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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06760637




Registration number
NCT06760637
Ethics application status
Date submitted
11/12/2024
Date registered
7/01/2025

Titles & IDs
Public title
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
Scientific title
AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO CDK4/6 INHIBITOR PLUS LETROZOLE IN PARTICIPANTS OVER 18 YEARS OF AGE WITH HORMONE RECEPTOR (HR)-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTICANCER TREATMENT FOR ADVANCED/METASTATIC DISEASE (FOURLIGHT-3)
Secondary ID [1] 0 0
2024-512925-95-00
Secondary ID [2] 0 0
C4391024
Universal Trial Number (UTN)
Trial acronym
FourLight-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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
Treatment: Drugs - letrozole
Treatment: Drugs - abemaciclib
Treatment: Drugs - palbociclib
Treatment: Drugs - ribociclib

Experimental: Arm A - PF-07220060 tablet taken by mouth plus Letrozole tablet taken by mouth

Active comparator: Arm B - Investigator's Choice of CDK4/6 inhibitor (tablet/capsule) taken by mouth with letrozole tablet taken by mouth


Treatment: Drugs: PF-07220060
CDK4 inhibitor

Treatment: Drugs: letrozole
endocrine therapy

Treatment: Drugs: abemaciclib
CDK4/6 inhibitor

Treatment: Drugs: palbociclib
CDK4/6 inhibitor

Treatment: Drugs: ribociclib
CDK4/6 inhibitor
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) by BICR
Timepoint [1] 0 0
From the date of randomization until disease progression or death due to any cause (up to approximately 4 years)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From the date of randomization until death due to any cause (up to approximately 13 years).
Secondary outcome [2] 0 0
Progression Free Survival (PFS) by Investigator
Timepoint [2] 0 0
From the date of randomization until disease progression or death due to any cause (up to approximately 4 years)
Secondary outcome [3] 0 0
OR by BICR and by investigator
Timepoint [3] 0 0
From randomization to progression or death whichever occurs first (up to approximately 4 years)
Secondary outcome [4] 0 0
Duration of Response (DoR) by BICR and by investigator
Timepoint [4] 0 0
From the date of CR or PR until objective progressive disease, or death (up to approximately 4 years)
Secondary outcome [5] 0 0
Incidence of treatment emergent treatment relatedadverse events (AE)
Timepoint [5] 0 0
Duration of the study approximately up to 13 years.
Secondary outcome [6] 0 0
Incidence of treatment emergent treatment relatedserious adverse events
Timepoint [6] 0 0
Duration of the study approximately up to 13 years.
Secondary outcome [7] 0 0
Estimated mean change from baseline in EORTC QLQ C30
Timepoint [7] 0 0
Baseline to end of treatment (up to approximately 4 years)
Secondary outcome [8] 0 0
Estimated mean change from baseline in BPI-SF
Timepoint [8] 0 0
Baseline to end of treatment (up to approximately 4 years)
Secondary outcome [9] 0 0
Estimated mean change from baseline in EQ-5D-5L
Timepoint [9] 0 0
Baseline to end of treatment (up to approximately 4 years)
Secondary outcome [10] 0 0
Estimated mean change from baseline in EORTC Breast Cancer Module (BR42)
Timepoint [10] 0 0
Baseline to end of treatment (up to approximately 4 years)
Secondary outcome [11] 0 0
Mean change from baseline of ctDNA
Timepoint [11] 0 0
Baseline to end of treatment (up to approximately 4 years)

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
* Previously untreated with any systemic anticancer therapy for their locally advanced or metastatic disease.
* Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* In visceral crisis at risk of immediately life-threatening complications in the short term.
* Current or past history of central nervous system metastases.
* Have received prior (neo)adjuvant endocrine therapy (ET) and had recurrence during or within 12 months after the last dose of ET.
* Have received prior (neo)adjuvant CDK4/6i and had recurrence during or within 12 months after the last dose of CDK4/6i.
* 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
6/01/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/12/2037
Actual
Sample size
Target
1020
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Townsville University Hospital - Douglas
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
4814 - Douglas
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Montana
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Canada
State/province [12] 0 0
New Brunswick
Country [13] 0 0
China
State/province [13] 0 0
Beijing
Country [14] 0 0
China
State/province [14] 0 0
Guangdong
Country [15] 0 0
China
State/province [15] 0 0
Hubei
Country [16] 0 0
China
State/province [16] 0 0
Jiangsu
Country [17] 0 0
China
State/province [17] 0 0
Jilin
Country [18] 0 0
China
State/province [18] 0 0
Liaoning
Country [19] 0 0
China
State/province [19] 0 0
Shaanxi
Country [20] 0 0
China
State/province [20] 0 0
Zhejiang
Country [21] 0 0
India
State/province [21] 0 0
Delhi
Country [22] 0 0
India
State/province [22] 0 0
Gujarat
Country [23] 0 0
India
State/province [23] 0 0
Maharashtra
Country [24] 0 0
Israel
State/province [24] 0 0
Hatsafon
Country [25] 0 0
Israel
State/province [25] 0 0
Tell Abib
Country [26] 0 0
Israel
State/province [26] 0 0
Yerushalayim
Country [27] 0 0
Japan
State/province [27] 0 0
Aichi
Country [28] 0 0
Japan
State/province [28] 0 0
Gunma
Country [29] 0 0
Japan
State/province [29] 0 0
Hokkaido
Country [30] 0 0
Japan
State/province [30] 0 0
Kanagawa
Country [31] 0 0
Japan
State/province [31] 0 0
Kyoto
Country [32] 0 0
Japan
State/province [32] 0 0
Miyagi
Country [33] 0 0
Japan
State/province [33] 0 0
Osaka
Country [34] 0 0
Japan
State/province [34] 0 0
Tokyo
Country [35] 0 0
Japan
State/province [35] 0 0
Chiba
Country [36] 0 0
Japan
State/province [36] 0 0
Hiroshima
Country [37] 0 0
Japan
State/province [37] 0 0
Kumamoto
Country [38] 0 0
Japan
State/province [38] 0 0
Okayama
Country [39] 0 0
Sweden
State/province [39] 0 0
Västra Götalands LÄN [se-14]
Country [40] 0 0
Switzerland
State/province [40] 0 0
Olten
Country [41] 0 0
Taiwan
State/province [41] 0 0
Hsinchu
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taipei
Country [43] 0 0
Taiwan
State/province [43] 0 0
Taoyuan

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
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06760637