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Study of PF-07224826, as a Single Agent or in Combination With Endocrine Therapy in Participants With Breast Cancer and Other Advanced Solid Tumors.

Primary Purpose

Breast Cancer, Ovarian Cancer, Liposarcoma

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
PF-07224826
Fulvestrant
PF-07224826
Fulvestrant
PF-07224826
Fulvestrant
PF-07224826
Fulvestrant
PF-07224826
Fulvestrant
PF-07224826
Fulvestrant
PF-07224826
Fulvestrant
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring cyclin-dependent kinase 2 (CDK2), cyclin-dependent kinase 4 (CDK4), cyclin-dependent kinase 6 (CDK6), hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Part 1: Participants with HR-positive HER2-negative locally advanced or metastatic breast cancer. Participants with locally recurrent/advanced or metastatic TNBC. Participants with advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC). Other advanced solid tumor types: Tumors other than BC or Ovarian: NSCLC, prostate, endometrial, liposarcoma, or other tumors with cyclin D (CCND) and cyclin E (CCNE) implicated in pathogenesis either by gene amplification or overexpression. Part 2 (Arm A): Participants with HR positive HER2 negative locally advanced or mBC (post CDK4/6 inhibitors). Part 2 (Arm B): Participants with HR positive HER2 negative locally advanced or mBC (naïve to CDK4/6 inhibitors). Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. Adequate Bone Marrow Function Exclusion Criteria: Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, Cerebral edema, and/or progressive growth. Participants with a history of CNS metastases or cord compression are eligible if they have been definitively treated (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before enrollment and have no evidence of progression at time of study enrollment. Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (eg, including participants with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement). Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ. Last anticancer treatment within 2 weeks (or 5 half-lives, whichever is shorter), unless the last immediate anticancer treatment contained an antibody-based agent(s) (approved or investigational), then the interval of 4 weeks or 5 half-lives (whichever is shorter) is required prior to receiving the study intervention.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Part 1 Dose Escalation-Dose Level 1

    Part 1 Dose Escalation-Dose Level 2

    Part 1 Dose Escalation-Dose Level 3

    Part 1 Dose Escalation-Dose Level 4

    Part 1 Dose Escalation-Dose Level 5

    Part 2 - Arm A

    Part 2 - Arm B

    Arm Description

    In Part 1, participants with locally recurrent/advanced or metastatic TNBC, platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. PF-07224826 will be administered orally, once daily, on a continuous basis.

    In Part 1, participants with locally recurrent/advanced or metastatic TNBC, platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. PF-07224826 will be administered orally, once daily, on a continuous basis.

    In Part 1, participants with locally recurrent/advanced or metastatic TNBC, platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. PF-07224826 will be administered orally, once daily, on a continuous basis.

    In Part 1, participants with locally recurrent/advanced or metastatic TNBC, platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. PF-07224826 will be administered orally, once daily, on a continuous basis.

    In Part 1, participants with locally recurrent/advanced or metastatic TNBC, platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. PF-07224826 will be administered orally, once daily, on a continuous basis.

    In Part 2 Arm A, PF-07224826 will be evaluated in combination with fulvestrant in HR positive HER2 negative advanced or mBC participants who have received prior CDK4/6 inhibitor. PF-07224826 will be administered orally, once daily, on a continuous basis.

    In Part 2 Arm B, PF-07224826 will be evaluated in combination with fulvestrant in HR-positive HER2-negative locally advanced or mBC participants whose disease has progressed on prior endocrine therapy and is naïve to CDK4/6 inhibitors. PF-07224826 will be administered orally, once daily, on a continuous basis.

    Outcomes

    Primary Outcome Measures

    Part 1: First cycle dose limiting toxicities (DLTs)
    Part 1 and Part 2: Adverse events (AEs) as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0), timing, seriousness and relationship to study therapy.
    Part 1 and Part 2: Number of participants with Clinical Laboratory abnormalities
    Part 1 and Part 2: Incidence of clinically significant abnormal vital signs.
    Part 2: Preliminary antitumor activity measure for efficacy includes ORR, as assessed using RECIST version 1.1.
    Part 1 and Part 2: Incidence of clinically significant abnormal ECGs.

    Secondary Outcome Measures

    Part1 and Part 2: Maximum Observed Plasma Concentration (Cmax); Single Dose (SD)
    Part 1 and Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax); Single Dose (SD)
    Part 1: Area under the concentration-time curve from 0 to time of last measurable concentration (AUClast)
    Part 1 and Part 2: Maximum Observed Plasma concentration (Cmax,ss), steady state
    Part 1 and Part 2: Time to Reach Maximum Observed Plasma Concentration steady state (Tmax, ss)
    Part 1 and Part 2: Minimum Observed Plasma Concentration (Cmin, ss), steady state
    Part 1: Area Under the concentration-time curve from 0 to time the end of the dosing interval (AUCtau,ss), steady state
    Part 2: Accumulation ratio (Rac)
    Part 1: Objective Response, as assessed using RECIST version 1.1.
    Part 1 and Part 2: Duration of Response (DoR) of PF-07224826 alone or in combination with fulvestrant
    Part 1 and Part 2: Progression-Free Survival (PFS) of PF-07224826 alone or in combination with fulvestrant
    Part 1 and Part 2: Time to Response (TTR) of PF-07224826 alone or in combination with fulvestrant
    Part 2: Overall Survival (OS) of PF-07224826 with fulvestrant
    Part 2: Clinical benefit response (CBR) of PF-07224826 with fulvestrant
    Part 1 and Part 2: Expression of Pharmacodynamic (PD) biomarkers in tumor tissue

    Full Information

    First Posted
    May 24, 2023
    Last Updated
    July 31, 2023
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05905341
    Brief Title
    Study of PF-07224826, as a Single Agent or in Combination With Endocrine Therapy in Participants With Breast Cancer and Other Advanced Solid Tumors.
    Official Title
    A PHASE 1, OPEN-LABEL, MULTICENTER, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTITUMOR ACTIVITY OF PF-07224826, AS A SINGLE AGENT AND IN COMBINATION WITH ENDOCRINE THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 15, 2024 (Anticipated)
    Primary Completion Date
    April 14, 2026 (Anticipated)
    Study Completion Date
    April 13, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pfizer

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This is a Phase 1, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of PF-07224826, as a single agent or in combination with endocrine therapy in participants with advanced solid tumors. This study will be divided into dose escalation/finding (Part 1) and dose expansion (Part 2). In Part 1, participants with locally recurrent/advanced or metastatic Triple Negative Breast Cancer (TNBC), platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. In Part 2 (Arm A), PF-07224826 will be evaluated in combination with fulvestrant in HR-positive HER2-negative advanced or mBC participants who have received prior CDK4/6 inhibitor. In Part 2 (Arm B), PF-07224826 will be evaluated in combination with fulvestrant in HR-positive HER2-negative locally advanced or mBC participants whose disease has progressed on prior endocrine therapy and is naïve to CDK4/6 inhibitors.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Ovarian Cancer, Liposarcoma, Non-small Cell Lung Cancer (NSCLC), Endometrial, Solid Tumors
    Keywords
    cyclin-dependent kinase 2 (CDK2), cyclin-dependent kinase 4 (CDK4), cyclin-dependent kinase 6 (CDK6), hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    110 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Part 1 Dose Escalation-Dose Level 1
    Arm Type
    Experimental
    Arm Description
    In Part 1, participants with locally recurrent/advanced or metastatic TNBC, platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. PF-07224826 will be administered orally, once daily, on a continuous basis.
    Arm Title
    Part 1 Dose Escalation-Dose Level 2
    Arm Type
    Experimental
    Arm Description
    In Part 1, participants with locally recurrent/advanced or metastatic TNBC, platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. PF-07224826 will be administered orally, once daily, on a continuous basis.
    Arm Title
    Part 1 Dose Escalation-Dose Level 3
    Arm Type
    Experimental
    Arm Description
    In Part 1, participants with locally recurrent/advanced or metastatic TNBC, platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. PF-07224826 will be administered orally, once daily, on a continuous basis.
    Arm Title
    Part 1 Dose Escalation-Dose Level 4
    Arm Type
    Experimental
    Arm Description
    In Part 1, participants with locally recurrent/advanced or metastatic TNBC, platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. PF-07224826 will be administered orally, once daily, on a continuous basis.
    Arm Title
    Part 1 Dose Escalation-Dose Level 5
    Arm Type
    Experimental
    Arm Description
    In Part 1, participants with locally recurrent/advanced or metastatic TNBC, platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. PF-07224826 will be administered orally, once daily, on a continuous basis.
    Arm Title
    Part 2 - Arm A
    Arm Type
    Experimental
    Arm Description
    In Part 2 Arm A, PF-07224826 will be evaluated in combination with fulvestrant in HR positive HER2 negative advanced or mBC participants who have received prior CDK4/6 inhibitor. PF-07224826 will be administered orally, once daily, on a continuous basis.
    Arm Title
    Part 2 - Arm B
    Arm Type
    Experimental
    Arm Description
    In Part 2 Arm B, PF-07224826 will be evaluated in combination with fulvestrant in HR-positive HER2-negative locally advanced or mBC participants whose disease has progressed on prior endocrine therapy and is naïve to CDK4/6 inhibitors. PF-07224826 will be administered orally, once daily, on a continuous basis.
    Intervention Type
    Drug
    Intervention Name(s)
    PF-07224826
    Intervention Description
    Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Fulvestrant
    Intervention Description
    Competitive ER antagonist, to be administered by intramuscular injection (prefilled syringe).
    Intervention Type
    Drug
    Intervention Name(s)
    PF-07224826
    Intervention Description
    Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Fulvestrant
    Intervention Description
    Competitive ER antagonist, to be administered by intramuscular injection (prefilled syringe).
    Intervention Type
    Drug
    Intervention Name(s)
    PF-07224826
    Intervention Description
    Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Fulvestrant
    Intervention Description
    Competitive ER antagonist, to be administered by intramuscular injection (prefilled syringe).
    Intervention Type
    Drug
    Intervention Name(s)
    PF-07224826
    Intervention Description
    Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Fulvestrant
    Intervention Description
    Competitive ER antagonist, to be administered by intramuscular injection (prefilled syringe).
    Intervention Type
    Drug
    Intervention Name(s)
    PF-07224826
    Intervention Description
    Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Fulvestrant
    Intervention Description
    Competitive ER antagonist, to be administered by intramuscular injection (prefilled syringe).
    Intervention Type
    Drug
    Intervention Name(s)
    PF-07224826
    Intervention Description
    Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Fulvestrant
    Intervention Description
    Competitive ER antagonist, to be administered by intramuscular injection (prefilled syringe).
    Intervention Type
    Drug
    Intervention Name(s)
    PF-07224826
    Intervention Description
    Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Fulvestrant
    Intervention Description
    Competitive ER antagonist, to be administered by intramuscular injection (prefilled syringe).
    Primary Outcome Measure Information:
    Title
    Part 1: First cycle dose limiting toxicities (DLTs)
    Time Frame
    Cycle 1 (28 days)
    Title
    Part 1 and Part 2: Adverse events (AEs) as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0), timing, seriousness and relationship to study therapy.
    Time Frame
    From the first dose to earliest of 28 days post last dosing date or day of new anticancer therapy -1 day.
    Title
    Part 1 and Part 2: Number of participants with Clinical Laboratory abnormalities
    Time Frame
    From the first dose to earliest of 28 days post last dosing date or day of new anticancer therapy -1 day.
    Title
    Part 1 and Part 2: Incidence of clinically significant abnormal vital signs.
    Time Frame
    From the first dose to earliest of 28 days post last dosing date or day of new anticancer therapy -1 day.
    Title
    Part 2: Preliminary antitumor activity measure for efficacy includes ORR, as assessed using RECIST version 1.1.
    Time Frame
    From baseline until the date of first documented progression, or date of death of any cause, or date of withdrawal of consent, or date of lost to follow-up, whichever came first.
    Title
    Part 1 and Part 2: Incidence of clinically significant abnormal ECGs.
    Time Frame
    From the first dose to earliest of 28 days post last dosing date or day of new anticancer therapy -1 day.
    Secondary Outcome Measure Information:
    Title
    Part1 and Part 2: Maximum Observed Plasma Concentration (Cmax); Single Dose (SD)
    Time Frame
    Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
    Title
    Part 1 and Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax); Single Dose (SD)
    Time Frame
    Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
    Title
    Part 1: Area under the concentration-time curve from 0 to time of last measurable concentration (AUClast)
    Time Frame
    Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
    Title
    Part 1 and Part 2: Maximum Observed Plasma concentration (Cmax,ss), steady state
    Time Frame
    Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
    Title
    Part 1 and Part 2: Time to Reach Maximum Observed Plasma Concentration steady state (Tmax, ss)
    Time Frame
    Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
    Title
    Part 1 and Part 2: Minimum Observed Plasma Concentration (Cmin, ss), steady state
    Time Frame
    Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
    Title
    Part 1: Area Under the concentration-time curve from 0 to time the end of the dosing interval (AUCtau,ss), steady state
    Time Frame
    Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
    Title
    Part 2: Accumulation ratio (Rac)
    Time Frame
    Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
    Title
    Part 1: Objective Response, as assessed using RECIST version 1.1.
    Time Frame
    From baseline and up to approximately 24 months
    Title
    Part 1 and Part 2: Duration of Response (DoR) of PF-07224826 alone or in combination with fulvestrant
    Time Frame
    From baseline and up to approximately 24 months
    Title
    Part 1 and Part 2: Progression-Free Survival (PFS) of PF-07224826 alone or in combination with fulvestrant
    Time Frame
    From baseline and up to approximately 24 months
    Title
    Part 1 and Part 2: Time to Response (TTR) of PF-07224826 alone or in combination with fulvestrant
    Time Frame
    From baseline and up to approximately 24 months
    Title
    Part 2: Overall Survival (OS) of PF-07224826 with fulvestrant
    Time Frame
    From baseline and up to approximately 24 months
    Title
    Part 2: Clinical benefit response (CBR) of PF-07224826 with fulvestrant
    Time Frame
    From baseline and up to approximately 24 months
    Title
    Part 1 and Part 2: Expression of Pharmacodynamic (PD) biomarkers in tumor tissue
    Time Frame
    From baseline and up to approximately 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Part 1: Participants with HR-positive HER2-negative locally advanced or metastatic breast cancer. Participants with locally recurrent/advanced or metastatic TNBC. Participants with advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC). Other advanced solid tumor types: Tumors other than BC or Ovarian: NSCLC, prostate, endometrial, liposarcoma, or other tumors with cyclin D (CCND) and cyclin E (CCNE) implicated in pathogenesis either by gene amplification or overexpression. Part 2 (Arm A): Participants with HR positive HER2 negative locally advanced or mBC (post CDK4/6 inhibitors). Part 2 (Arm B): Participants with HR positive HER2 negative locally advanced or mBC (naïve to CDK4/6 inhibitors). Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. Adequate Bone Marrow Function Exclusion Criteria: Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, Cerebral edema, and/or progressive growth. Participants with a history of CNS metastases or cord compression are eligible if they have been definitively treated (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before enrollment and have no evidence of progression at time of study enrollment. Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (eg, including participants with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement). Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ. Last anticancer treatment within 2 weeks (or 5 half-lives, whichever is shorter), unless the last immediate anticancer treatment contained an antibody-based agent(s) (approved or investigational), then the interval of 4 weeks or 5 half-lives (whichever is shorter) is required prior to receiving the study intervention.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pfizer CT.gov Call Center
    Phone
    1-800-718-1021
    Email
    ClinicalTrials.gov_Inquiries@pfizer.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing 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.
    Links:
    URL
    https://pmiform.com/clinical-trial-info-request?StudyID=C5331001
    Description
    To obtain contact information for a study center near you, click here.

    Learn more about this trial

    Study of PF-07224826, as a Single Agent or in Combination With Endocrine Therapy in Participants With Breast Cancer and Other Advanced Solid Tumors.

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