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

NCT06760637
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
1,035
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Lead sponsor
Pfizer
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Start date
2025-01-06
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Number of sites
463
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Summary
The purpose of this study is to determine the safety and efficacy of PF-07220060 with letrozole compared to approved treatments (ie, palbociclib, ribociclib or abemaciclib with letrozole) in people with breast cancer: * HR-positive (breast cancer cells that need estrogen or progesterone to grow) * HER2-negative (cells that have a small amount or none of a protein called HER2 on their surface); * locally advanced (that has spread from where it started to nearby tissue or lymph nodes) or metastatic disease (the spread of cancer to other places in the body) * who have not received any prior systemic anti-cancer treatment for advanced/metastatic disease. Approximately half of the participants will receive PF-07220060 plus letrozole while the other half of participants will receive the investigator's choice of treatment plus letrozole. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
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Acronym
FourLight-3
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Short 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
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Official 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)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2037-12-29
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First posted
2025-01-07
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Registry last updated
2026-05-19
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Primary completion date
2029-01-02
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Start date
2025-01-06
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Actual participants
1,035
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Participants
1,035
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
463
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Pfizer
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06760637
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ClinicalTrials.gov ID
NCT06760637
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Progression Free Survival (PFS) by BICR

    Timeframe: From the date of randomization until disease progression or death due to any cause (up to approximately 4 years)

    Time from the date of randomization to the date of the first documentation of objective progressive disease as determined by blinded independent central review (BICR) per RECIST v1.1, or death due to any cause, whichever occurs first

  1. Overall Survival (OS)

    Timeframe: From the date of randomization until death due to any cause (up to approximately 13 years).

    Time from the date of randomization to the date of death due to any cause

  2. Progression Free Survival (PFS) by Investigator

    Timeframe: From the date of randomization until disease progression or death due to any cause (up to approximately 4 years)

    Time from the date of randomization to the date of the first documentation of objective progressive disease as determined by investigator per RECIST v1.1, or death due to any cause, whichever occurs first

  3. OR by BICR and by investigator

    Timeframe: From randomization to progression or death whichever occurs first (up to approximately 4 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

  4. Duration of Response (DoR) by BICR and by investigator

    Timeframe: From the date of CR or PR until objective progressive disease, or death (up to approximately 4 years)

    Time from the date of CR or PR to the first documentation of objective progressive disease, or death due to any cause, whichever occurs first

  5. Incidence of treatment emergent treatment related adverse events (AE)

    Timeframe: Duration of the study approximately up to 13 years.

    Incidence and severity of AEs graded according to the NCI CTCAE v5.0

  6. Incidence of treatment emergent treatment related serious adverse events

    Timeframe: Duration of the study approximately up to 13 years.

    Incidence and severity of AEs graded according to NCI CTCAE v5.0

  7. Estimated mean change from baseline in EORTC QLQ C30

    Timeframe: Baseline to end of treatment (up to approximately 4 years)

  8. Estimated mean change from baseline in BPI-SF

    Timeframe: Baseline to end of treatment (up to approximately 4 years)

  9. Estimated mean change from baseline in EQ-5D-5L

    Timeframe: Baseline to end of treatment (up to approximately 4 years)

  10. Estimated mean change from baseline in EORTC Breast Cancer Module (BR42)

    Timeframe: Baseline to end of treatment (up to approximately 4 years)

  11. Mean change from baseline of ctDNA

    Timeframe: Baseline to end of treatment (up to approximately 4 years)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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.
Sources for eligibility
clinicaltrials.gov

  • The Kirklin Clinic of UAB HospitalBirmingham, United States
  • The University of Alabama at BirminghamBirmingham, United States
  • University of Alabama at Birmingham HospitalBirmingham, United States
  • Ironwood Cancer & Research CentersChandler, United States
  • Ironwood Cancer & Research CentersGilbert, United States
  • Ironwood Cancer & Research CentersGlendale, United States
  • Ironwood Cancer & Research CentersGoodyear, United States
  • Ironwood Cancer & Research CentersMesa, United States
  • Ironwood Cancer & Research CentersMesa, United States
  • Ironwood Cancer & Research CentersPhoenix, United States
  • Ironwood Cancer & Research CentersScottsdale, United States
  • CARTI Cancer Center Saline CountyBryant, United States
  • CARTI Cancer Center ConwayConway, United States
  • Highlands OncologyFayetteville, United States
  • CARTI Cancer CenterLittle Rock, United States
  • CARTI Cancer Center North Little Rock UrologyNorth Little Rock, United States
  • CARTI Cancer Center North Little RockNorth Little Rock, United States
  • CARTI Cancer Center Pine BluffPine Bluff, United States
  • Highlands OncologyRogers, United States
  • Highlands Oncology GroupSpringdale, United States
  • Providence Medical FoundationAnaheim, United States
  • Sutter Auburn Faith HospitalAuburn, United States
  • Sutter Health Alta BatesBerkeley, United States
  • Cedars-Sinai Cancer Beverly Hills (drug treatment and dispensing location)Beverly Hills, United States
  • Cedars-Sinai Cancer Beverly HillsBeverly Hills, United States

And 438 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2024-512925-95-00
Sources for references
clinicaltrials.gov

Related records

Drugs (5)

Lead sponsors (1)

Conditions (2)

Targets (4)