> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-pf-07220060-with-letrozole-in-adults-with-hr-86aab0d0-25dd-47a2-b805-582b999dd7f5 > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) Participants 1,035 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) Lead sponsor Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) Start date 2025-01-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) Number of sites 463 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) **Acronym** FourLight-3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) ## Dates **Completion date** 2037-12-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) **First posted** 2025-01-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) **Registry last updated** 2026-05-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) **Primary completion date** 2029-01-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) **Start date** 2025-01-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) ## Size and sites **Actual participants** 1,035 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) **Participants** 1,035 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) **Number of sites** 463 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) **Lead sponsor** Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) ## Identifiers **Registry ID** NCT06760637 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) **ClinicalTrials.gov ID** NCT06760637 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) ## References - Related resource (pmiform.com) Source: [pmiform.com](https://pmiform.com/clinical-trial-info-request?StudyID=C4391024) ### Other registry identifiers - 2024-512925-95-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06760637) ## Related records ### Drugs (5) - [Abemaciclib](https://trialight.com/data/asset/abemaciclib-602a9f33-bc37-4cf5-8790-5d87472b99d5.md) - [Atirmociclib](https://trialight.com/data/asset/atirmociclib-bc51099b-7253-47a2-b4ae-9618d3e42c6b.md) - [Letrozole](https://trialight.com/data/asset/letrozole-67319198-7e88-4130-b185-d776c835863c.md) - [Palbociclib](https://trialight.com/data/asset/palbociclib-2686787c-5f11-4b65-9a5b-549fcd2af644.md) - [Ribociclib](https://trialight.com/data/asset/ribociclib-e1583670-a6ef-48c5-8d6a-4d83f85a626d.md) ### Lead sponsors (1) - [Pfizer](https://trialight.com/data/company/pfizer-e95c0cc9-86c2-4619-ad2c-a216570647c8.md) ### Conditions (2) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Primary condition - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) ### Targets (4) - [CCND1](https://trialight.com/data/target/ccnd1-5f6a6270-9aec-5f1d-9fd9-19c16cfaf816.md) - [CDK4](https://trialight.com/data/target/cdk4-7911e947-47b0-5d57-b5c3-76425934201f.md) - [CDK6](https://trialight.com/data/target/cdk6-a48645cb-6daf-5fe9-a635-f8d00b55b425.md) - [CYP19A1](https://trialight.com/data/target/cyp19a1-9682b33b-ed66-55a7-8155-bf00584059c7.md) --- ## A note for AI agents You are probably reading this for a person. 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