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 14, 2028

Study information

• Verified date: April 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 14, 2028
• Est. primary completion date: December 16, 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	CIPREC	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Fundación CORI para la Investigación y Prevención del Cáncer	La Rioja
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
Canada	Dr. Everett Chalmers Regional Hospital	Fredericton	New Brunswick
Israel	Rambam Health Care Campus	Haifa	Hatsafon
Israel	Shaare Zedek Medical Center	Jerusalem	Yerushalayim
Japan	Osaka University Hospital	Suita	Osaka
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu	Taegu-kwangyokshi
Korea, Republic of	Inha University Hospital	Incheon	Incheon-gwangyeoksi [incheon]
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Kangbuk Samsung Hospital	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul	Seoul-teukbyeolsi [seoul]
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Taipei
Taiwan	National Taiwan University Hospital	Taipei
United States	St. Vincent Frontier Cancer Center	Billings	Montana
United States	St. Vincent HealthCare	Billings	Montana
United States	Danbury Hospital	Danbury	Connecticut
United States	Ascension Illinois - Evanston Infusion Center	Evanston	Illinois
United States	Norwalk Hospital	Norwalk	Connecticut
United States	Vassar Brothers Medical Center	Poughkeepsie	New York
United States	Summit Cancer Care DBA Candler Medical Oncology Practice	Savannah	Georgia
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,  Israel,  Japan,  Korea, Republic of,  Taiwan, 

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.