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. (NCT07062965)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Ironwood Cancer & Research Centers — Chandler, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (202 Sites)
Showing the first 25 of 202 sites.
- Ironwood Cancer & Research Centers — Chandler, Arizona
- Ironwood Cancer & Research Centers — Gilbert, Arizona
- Ironwood Cancer & Research Centers — Glendale, Arizona
- Ironwood Cancer & Research Centers — Goodyear, Arizona
- Ironwood Cancer & Research Centers — Mesa, Arizona
- Ironwood Cancer & Research Centers — Mesa, Arizona
- Ironwood Cancer & Research Centers — Phoenix, Arizona
- Ironwood Cancer & Research Centers — Scottsdale, Arizona
- Ventura County Hematology Oncology Specialists — Camarillo, California
- Los Angeles Cancer Network - (Admin Only / Central IDS) - No Patients — Glendale, California
- Los Angeles Cancer Network - Good Samaritan — Los Angeles, California
- Los Angeles Hematology Oncology Medical Group — Los Angeles, California
- Rolling Oaks Radiology - Oxnard — Oxnard, California
- Ventura County Hematology Oncology Specialists — Oxnard, California
- Dr. Manoj Khatore, MD, FACC (Cardiology Practice) — Oxnard, California
- Ventura County Hematology Oncology Specialists — Ventura, California
- Rocky Mountain Cancer Centers LLP — Aurora, Colorado
- Rocky Mountain Cancer Centers LLP — Boulder, Colorado
- Rocky Mountain Cancer Centers LLP — Centennial, Colorado
- Rocky Mountain Cancer Centers LLP — Colorado Springs, Colorado
- Rocky Mountain Cancer Centers LLP — Colorado Springs, Colorado
- Rocky Mountain Cancer Centers LLP — Denver, Colorado
- Rocky Mountain Cancer Centers LLP — Englewood, Colorado
- Rocky Mountain Cancer Centers LLP — Lakewood, Colorado
- Rocky Mountain Cancer Centers LLP — Littleton, Colorado
📞 Contact the Study Coordinator
Phone: (800) 718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.