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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 · View on ClinicalTrials.gov ↗
Study 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 ef
Conditions Studied
Interventions
- DRUG Exemestane
- DRUG Everolimus
- DRUG Fulvestrant
- DRUG PF-07248144
Study Locations (20)
Arizona
- Ironwood Cancer & Research Centers — Chandler
- Ironwood Cancer & Research Centers — Gilbert
- Ironwood Cancer & Research Centers — Glendale
- Ironwood Cancer & Research Centers — Goodyear
- Ironwood Cancer & Research Centers — Mesa
- Ironwood Cancer & Research Centers — Mesa
- Ironwood Cancer & Research Centers — Phoenix
- Ironwood Cancer & Research Centers — Scottsdale
California
- Los Angeles Cancer Network - Anaheim — Anaheim
- Los Angeles Cancer Network - Fountain Valley — Fountain Valley
- Los Angeles Cancer Network - (Admin Only / Central IDS) - No Patients — Glendale
- Los Angeles Hematology Oncology Medical Group — Los Angeles
- Los Angeles Cancer Network - Van Nuys — Los Angeles
- Clinical and Translational Research Unit (CTRU) — Palo Alto
- Stanford Cancer Center — Palo Alto
- Stanford Women's Cancer Center — Palo Alto
Connecticut
- Smilow Cancer Hospital - Derby — Derby
- Smilow Cancer Hospital - Fairfield — Fairfield
- Smilow Cancer Hospital - Glastonbury — Glastonbury
Arkansas
- Highlands Oncology Group, PA — Springdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2025-08-05 |
| Est. Completion | 2030-11-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07062965
The ClinicalTrials.gov registry entry for NCT07062965 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions — of which Exemestane is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07062965 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Arizona, California, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07062965 about?
NCT07062965 is a clinical study titled "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.". 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...
What is the current status of trial NCT07062965?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2025-08-05. Estimated completion is 2030-11-04.
What conditions does trial NCT07062965 study?
This clinical trial studies the following conditions: Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07062965?
The interventions under investigation include: Exemestane (DRUG), Everolimus (DRUG), Fulvestrant (DRUG), PF-07248144 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07062965?
This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07062965 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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