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Treatment for advanced breast cancer using PF-07220060 and letrozole

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)

Phase 3 Interventional Pfizer · NCT06760637

This study is testing a new treatment combining PF-07220060 with letrozole to see if it helps adults with advanced breast cancer feel better compared to standard treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1020 (estimated)
Ages18 Years and up
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionsradiation
Locations518 sites (Birmingham, Alabama and 517 other locations)
Trial IDNCT06760637 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of PF-07220060 in combination with letrozole in adults with HR-positive, HER2-negative breast cancer that has not been previously treated for advanced or metastatic disease. Participants will be randomly assigned to receive either the experimental treatment or an approved standard treatment alongside letrozole. The study aims to monitor the participants' responses and side effects during regular clinic visits. The goal is to determine if the new treatment offers any advantages over existing therapies.

Who should consider this trial

Good fit: Ideal candidates are adults with HR-positive, HER2-negative breast cancer that is locally advanced or metastatic and who have not undergone any prior systemic anticancer treatment.

Not a fit: Patients with a history of central nervous system metastases or those who have received prior systemic anticancer therapy for their advanced disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced breast cancer who have not received prior systemic therapy.

How similar studies have performed: Other studies have shown success with similar approaches in treating HR-positive, HER2-negative breast cancer, indicating that this strategy is promising.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 517 other locations

+468 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast CancerLocally advanced or metastatic breast cancerEstrogen receptor positive [ER]Progesterone receptor positive [PR]Hormone receptor positive [HR]Human epidermal growth factor receptor 2 negative [HER2]ER/HER2PR/HER2
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.