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RECRUITING

NCT07062965

PHASE3

A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.

Sponsor: Pfizer

View on ClinicalTrials.gov

Summary

The purpose of this study is to learn about the safety and effects of the study medicine PF-07248144 when given along with fulvestrant for the possible treatment of HR-positive, HER2-negative advanced or metastatic breast cancer. HR-positive breast cancer cells have proteins on their surface called receptors that bind to hormones like estrogen and progesterone (female sex hormones). These hormones can promote the growth of cancer cells. HER2-negative describes cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2-negative may grow more slowly and are less likely to recur (come back) or spread to other parts of the body than cancer cells that have a large amount of HER2 on their surface. Advanced cancer is a term that is often used to describe cancer that is unlikely to be cured. Metastatic cancer is the type where the cancer cells spread from one part of the body to another. This study is seeking for participants whose breast cancer has gotten worsen after receiving cyclin dependent kinase (CDK) 4/6 inhibitor-based therapy. Half of participants in this study will receive their usual study treatment, everolimus with endocrine therapy (either exemestane or fulvestrant) for HR-positive/HER2-negative advanced or metastatic breast cancer (A/mBC). The study doctor will discuss which hormone therapy is right for the participant before treatment begins. PF-07248144 is a tablet that will be taken by mouth at home every day in a 28-day cycle. Fulvestrant will be given as two injections (one injection in the buttock) at visits to the study clinic. Everolimus and exemestane are also tablets and will be taken by mouth at home every day in a 28-day cycle. The study will compare the experiences of people receiving PF-07248144 in combination with fulvestrant to those of the people who do not. This will help see if PF-07248144 in combination with fulvestrant is safe and effective.

Official title: An Interventional, Open-Label, Randomized, Multicenter, Phase 3 Study of PF-07248144 Plus Fulvestrant Compared to Investigator's Choice of Therapy in Adult Participants With Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4/6 Inhibitor-based Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2025-08-05

Completion Date

2030-11-04

Last Updated

2026-10-19

Healthy Volunteers

Conditions

Breast Cancer

Interventions

DRUG

PF-07248144

KAT6 inhibitor

DRUG

Fulvestrant

Endocrine therapy

DRUG

Everolimus

mTOR inhibitor

DRUG

Exemestane

Endocrine therapy

Locations (433)

Alaska Oncology and Hematology, LLC

Anchorage, Alaska, United States

Ironwood Cancer & Research Centers

Chandler, Arizona, United States

Banner Gateway Medical Center

Gilbert, Arizona, United States

Banner MD Anderson Cancer Center

Gilbert, 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

Highlands Oncology Group, PA

Fayetteville, Arkansas, United States

Highlands Oncology Group, PA

Rogers, Arkansas, United States

Highlands Oncology Group, PA

Springdale, Arkansas, United States

Oncura Health - Anaheim

Anaheim, California, United States

Ventura County Hematology Oncology Specialists

Camarillo, California, United States

Oncura Health - Fountain Valley

Fountain Valley, California, United States

Oncura Health - Corporate (Central IDS & Regulatory Only)

Glendale, California, United States

Oncura Health - Good Samaritan

Los Angeles, California, United States

Dr. Karandeep Singh MD

Oxnard, California, United States

Rolling Oaks Radiology - Oxnard

Oxnard, California, United States

Ventura County Hematology Oncology Specialists

Oxnard, California, United States

Rolling Oaks Radiology North Solar

Oxnard, California, United States

Clinical and Translational Research Unit (CTRU)

Palo Alto, California, United States

Stanford Cancer Center

Palo Alto, California, United States

Stanford Women's Cancer Center

Palo Alto, California, United States

Sansum Clinic

Santa Barbara, California, United States

Sansum Clinic

Solvang, California, United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, United States

Torrance Memorial Physician Network - Cancer Care

Torrance, California, United States

Torrance Memorial Physician Network-Cancer Care

Torrance, California, United States

Harbor-UCLA Medical Center

Torrance, California, United States

Oncura Health - Valley Presbyterian

Van Nuys, California, United States

Ventura County Hematology Oncology Specialists

Ventura, California, United States