A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment

Advanced or Metastatic Breast Cancer Clinical Trial

Official title:

AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATOR'S CHOICE OF THERAPY IN PARTICIPANTS OVER 18 YEARS OF AGE WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR CDK 4/6 INHIBITOR-BASED THERAPY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06105632
• Other study ID #: C4391022
• Secondary ID: 2023-506487-13-0
• Status: Recruiting
• Phase: Phase 3
• Start date: January 9, 2024
• Est. completion date: December 8, 2028

Study information

• Verified date: June 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to learn about the safety and how effective the study medicine (PF-07220060) plus fulvestrant is compared to the study doctor's choice of treatment in people with advanced or metastatic breast cancer. Advanced cancer is the one that is unlikely to be cured or taken care of with treatment. Metastatic cancer is the one that has spread to other parts of the body.

This study is seeking female and male participants who:

• are 18 years of age or older;

• are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative;

• have advanced or metastatic breast cancer after taking other treatments before this study;

• have not taken or need to take medications that are not allowed by the study protocol;

• do not have any medical or mental conditions that may increase the risk of study participation.

Half of the participants will take PF-07220060 two times daily by mouth along with fulvestrant. Fulvestrant will be given as a shot into the muscle. The other half will take the study doctor's choice of treatment which can either be:

• Fulvestrant alone taken as shot into the muscle.

• Everolimus along with exemestane taken once daily by mouth.

This study will compare the experiences of participants receiving the study medicine plus fulvestrant to those who are receiving the study doctor's choice of treatment. This will help decide if the study medicine is safe and effective.

Participants will receive study treatment and/or will be in the study until:

• imaging scans (such as an MRI and/or CT) show that their cancer is getting worse.

• the study doctor thinks the participant is no longer benefitting from the study medicine.

• has side effects that become too severe. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take.

• the participant chooses to stop taking part.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 510
• Est. completion date: December 8, 2028
• Est. primary completion date: December 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• Able to provide a sufficient amount of representative formalin fixed, paraffin embedded (FFPE) tumor tissue specimen.

• Must have received CDK4/6i plus NSAI defined per study protocol. There must be documented PD during or after CDK4/6i treatment.

• Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1.

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) =2.

Exclusion Criteria:

• Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.

• In visceral crisis at risk of immediately life-threatening complications in the short term.

• Known active uncontrolled or symptomatic central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.

• Prior treatment with any of the following:

• Everolimus or investigational anti-cancer agents in any setting

• Prior chemotherapy in the advanced setting

• Radiation within 2 weeks of randomization

• Current use or anticipated need for any prohibited food, supplements or concomitant medication(s) (ie, other anti-cancer therapies, other endocrine therapies, growth factors, chronic systemic corticosteroids, strong cytochrome P450 3A4/5 [CYP3A4/5] or uridine 5' diphosphate-glucuronosyltransferase 2B7 [UGT2B7] inhibitors and inducers, direct oral anticoagulants, proton pump inhibitors).

• Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.

Related Conditions & MeSH terms

• Advanced or Metastatic Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• PF-07220060 CDK4 inhibitor
Experimental
• Fulvestrant
Experimental and Active comparator
• Everolimus
Active Comparator
• Exemestane
Active Comparator

Locations

Country	Name	City	State
Argentina	Fundación Cenit Para La Investigación En Neurociencias	Caba	Ciudad Autónoma DE Buenos Aires
Argentina	Fundación Respirar	Ciudad Autónoma Buenos Aires
Argentina	CIPREC	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autónoma De Buenos Aires, Ciudad Autónoma D	Buenos Aires
Argentina	Fundación CORI para la Investigación y Prevención del Cáncer	La Rioja
Argentina	Sanatorio Norte	Santiago del Estero
Australia	Macquarie University	North Ryde	New South Wales
Australia	Icon Cancer Centre Townsville	Rosslea	Queensland
Australia	Icon Cancer Centre Townsville	Townsville	Queensland
Brazil	Hospital São Lucas da PUCRS	Porto Alegre	RIO Grande DO SUL
Brazil	Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador	Salvador	Bahia
Canada	Royal Victoria Regional Health Centre	Barrie	Ontario
Canada	William Osler Health System	Brampton	Ontario
Canada	CIUSSS- saguenay-Lac-Saint-Jean	Chicoutimi	Quebec
Canada	Dr. Everett Chalmers Regional Hospital	Fredericton	New Brunswick
Canada	Jewish General Hospital	Montreal	Quebec
China	Beijing Cancer hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Science	Beijing	Beijing
China	Jilin Province Tumor Hospital	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Chongqing University Cancer Hospital	Chongqing	Chongqing
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Guangxi Medical University Affiliated Tumor Hospital	Nanning	Guangxi
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Tongji Hospital Tongji Medical,Science & Technology	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
India	Kiran Hospital - Multi Super Speciality Hospital and Research Center	Surat	Gujarat
Israel	Rambam Health Care Campus	Haifa	Hatsafon
Israel	Shaare Zedek Medical Center	Jerusalem	Yerushalayim
Israel	Rabin Medical Center	Petah Tikva	Hamerkaz
Japan	St. Luke's International Hospital	Chuo-ku	Tokyo
Japan	Saitama Medical University International Medical Center	Hidaka	Saitama
Japan	Hiroshima City Hiroshima Citizens Hospital	Hiroshima
Japan	The Cancer Institute Hospital of JFCR	Koto	Tokyo
Japan	Kumamoto Shinto General Hospital	Kumamoto
Japan	Okayama University Hospital	Okayama
Japan	National Hospital Organization Osaka National Hospital	Osaka
Japan	Gunma Prefectural Cancer Center	Otashi	Gunma
Japan	National Hospital Organization Hokkaido Cancer Center	Sapporo	Hokkaido
Japan	Osaka University Hospital	Suita	Osaka
Korea, Republic of	Pusan National University Hospital	Busan	Pusan-kwangyokshi
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu	Taegu-kwangyokshi
Korea, Republic of	Inha University Hospital	Incheon	Incheon-gwangyeoksi [incheon]
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Kyonggi-do
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam-si	Kyonggi-do
Korea, Republic of	Asan Medical Center	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Kangbuk Samsung Hospital	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Korea University Guro Hospital	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Samsung Medical Center	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Ajou University Hospital	Suwon-si	Kyonggi-do
Mexico	Boca Clinical Trials Mexico S.C.	Guadajalara	Jalisco
Mexico	COI Centro Oncologico Internacional S.A.P.I. de C.V.	Mexico City	Distrito Federal
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Taipei
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Chang Gung Medical Foundation-Linkou Branch	Taoyuan
United Kingdom	Sarah Cannon Research Institute UK	London	London, CITY OF
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Intermountain Health St. Vincent Regional Hospital	Billings	Montana
United States	St. Vincent Frontier Cancer Center	Billings	Montana
United States	Danbury Hospital	Danbury	Connecticut
United States	Ascension Illinois - Evanston Infusion Center	Evanston	Illinois
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey
United States	Memorial Hermann Cancer Center	Houston	Texas
United States	Hoag Health Center Irvine	Irvine	California
United States	Hoag Hospital Irvine	Irvine	California
United States	Keck Hospital of USC	Los Angeles	California
United States	Los Angeles General Medical Center	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	Bon Secours Memorial Regional Medical Center	Mechanicsville	Virginia
United States	Bon Secours St. Francis Medical Center	Midlothian	Virginia
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Norwalk Hospital	Norwalk	Connecticut
United States	Keck Medical Center of USC Pasadena	Pasadena	California
United States	Vassar Brothers Medical Center	Poughkeepsie	New York
United States	Cancer Care Specialists	Reno	Nevada
United States	Bon Secours at St. Mary's Hospital	Richmond	Virginia
United States	Baylor Scott & White Medical Center - Round Rock	Round Rock	Texas
United States	Summit Cancer Care DBA Candler Medical Oncology Practice	Savannah	Georgia
United States	Swedish Cancer Institute	Seattle	Washington
United States	Swedish Medical Center	Seattle	Washington
United States	Ascension Illinois-Skokie Infusion Center	Skokie	Illinois
United States	Orchard Healthcare Research Inc.	Skokie	Illinois
United States	Chronic Disease Clinical Research Center (CDCRC)	Torrance	California
United States	Clinical and Translational Research Center	Torrance	California
United States	Diagnostic and Wellness Center	Torrance	California
United States	Harbor UCLA	Torrance	California
United States	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Torrance	California
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  China,  India,  Israel,  Japan,  Korea, Republic of,  Mexico,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS) progression, as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1		From Initiation up to 2 years
Secondary	Overall Survival (OS)		Time from the date of randomization to the date of death due to any cause up to approximately 5 years
Secondary	PFS as defined by investigator		Time from the date of randomization up to approximately 2 years
Secondary	OR by BICR and by investigator per RECIST v1.1		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 (up to approximately 2 years)
Secondary	Duration of Response (DOR) as define by Blinded Independent Central Review (BICR) and by investigator per RECIST v1.1		From the date of the first objective response (every 8 weeks during the first 48 weeks and then every 12 week) up to approximately 2 years.
Secondary	Number of Participants With Clinical Benefit Response (CBR) by BICR and by investigator per RECIST v1.1		From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) up to approximately 2 years
Secondary	Number or Patients with Adverse Events (AEs) by Type		From screening until 28 days after the last dose, to approximately 3 years
Secondary	Number or Patients with AEs by Incidence		From screening until 28 days after the last dose, to approximately 3 years
Secondary	Number or Patients with AEs by Seriousness		From screening until 28 days after the last dose, to approximately 3 years
Secondary	Number or Patients with AEs by relationship to study interventions		From screening until 28 days after the last dose, to approximately 3 years
Secondary	Number of Participants With Abnormal Electrocardiogram (ECG)		From baseline to approximately 2 years
Secondary	Number of Participants With Laboratory Test Abnormalities		From screening until 28 days after the last dose to approximately 2 years
Secondary	EQ-5D-5L		Screening Days 1, 15 of Cycle 1 and 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc), EoT and Safety FU until 28 days after the last dose to approximately 2 years. Each Cycle is 28 days
Secondary	EORTC QLQ		Screening Days 1, 15 of Cycle 1 and 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc), EoT and Safety FU until 28 days after the last dose to approximately 2 years. Each Cycle is 28 days
Secondary	EORTC QLQ Breast Cancer Module 23 (BR23)		Screening Days 1, 15 of Cycle 1 and 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc), EoT and Safety FU until 28 days after the last dose to approximately 2 years. Each Cycle is 28 days
Secondary	Ctrough of PF-07220060		Cycle 1 (Day 15), Cycle 2 (Day 1), and Cycle 3 (Day 1). Each Cycle is 28 days

External Links

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