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OncoMatch/Clinical Trials/NCT06760637

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

Is NCT06760637 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for breast cancer.

Phase 3RecruitingPfizerNCT06760637Data as of May 2026

Treatment: PF-07220060 · letrozole · abemaciclib · palbociclib · ribociclibThe 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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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) negative

Required: ESR1 positive

Required: PR (PGR) positive

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: endocrine therapy

Exception: adjuvant/neoadjuvant ET allowed if recurrence occurred >12 months after last dose

Have received prior (neo)adjuvant endocrine therapy (ET) and had recurrence during or within 12 months after the last dose of ET

Cannot have received: CDK4/6 inhibitor

Exception: adjuvant/neoadjuvant CDK4/6i allowed if recurrence occurred >12 months after last dose

Have received prior (neo)adjuvant CDK4/6i and had recurrence during or within 12 months after the last dose of CDK4/6i

Lab requirements

Blood counts

No hematologic abnormalities

Kidney function

No inadequate renal function

Liver function

No hepatic dysfunction

Inadequate renal function, hepatic dysfunction, or hematologic abnormalities

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial 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

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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