Status:
RECRUITING
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
Lead Sponsor:
Pfizer
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 wi...
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.
Key Trial Info
Start Date :
January 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 29 2037
Estimated Enrollment :
1020 Patients enrolled
Trial Details
Trial ID
NCT06760637
Start Date
January 6 2025
End Date
December 29 2037
Last Update
March 2 2026
Active Locations (518)
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1
The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, United States, 35233
2
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
3
University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States, 35249
4
Ironwood Cancer & Research Centers
Chandler, Arizona, United States, 85224