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

Running, not enrolling · Phase 3

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT06760637

Run by

Pfizer

People needed

1035

Starts

2025-01-06

Expected to finish

2037-12-29

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Alabama at Birmingham Hospital — Birmingham, Alabama, United States
• Ironwood Cancer & Research Centers — Chandler, Arizona, United States
• Ironwood Cancer & Research Centers — Gilbert, Arizona, United States
• Ironwood Cancer & Research Centers — Glendale, Arizona, United States
• Ironwood Cancer & Research Centers — Goodyear, Arizona, United States
• Ironwood Cancer & Research Centers — Mesa, Arizona, United States
• Ironwood Cancer & Research Centers — Mesa, Arizona, United States
• Ironwood Cancer & Research Centers — Phoenix, Arizona, United States
• Ironwood Cancer & Research Centers — Scottsdale, Arizona, United States
• CARTI Cancer Center Saline County — Bryant, Arkansas, United States
• CARTI Cancer Center Conway — Conway, Arkansas, United States
• Highlands Oncology — Fayetteville, Arkansas, United States
• CARTI Cancer Center — Little Rock, Arkansas, United States
• CARTI Cancer Center North Little Rock Urology — North Little Rock, Arkansas, United States
• CARTI Cancer Center North Little Rock — North Little Rock, Arkansas, United States
• CARTI Cancer Center Pine Bluff — Pine Bluff, Arkansas, United States
• Highlands Oncology — Rogers, Arkansas, United States
• Highlands Oncology Group — Springdale, Arkansas, United States
• Providence Medical Foundation — Anaheim, California, United States
• Sutter Auburn Faith Hospital — Auburn, California, United States
• Sutter Health Alta Bates — Berkeley, California, United States
• Cedars-Sinai Cancer Beverly Hills (drug treatment and dispensing location) — Beverly Hills, California, United States
• Cedars-Sinai Cancer Beverly Hills — Beverly Hills, California, United States
• The Kirklin Clinic of UAB Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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