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)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: The Kirklin Clinic of UAB Hospital — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (463 Sites)
Showing the first 25 of 463 sites.
- The Kirklin Clinic of UAB Hospital — Birmingham, Alabama
- The University of Alabama at Birmingham — Birmingham, Alabama
- University of Alabama at Birmingham Hospital — Birmingham, Alabama
- Ironwood Cancer & Research Centers — Chandler, Arizona
- Ironwood Cancer & Research Centers — Gilbert, Arizona
- Ironwood Cancer & Research Centers — Glendale, Arizona
- Ironwood Cancer & Research Centers — Goodyear, Arizona
- Ironwood Cancer & Research Centers — Mesa, Arizona
- Ironwood Cancer & Research Centers — Mesa, Arizona
- Ironwood Cancer & Research Centers — Phoenix, Arizona
- Ironwood Cancer & Research Centers — Scottsdale, Arizona
- CARTI Cancer Center Saline County — Bryant, Arkansas
- CARTI Cancer Center Conway — Conway, Arkansas
- Highlands Oncology — Fayetteville, Arkansas
- CARTI Cancer Center — Little Rock, Arkansas
- CARTI Cancer Center North Little Rock Urology — North Little Rock, Arkansas
- CARTI Cancer Center North Little Rock — North Little Rock, Arkansas
- CARTI Cancer Center Pine Bluff — Pine Bluff, Arkansas
- Highlands Oncology — Rogers, Arkansas
- Highlands Oncology Group — Springdale, Arkansas
- Providence Medical Foundation — Anaheim, California
- Sutter Auburn Faith Hospital — Auburn, California
- Sutter Health Alta Bates — Berkeley, California
- Cedars-Sinai Cancer Beverly Hills (drug treatment and dispensing location) — Beverly Hills, California
- Cedars-Sinai Cancer Beverly Hills — Beverly Hills, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer — Los Angeles, California
- Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery — Durham, North Carolina
- TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B) — Palo Alto, California
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- ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer — Duarte, California
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.