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
Launched by PFIZER · Jan 3, 2025
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called PF-07220060, given alongside letrozole, for adults with a specific type of breast cancer known as HR-positive HER2-negative breast cancer. This trial aims to find out how safe and effective this combination is compared to other approved treatments that also include letrozole. Participants in the study will include adults who have locally advanced or metastatic breast cancer, which means the cancer has spread beyond its original location and cannot be removed through surgery or radiation. Importantly, eligible participants have not received any previous treatments for their advanced cancer.
If you join this study, you will be randomly assigned to receive either the new treatment (PF-07220060 with letrozole) or another approved treatment with letrozole. Throughout the trial, the study team will monitor your health during regular check-ups at the clinic to see how well the treatment is working. To be eligible, participants need to have confirmed breast cancer that has spread, and their cancer must test positive for hormone receptors (which help it grow) but negative for HER2 (a specific protein). However, some individuals may not qualify if they have had certain previous treatments or specific health issues.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- Exclusion Criteria:
- • 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.
About Pfizer
Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Madrid, , Spain
Miami Beach, Florida, United States
Portland, Oregon, United States
Malaga, , Spain
Boise, Idaho, United States
Portland, Oregon, United States
Frankston, Victoria, Australia
Boston, Massachusetts, United States
Orlando, Florida, United States
Washington, District Of Columbia, United States
Miami Beach, Florida, United States
Los Angeles, California, United States
Woolloongabba, Queensland, Australia
Kansas City, Missouri, United States
Reno, Nevada, United States
Uppsala, , Sweden
Boca Raton, Florida, United States
Parkville, Victoria, Australia
Taipei, , Taiwan
Mumbai, Maharashtra, India
Barcelona, , Spain
Elche, Alicante, Spain
Sapporo, Hokkaido, Japan
Sendai, Miyagi, Japan
Chuo Ku, Tokyo, Japan
Okayama, , Japan
Nagoya, Aichi, Japan
Taichung, , Taiwan
Tainan, , Taiwan
Sevilla, , Spain
Osaka, , Japan
Suita, Osaka, Japan
Taipei, , Taiwan
Melbourne, Victoria, Australia
Praha, , Czechia
Prague, , Czechia
Sakyo Ku, Kyoto, Japan
Chiba, , Japan
Bunkyo Ku, Tokyo, Japan
Barcelona, , Spain
Bayonne, , France
Manchester, , United Kingdom
Guangzhou, Guangdong, China
Nagoya, Aichi, Japan
Chur, , Switzerland
Olten, , Switzerland
Winterthur, , Switzerland
Changchun, Jilin, China
Nagoya, Aichi, Japan
Taoyuan, , Taiwan
Incheon, , Korea, Republic Of
Beijing, Beijing, China
Shenyang, Liaoning, China
Toronto, Ontario, Canada
Fukuoka, , Japan
Koto Ku, Tokyo, Japan
Pune, Maharashtra, India
Xi'an, Shaanxi, China
Taipei, , Taiwan
Seoul, Songpa Gu, Korea, Republic Of
Baden, , Switzerland
Foshan, Guangdong, China
Milano, , Italy
Pasadena, California, United States
Leuven, Vlaams Brabant, Belgium
Skokie, Illinois, United States
Los Angeles, California, United States
Changsha, Hunan, China
Seoul, , Korea, Republic Of
Hangzhou, Zhejiang, China
Stockholm, , Sweden
Beijing, Beijing, China
Créteil, , France
Chandler, Arizona, United States
Springdale, Arkansas, United States
Granada, , Spain
Savannah, Georgia, United States
West Hills, California, United States
Surat, Gujarat, India
Linhai, Zhejiang, China
Budapest, , Hungary
Yokohama, Kanagawa, Japan
Osaka, , Japan
Hiroshima, , Japan
Kumamoto, , Japan
Tel Aviv, , Israel
Seoul, , Korea, Republic Of
Otwock, , Poland
Taipei, , Taiwan
Bozeman, Montana, United States
Madrid, , Spain
Hamburg, , Germany
Glendale, Arizona, United States
Istanbul, , Turkey
Gothenburg, , Sweden
Jerusalem, Yerushalayim, Israel
Beijing, Beijing, China
Orange City, Florida, United States
Pune, Maharashtra, India
Newport Beach, California, United States
Layton, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Turku, Varsinais Suomi, Finland
Los Angeles, California, United States
Fredericton, New Brunswick, Canada
Burgas, , Bulgaria
Gurugram, Haryana, India
Tyler, Texas, United States
Firenze, Toscana, Italy
Gent, Oost Vlaanderen, Belgium
Plovdiv, , Bulgaria
Portland, Oregon, United States
Portland, Oregon, United States
Ankara, , Turkey
La Roche Sur Yon, , France
Dublin, , Ireland
Orlando, Florida, United States
Rogers, Arkansas, United States
Copenhagen, Hovedstaden, Denmark
Västerås, , Sweden
Newton, Massachusetts, United States
New Delhi, Delhi, India
Reno, Nevada, United States
Salamanca, , Spain
Aarhus, Midtjylland, Denmark
Shinjuku Ku, Tokyo, Japan
West Valley City, Utah, United States
Bordeaux, Aquitaine, France
Sofia, , Bulgaria
Shinagawa, Tokyo, Japan
Dublin, , Ireland
Nashik, Maharashtra, India
Douglas, Queensland, Australia
Novara, , Italy
Gilly, Hainaut, Belgium
Fayetteville, Arkansas, United States
Aalborg, Nordjylland, Denmark
Tampere, Pirkanmaa, Finland
Thane, Maharashtra, India
Uppsala, , Sweden
Bountiful, Utah, United States
Ogden, Utah, United States
Provo, Utah, United States
Rouen, Seine Maritime, France
Vaasa, Pohjanmaa, Finland
Angers Cedex 02, Maine Et Loire, France
Haifa, Hatsafon, Israel
Ramat Gan, Hamerkaz, Israel
Shinjuku City, Tokyo, Japan
Montpellier, Languedoc Roussillon, France
Aviano, Friuli Venezia Giulia, Italy
Barcelona, Barcelona [Barcelona], Spain
Diyarbakir, , Turkey
Istanbul, , Turkey
Wuhan, Hubei, China
Ankara, , Turkey
La Roche Sur Yon, Vendée, France
Petah Tikva, Hamerkaz, Israel
Tel Aviv, Tell Abīb, Israel
Saint Herblain, Loire Atlantique, France
Koblenz, Rheinland Pfalz, Germany
Helsinki, Uusimaa, Finland
Dresden, Sachsen, Germany
Gävle, , Sweden
Malaga, Málaga, Spain
Altamonte Springs, Florida, United States
Praha, Praha 5, Czechia
Rome, Roma, Italy
Kraków, , Poland
Haskovo, , Bulgaria
Ankara, , Turkey
Phoenix, Arizona, United States
Hinsdale, Illinois, United States
Shumen, , Bulgaria
Meldola, Emilia Romagna, Italy
Aarau, Aargau, Switzerland
Frauenfeld, Thurgau, Switzerland
Los Angeles, California, United States
Minneapolis, Minnesota, United States
Jerez De La Frontera, , Spain
Gabrovo, , Bulgaria
Sofia, , Bulgaria
Gothenburg, , Sweden
Otashi, Gunma, Japan
Västerås, , Sweden
Bern, Berne, Switzerland
Ankara, , Turkey
Dalian, Liaoning, China
Kolkata, West Bengal, India
Nanjing, Jiangsu, China
Kraków, Małopolskie, Poland
Evanston, Illinois, United States
Skokie, Illinois, United States
Soenderborg, Syddanmark, Denmark
Sofia, Sofia (Stolitsa), Bulgaria
Istanbul, , Turkey
Eger, Heves, Hungary
London, London, City Of, United Kingdom
Naperville, Illinois, United States
London, Hammersmith And Fulham, United Kingdom
Marousi, , Greece
Golden, Colorado, United States
Rennes, Ille Et Vilaine, France
Gilbert, Arizona, United States
Mesa, Arizona, United States
Scottsdale, Arizona, United States
Bangalore, Karnataka, India
Dresden, , Germany
Skórzewo, Wielkopolskie, Poland
Komarno, Nitriansky Kraj, Slovakia
Banka, Trnavský Kraj, Slovakia
Denver, Colorado, United States
Los Alamitos, California, United States
Baltimore, Maryland, United States
Zhu Bei City, , Taiwan
Aalst, , Belgium
New Lenox, Illinois, United States
Annapolis, Maryland, United States
Esbjerg, Syddanmark, Denmark
Torrance, California, United States
Coon Rapids, Minnesota, United States
Saint Paul, Minnesota, United States
Altamonte Springs, Florida, United States
Altamonte Springs, Florida, United States
Aventura, Florida, United States
Orlando, Florida, United States
Elmhurst, Illinois, United States
Portland, Oregon, United States
Portland, Oregon, United States
Tyler, Texas, United States
Los Alamitos, California, United States
Golden, Colorado, United States
Grand Junction, Colorado, United States
Grand Junction, Colorado, United States
Grand Junction, Colorado, United States
Capel Sound, Victoria, Australia
Marousi, Attikí, Greece
Hyderabad, Telangana, India
łódź, łódzkie, Poland
Jönköping, , Sweden
Sundsvall, , Sweden
Istanbul, İ̇stanbul, Turkey
Kansas City, Missouri, United States
Gangnam Gu, , Korea, Republic Of
Bilbo, , Spain
Athens, , Greece
Kraków, , Poland
Sakarya, , Turkey
London, , United Kingdom
Zhu Bei City, Hsinchu, Taiwan
Banka, , Slovakia
Gävle, , Sweden
Newport Beach, California, United States
Denver, Colorado, United States
Boise, Idaho, United States
Fruitland, Idaho, United States
Meridian, Idaho, United States
Meridian, Idaho, United States
Nampa, Idaho, United States
Murray, Utah, United States
Orem, Utah, United States
Pleasant Grove, Utah, United States
Nový Jičín, , Czechia
αθήνα, , Greece
Athens, , Greece
Dublin, , Ireland
łódź, , Poland
Michalovce, , Slovakia
Hospitalet, , Spain
Stockholm, , Sweden
Münsterlingen, , Switzerland
Patients applied
Trial Officials
Pfizer CT.gov Call Center
Study Director
Pfizer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported