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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06105632




Registration number
NCT06105632
Ethics application status
Date submitted
24/10/2023
Date registered
27/10/2023

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2023-506487-13-00
Secondary ID [2] 0 0
C4391022
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-07220060 CDK4 inhibitor
Treatment: Drugs - Fulvestrant
Treatment: Drugs - Everolimus
Treatment: Drugs - Exemestane

Experimental: Arm A - PF-07220060 to be taken by mouth as a tablet in combination with fulvestrant (a solution for injection)

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.


Treatment: Drugs: PF-07220060 CDK4 inhibitor
Experimental

Treatment: Drugs: Fulvestrant
Experimental and Active comparator

Treatment: Drugs: Everolimus
Active Comparator

Treatment: Drugs: Exemestane
Active Comparator
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) progression, as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [1] 0 0
From Initiation up to 2 years
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Time from the date of randomization to the date of death due to any cause up to approximately 5 years
Secondary outcome [2] 0 0
PFS as defined by investigator
Timepoint [2] 0 0
Time from the date of randomization up to approximately 2 years
Secondary outcome [3] 0 0
OR by BICR and by investigator per RECIST v1.1
Timepoint [3] 0 0
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 outcome [4] 0 0
Duration of Response (DOR) as define by Blinded Independent Central Review (BICR) and by investigator per RECIST v1.1
Timepoint [4] 0 0
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 outcome [5] 0 0
Number of Participants With Clinical Benefit Response (CBR) by BICR and by investigator per RECIST v1.1
Timepoint [5] 0 0
From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) up to approximately 2 years
Secondary outcome [6] 0 0
Number or Patients with Adverse Events (AEs) by Type
Timepoint [6] 0 0
From screening until 28 days after the last dose, to approximately 3 years
Secondary outcome [7] 0 0
Number or Patients with AEs by Incidence
Timepoint [7] 0 0
From screening until 28 days after the last dose, to approximately 3 years
Secondary outcome [8] 0 0
Number or Patients with AEs by Seriousness
Timepoint [8] 0 0
From screening until 28 days after the last dose, to approximately 3 years
Secondary outcome [9] 0 0
Number or Patients with AEs by relationship to study interventions
Timepoint [9] 0 0
From screening until 28 days after the last dose, to approximately 3 years
Secondary outcome [10] 0 0
Number of Participants With Abnormal Electrocardiogram (ECG)
Timepoint [10] 0 0
From baseline to approximately 2 years
Secondary outcome [11] 0 0
Number of Participants With Laboratory Test Abnormalities
Timepoint [11] 0 0
From screening until 28 days after the last dose to approximately 2 years
Secondary outcome [12] 0 0
EQ-5D-5L
Timepoint [12] 0 0
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 outcome [13] 0 0
EORTC QLQ
Timepoint [13] 0 0
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 outcome [14] 0 0
EORTC QLQ Breast Cancer Module 23 (BR23)
Timepoint [14] 0 0
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 outcome [15] 0 0
Ctrough of PF-07220060
Timepoint [15] 0 0
Cycle 1 (Day 15), Cycle 2 (Day 1), and Cycle 3 (Day 1). Each Cycle is 28 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/12/2028
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Macquarie University - North Ryde
Recruitment hospital [2] 0 0
Icon Cancer Centre Townsville - Rosslea
Recruitment hospital [3] 0 0
Icon Cancer Centre Townsville - Townsville
Recruitment postcode(s) [1] 0 0
2109 - North Ryde
Recruitment postcode(s) [2] 0 0
4812 - Rosslea
Recruitment postcode(s) [3] 0 0
4812 - Townsville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
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California
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Connecticut
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District of Columbia
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Georgia
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Illinois
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Iowa
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Maryland
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Mississippi
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Montana
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Nevada
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New Jersey
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New York
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Texas
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Virginia
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma DE Buenos Aires
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Argentina
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RÍO Negro
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Santa FE
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Tucumán
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Córdoba
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La Rioja
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Santiago del Estero
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Bahia
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RIO Grande DO Norte
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Brazil
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Brazil
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SÃO Paulo
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Nova Scotia
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Ontario
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Chile
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Región Metropolitana DE Santiago
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China
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Anhui
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China
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Beijing
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China
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China
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China
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China
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China
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Hunan
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Jilin
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Liaoning
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Zhejiang
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Delhi
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Gujarat
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Rajasthan
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India
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WEST Bengal
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Israel
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Hadarom
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Israel
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Hamerkaz
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Israel
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Hatsafon
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Israel
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Aichi
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Distrito Federal
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Jalisco
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Nuevo LEÓN
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Mexico
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Chihuahua
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Mexico
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Oaxaca
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Mexico
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Veracruz
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Switzerland
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Aargau
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Switzerland
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Olten
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Turkey
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I?stanbul
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Turkey
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I?zmir
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Turkey
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Ankara
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Turkey
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Diyarbakir
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Turkey
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Kayseri
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Turkey
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Kocaeli
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Turkey
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Konya
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Turkey
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Samsun
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United Kingdom
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England
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United Kingdom
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Hammersmith AND Fulham
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United Kingdom
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London, CITY OF
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United Kingdom
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Midlothian
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Warwickshire
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United Kingdom
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Guildford
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Manchester
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United Kingdom
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Swindon

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
ClinicalTrials.gov_Inquiries@pfizer.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06105632