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Study of PF-07220060 with Letrozole for HR-positive HER2-negative Breast Cancer

This study is for adults with advanced or metastatic breast cancer that is HR-positive (meaning the cancer cells need hormones to grow) and HER2-negative (meaning the cells have low or no HER2 protein). You would be eligible if you haven't received prior treatment for your advanced breast cancer. The study is comparing a new drug, PF-07220060, given with letrozole, against standard treatments like palbociclib, ribociclib, or abemaciclib, also given with letrozole. Researchers want to see how safe and effective PF-07220060 is. Success will be measured by how long you live without your cancer getting worse (Progression Free Survival). The study aims to enroll 1035 participants, but its current status is unclear.

Study design
This interventional study aims to enroll 1035 participants. It compares a new drug combination to approved treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the date of randomization until disease progression or death, for up to approximately 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
Pfizer
~1,035 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:PF-07220060letrozoleabemaciclibpalbociclibribociclib

At a glance

Recruiting sites
0 of 463 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS) by BICR
Measured over From the date of randomization until disease progression or death due to any cause (up to approximately 4 years)

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

463 sites across 173 states
California62
Illinois21
Texas18
Utah11
Seoul-teukbyeolsi [seoul]10
Turkey (Türkiye)10
Arkansas9
Missouri9

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Progression Free Survival (PFS) by BICRFrom 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