, Bulgaria
Dr. Everett Chalmers Regional Hospital
🇨🇦Fredericton, New Brunswick, Canada
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Cancer Hospital Chinese Academy of Medical Science
🇨🇳Beijing, Beijing, China
Beijing Cancer hospital
🇨🇳Beijing, Beijing, China
The First People's Hospital of Foshan
🇨🇳Foshan, Guangdong, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The 2nd Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China
Sir Run Run Shaw Hospital
🇨🇳Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
🇨🇳Linhai, Zhejiang, China
Fakultni nemocnice v Motole
🇨🇿Praha, Praha 5, Czechia
Rigshospitalet
🇩🇰Copenhagen, Hovedstaden, Denmark
Aarhus Universitetshospital, Skejby
🇩🇰Aarhus, Midtjylland, Denmark
Tampereen yliopistollinen sairaala
🇫🇮Tampere, Pirkanmaa, Finland
Vaasan Keskussairaala
🇫🇮Vaasa, Pohjanmaa, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
🇫🇮Helsinki, Uusimaa, Finland
Turku University Hospital
🇫🇮Turku, Varsinais-suomi, Finland
CHD Vendee
🇫🇷La Roche-sur-Yon, Vendée, France
InVO Institut für Versorgungsforschung in der Onkologie
🇩🇪Koblenz, Rheinland-pfalz, Germany
Hygeia Hospital
🇬🇷Marousi, Attikí, Greece
Rajiv Gandhi Cancer Institute And Research Centre
🇮🇳New Delhi, Delhi, India
Nirmal Hospital Pvt Ltd.
🇮🇳Surat, Gujarat, India
Artemis hospital
🇮🇳Gurugram, Haryana, India
Spandana Oncology Centre (SOC)
🇮🇳Bangalore, Karnataka, India
Tata Memorial Hospital
🇮🇳Mumbai, Maharashtra, India
Apex Wellness Hospital
🇮🇳Nashik, Maharashtra, India
Sahyadri Super Speciality Hospital
🇮🇳Pune, Maharashtra, India
Bhakti Vedanta Hospital and Research Institute
🇮🇳Thane, Maharashtra, India
Basavatarakam Indo American Cancer Hospital & Research Institute
🇮🇳Hyderabad, Telangana, India
Apollo Multispeciality Hospitals limited
🇮🇳Kolkata, WEST Bengal, India
Rabin Medical Center
🇮🇱Petah Tikva, Hamerkaz, Israel
Sheba Medical Center
🇮🇱Ramat Gan, Hamerkaz, Israel
Rambam Health Care Campus
🇮🇱Haifa, Hatsafon, Israel
Sourasky Medical Center
🇮🇱Tel Aviv, Tell Abīb, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Yerushalayim, Israel
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Toscana, Italy
Istituto Europeo di Oncologia IRCCS
🇮🇹Milano, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
🇮🇹Novara, Italy
Nagoya University Hospital
🇯🇵Nagoya, Aichi, Japan
Nagoya City University Hospital
🇯🇵Nagoya, Aichi, Japan
Gunma Prefectural Cancer Center
🇯🇵Otashi, Gunma, Japan
National Hospital Organization Hokkaido Cancer Center
🇯🇵Sapporo, Hokkaido, Japan
Kanagawa cancer center
🇯🇵Yokohama, Kanagawa, Japan
Kyoto University Hospital
🇯🇵Sakyo-ku, Kyoto, Japan
Tohoku University Hospital
🇯🇵Sendai, Miyagi, Japan
Osaka University Hospital
🇯🇵Suita, Osaka, Japan
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
🇯🇵Koto-ku, Tokyo, Japan
Showa University Hospital
🇯🇵Shinagawa, Tokyo, Japan
Center Hospital of the National Center for Global Health and Medicine
🇯🇵Shinjuku-ku, Tokyo, Japan
Chiba Cancer Center
🇯🇵Chiba, Japan
National Hospital Organization Kyushu Cancer Center
🇯🇵Fukuoka, Japan
Hiroshima City Hiroshima Citizens Hospital
🇯🇵Hiroshima, Japan
Kumamoto Shinto General Hospital
🇯🇵Kumamoto, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
National Hospital Organization Osaka National Hospital
🇯🇵Osaka, Japan
Osaka International Cancer Institute
🇯🇵Osaka, Japan
Pratia MCM Krakow
🇵🇱Kraków, Małopolskie, Poland
AIDPORT Sp. z o.o.
🇵🇱Skórzewo, Wielkopolskie, Poland
Instytut MSF Sp zoo
🇵🇱Łódź, Łódzkie, Poland
Nemocnica AGEL Komarno
🇸🇰Komarno, Nitriansky KRAJ, Slovakia
Medeon, s.r.o.
🇸🇰Banka, Trnavský KRAJ, Slovakia
Hospital General Universitario de Elche
🇪🇸Elche, Alicante, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Barcelona [barcelona], Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Málaga, Spain
Hospital Universitario San Cecilio
🇪🇸Granada, Spain
Hospital Universitario HM Sanchinarro
🇪🇸Madrid, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
🇪🇸Salamanca, Spain
Sjukhuset I Gävle
🇸🇪Gävle, Gävleborgs LÄN [se-21], Sweden
Akademiska sjukhuset
🇸🇪Uppsala, Uppsala LÄN [se-03], Sweden
Västmanlands Sjukhus Västerås
🇸🇪Västerås, Västmanlands LÄN [se-19], Sweden
Sahlgrenska Universitetssjukhuset
🇸🇪Gothenburg, Västra Götalands LÄN [se-14], Sweden
Lanssjukhuset Ryhov
🇸🇪Jönköping, Sweden
Sundsvalls Sjukhus
🇸🇪Sundsvall, Sweden
Kantonsspital Graubünden
🇨🇭Chur, Switzerland
Kantonsspital Olten
🇨🇭Olten, Switzerland
National Taiwan University Hospital - Hsinchu branch
🇨🇳Zhu Bei City, Hsinchu, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch
🇨🇳Taoyuan, Taiwan
İ.A.Ü VM Medical Park Florya Hastanesi
🇹🇷Istanbul, İ̇stanbul, Turkey
Memorial Ankara Hastanesi
🇹🇷Ankara, Turkey
Dicle Üniversitesi
🇹🇷Diyarbakir, Turkey
Sarah Cannon Research Institute UK
🇬🇧London, London, CITY OF, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom