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

August 19, 2026 updated by: Pfizer

AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 2 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATOR'S CHOICE OF THERAPY IN PARTICIPANTS AT LEAST 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 (FOURLIGHT-1)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
333

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Córdoba, Argentina, X5004FHP
        • Clinica Universitaria Reina Fabiola
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1061
        • CIPREC
    • Río Negro Province
      • Viedma, Río Negro Province, Argentina, R8500ACE
        • Clinica Viedma S. A
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000KZE
        • Instituto de Oncologia de Rosario
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Centro Para la Atención Integral del Paciente Oncologico (CAIPO)
  • Australia
    • Queensland
      • Rosslea, Queensland, Australia, 4812
        • Icon Cancer Centre Townsville
  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50070-480
        • Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Pernambuco
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59062-000
        • Liga Norte Riograndense Contra o Câncer
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Hospital Sao Lucas da PUCRS
  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Royal Victoria Regional Health Centre
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • CIUSSS- saguenay-Lac-Saint-Jean
  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center
  • India
    • Maharashtra
      • Pune, Maharashtra, India, 411004
        • Sahyadri Super Speciality Hospital
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110085
        • Rajiv Gandhi Cancer Institute and Research Centre
  • Israel
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
    • Northern District
      • Haifa, Northern District, Israel, 3109601
        • Rambam Health Care Campus
  • Japan
      • Chiba, Japan, 260-8717
        • Chiba Cancer Center
      • Hiroshima, Japan, 730-8518
        • Hiroshima City Hiroshima Citizens Hospital
      • Osaka, Japan, 540-0006
        • National Hospital Organization Osaka National Hospital
    • Gunma
      • Otashi, Gunma, Japan, 373-8550
        • Gunma Prefectural Cancer Center
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Osaka University Hospital
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-8560
        • St. Luke's International Hospital
  • Mexico
      • Oaxaca City, Mexico, 68000
        • Oaxaca Site Management Organization S.C.
      • Veracruz, Mexico, 91851
        • Instituto Veracruzano en Investigación Clínica S.C.
    • Mexico City
      • Mexico City, Mexico City, Mexico, 04700
        • COI Centro Oncologico Internacional S.A.P.I. de C.V.
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Filios Alta Medicina S.A. de C.V.
  • South Korea
    • Kyǒnggi-do
      • Suwon, Kyǒnggi-do, South Korea, 16499
        • Ajou University Hospital
    • Seoul-teukbyeolsi [seoul]
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080
        • Seoul National University Hospital
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06273
        • Gangnam Severance Hospital, Yonsei University Health System
  • Taiwan
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation-Linkou Branch
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06010
        • Gulhane Egitim Arastirma Hastanesi
      • Ankara, Turkey (Türkiye), 06420
        • Ultramar Medical Imaging Center
      • Ankara, Turkey (Türkiye), 06530
        • Ultramar Medical Imaging Center
    • İ̇stanbul
      • Stanbul, İ̇stanbul, Turkey (Türkiye), 34214
        • Medipol Mega Üniversite Hastanesi
  • United Kingdom
      • London, United Kingdom, W68RF
        • Imperial College Healthcare NHS Trust, Charing Cross Hospital
    • London, CITY of
      • London, London, CITY of, United Kingdom, w1g 6ad
        • Sarah Cannon Research Institute UK
  • United States
    • California
      • Irvine, California, United States, 92618
        • Hoag Hospital Irvine
      • Irvine, California, United States, 92618
        • Hoag Health Center Irvine
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90033
        • Keck Hospital of USC
      • Los Angeles, California, United States, 90033
        • Los Angeles General Medical Center
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital Presbyterian
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Medstar Washington Hospital Center
    • Montana
      • Billings, Montana, United States, 59101
        • Intermountain Health St. Vincent Regional Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Memorial Hermann Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A
PF-07220060 to be taken by mouth as a tablet in combination with fulvestrant (a solution for injection)
Drug: Fulvestrant
Experimental and Active comparator
Drug: PF-07220060 CDK4 inhibitor
Experimental
Active Comparator: Arm B

Investigator's choice of therapy of either:

  • Fulvestrant alone (a solution for injection), or
  • Everolimus in combination with exemestane, both a tablet to be taken by mouth.
Drug: Everolimus
Active Comparator
Drug: Fulvestrant
Experimental and Active comparator
Drug: Exemestane
Active Comparator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Progression-Free Survival (PFS) progression, as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame: From Initiation up to 2 years
From Initiation up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Time from the date of randomization to the date of death due to any cause up to approximately 3 years
Time from the date of randomization to the date of death due to any cause up to approximately 3 years
Number or Patients with Adverse Events (AEs) by Type
Time Frame: From screening until 28 days after the last dose, to approximately 3 years
From screening until 28 days after the last dose, to approximately 3 years
Number or Patients with AEs by Incidence
Time Frame: From screening until 28 days after the last dose, to approximately 3 years
From screening until 28 days after the last dose, to approximately 3 years
Number or Patients with AEs by Seriousness
Time Frame: From screening until 28 days after the last dose, to approximately 3 years
From screening until 28 days after the last dose, to approximately 3 years
Number or Patients with AEs by relationship to study interventions
Time Frame: From screening until 28 days after the last dose, to approximately 3 years
From screening until 28 days after the last dose, to approximately 3 years
Number of Participants With Abnormal Electrocardiogram (ECG)
Time Frame: From baseline to approximately 2 years
From baseline to approximately 2 years
Number of Participants With Laboratory Test Abnormalities
Time Frame: From screening until 28 days after the last dose to approximately 2 years
From screening until 28 days after the last dose to approximately 2 years
Ctrough of PF-07220060
Time Frame: Cycle 1 (Day 15), Cycle 2 (Day 1), and Cycle 3 (Day 1). Each Cycle is 28 days
Cycle 1 (Day 15), Cycle 2 (Day 1), and Cycle 3 (Day 1). Each Cycle is 28 days
OR by investigator per RECIST v1.1
Time Frame: 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)
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)
Duration of Response (DOR) as defined by investigator per RECIST v1.1
Time Frame: 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.
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.
Number of Participants With Clinical Benefit Response (CBR) by investigator per RECIST v1.1
Time Frame: From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) up to approximately 2 years
From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) up to approximately 2 years
EQ-5D-5L
Time Frame: 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) and EoT. Each Cycle is 28 days.
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) and EoT. Each Cycle is 28 days.
EORTC QLQ
Time Frame: 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) and EoT. Each Cycle is 28 days.
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) and EoT. Each Cycle is 28 days.
EORTC QLQ Breast Cancer Module 23 (BR23)
Time Frame: 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) and EoT. Each Cycle is 28 days.
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) and EoT. Each Cycle is 28 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 12, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 21, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C4391022
  • 2023-506487-13-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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