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

Study acronym: FourLight-3
StatusActive, Not Recruiting
PhasePhase 3
SponsorPfizer
Started

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Record History

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  1. Trial sites reduced: 463 → 460 locations
    • Eligibility criteria expanded, about 10 words
  2. Trial status changed: Recruiting → Active, Not Recruiting
    • Trial sites reduced: 518 → 463 locations
    • Enrollment target: estimated 1020 to confirmed 1035
    v8
  3. Study sites: 452 to 518v7
  4. Study sites: 255 to 452v6
  5. Study sites: 160 to 255
    • Secondary endpoints revised (11)
    v5
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  1. Study sites: 86 to 160v4
  2. Study sites: 8 to 86
    • Primary completion date: Dec 30, 2028 to Jan 2, 2029
    • Study completion date: Dec 26, 2037 to Dec 29, 2037
    v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Study sites: 6 to 8
    • Primary completion date: Jan 24, 2029 to Dec 30, 2028
    • Study completion date: Jan 20, 2038 to Dec 26, 2037
    • Start date changed from estimate of Feb 11, 2025 to Jan 6, 2025
    • Secondary endpoints revised (11)
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pfizer
438 trials monitored
See 32 trials at risk
Breast Cancer
5,455 trials monitored
See 306 trials at risk
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.
Trial Details
NCT Number NCT06760637
Lead Sponsor Pfizer
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms, Recurrence, Unilateral Breast Neoplasms
Enrollment 1,035 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov