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.
Public ClinicalTrials.gov record NCT07062965. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07062965
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 400 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 4, 2025
- Primary completion
- Jul 21, 2027
- Completion
- Nov 3, 2030
- Last update posted
- May 5, 2026
2025 – 2030
United States locations
- U.S. sites
- 102
- U.S. states
- 18
- U.S. cities
- 88
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ironwood Cancer & Research Centers | Chandler | Arizona | 85224 | Recruiting |
| Ironwood Cancer & Research Centers | Gilbert | Arizona | 85297 | Recruiting |
| Ironwood Cancer & Research Centers | Glendale | Arizona | 85306 | Recruiting |
| Ironwood Cancer & Research Centers | Goodyear | Arizona | 85395 | Recruiting |
| Ironwood Cancer & Research Centers | Mesa | Arizona | 85202 | Recruiting |
| Ironwood Cancer & Research Centers | Mesa | Arizona | 85206 | Recruiting |
| Ironwood Cancer & Research Centers | Phoenix | Arizona | 85028 | Recruiting |
| Ironwood Cancer & Research Centers | Scottsdale | Arizona | 85260 | Recruiting |
| Ventura County Hematology Oncology Specialists | Camarillo | California | 93010 | Not yet recruiting |
| Los Angeles Cancer Network - (Admin Only / Central IDS) - No Patients | Glendale | California | 91204 | Not yet recruiting |
| Los Angeles Cancer Network - Good Samaritan | Los Angeles | California | 90017 | Not yet recruiting |
| Los Angeles Hematology Oncology Medical Group | Los Angeles | California | 90017 | Not yet recruiting |
| Rolling Oaks Radiology - Oxnard | Oxnard | California | 93030 | Not yet recruiting |
| Ventura County Hematology Oncology Specialists | Oxnard | California | 93030 | Not yet recruiting |
| Dr. Manoj Khatore, MD, FACC (Cardiology Practice) | Oxnard | California | 93036 | Not yet recruiting |
| Ventura County Hematology Oncology Specialists | Ventura | California | 93003 | Not yet recruiting |
| Rocky Mountain Cancer Centers LLP | Aurora | Colorado | 80012 | Not yet recruiting |
| Rocky Mountain Cancer Centers LLP | Boulder | Colorado | 80303 | Not yet recruiting |
| Rocky Mountain Cancer Centers LLP | Centennial | Colorado | 80112 | Not yet recruiting |
| Rocky Mountain Cancer Centers LLP | Colorado Springs | Colorado | 80907 | Not yet recruiting |
| Rocky Mountain Cancer Centers LLP | Colorado Springs | Colorado | 80923 | Not yet recruiting |
| Rocky Mountain Cancer Centers LLP | Denver | Colorado | 80220 | Not yet recruiting |
| Rocky Mountain Cancer Centers LLP | Englewood | Colorado | 80113 | Not yet recruiting |
| Rocky Mountain Cancer Centers LLP | Lakewood | Colorado | 80228 | Not yet recruiting |
| Rocky Mountain Cancer Centers LLP | Littleton | Colorado | 80120 | Not yet recruiting |
| Rocky Mountain Cancer Centers LLP | Lone Tree | Colorado | 80124 | Not yet recruiting |
| Rocky Mountain Cancer Centers LLP | Longmont | Colorado | 80504 | Not yet recruiting |
| Rocky Mountain Cancer Centers LLP | Pueblo | Colorado | 81003 | Not yet recruiting |
| Rocky Mountain Cancer Centers LLP | Thornton | Colorado | 80260 | Not yet recruiting |
| Smilow Cancer Hospital - Derby | Derby | Connecticut | 06418 | Recruiting |
| Smilow Cancer Hospital - Fairfield | Fairfield | Connecticut | 06824 | Recruiting |
| Smilow Cancer Hospital - Glastonbury | Glastonbury | Connecticut | 06033 | Recruiting |
| Smilow Cancer Hospital - Greenwich | Greenwich | Connecticut | 06830 | Recruiting |
| Smilow Cancer Hospital - Guilford | Guilford | Connecticut | 06437 | Recruiting |
| Smilow Cancer Hospital at Saint Francis | Hartford | Connecticut | 06105 | Recruiting |
| Smilow Cancer Hospital - Yale New Haven Health | New Haven | Connecticut | 06510 | Recruiting |
| Smilow Cancer Hospital - North Haven | North Haven | Connecticut | 06473 | Recruiting |
| Smilow Cancer Hospital - Long Ridge | Stamford | Connecticut | 06902 | Recruiting |
| Smilow Cancer Hospital - Waterbury | Waterbury | Connecticut | 06708 | Recruiting |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | Not yet recruiting |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | Recruiting |
| Summit Cancer Care, PC | Savannah | Georgia | 31405 | Recruiting |
| Summit Cancer Care | Savannah | Georgia | 31405 | Recruiting |
| Memorial Hospital. | Shiloh | Illinois | 62269 | Recruiting |
| Orchard Healthcare Research Inc. | Skokie | Illinois | 60077 | Not yet recruiting |
| Maryland Oncology Hematology P.A. | Annapolis | Maryland | 21401 | Not yet recruiting |
| Mfsmc-Hjwci | Baltimore | Maryland | 21237 | Not yet recruiting |
| Maryland Oncology Hematology P.A. | Bethesda | Maryland | 20817 | Not yet recruiting |
| Maryland Oncology Hematology P.A. | Columbia | Maryland | 21044 | Not yet recruiting |
| Maryland Oncology Hematology P.A. | Germantown | Maryland | 20876 | Not yet recruiting |
| Maryland Oncology Hematology P.A. | Largo | Maryland | 20774 | Not yet recruiting |
| Maryland Oncology Hematology P.A. | Rockville | Maryland | 20850 | Not yet recruiting |
| Maryland Oncology Hematology P.A. | Silver Spring | Maryland | 20904 | Not yet recruiting |
| The Cancer & Hematology Centers | Holland | Michigan | 49424 | Recruiting |
| Minnesota Oncology Hematology, P.A. | Burnsville | Minnesota | 55337 | Not yet recruiting |
| Minnesota Oncology Hematology, P.A. | Coon Rapids | Minnesota | 55433 | Not yet recruiting |
| Minnesota Oncology Hematology, P.A. | Edina | Minnesota | 55435 | Not yet recruiting |
| Minnesota Oncology Hematology, P.A. | Maple Grove | Minnesota | 55369 | Not yet recruiting |
| Minnesota Oncology Hematology, P.A. | Maplewood | Minnesota | 55109 | Not yet recruiting |
| Minnesota Oncology Hematology, P.A. | Minneapolis | Minnesota | 55404 | Not yet recruiting |
| Minnesota Oncology Hematology, P.A. | Plymouth | Minnesota | 55441 | Not yet recruiting |
| Minnesota Oncology Hematology, P.A. | Woodbury | Minnesota | 55125 | Not yet recruiting |
| Siteman Cancer Center - St Peters | City of Saint Peters | Missouri | 63376 | Recruiting |
| Siteman Cancer Center - North County | Florissant | Missouri | 63031 | Recruiting |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | Not yet recruiting |
| Siteman Cancer Center | St Louis | Missouri | 63108 | Recruiting |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89052 | Not yet recruiting |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89074 | Not yet recruiting |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89128 | Not yet recruiting |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89144 | Not yet recruiting |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89148 | Not yet recruiting |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | Not yet recruiting |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | Not yet recruiting |
| The West Clinic, PLLC dba West Cancer Center | Germantown | Tennessee | 38138 | Not yet recruiting |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | Recruiting |
| Henry-Joyce Cancer Clinic | Nashville | Tennessee | 37232 | Recruiting |
| Texas Oncology-Northeast Texas | Allen | Texas | 75013 | Recruiting |
| Texas Oncology - Central South (Balcones Dr) | Austin | Texas | 78731 | Recruiting |
| Texas Oncology - Central South (James Casey) | Austin | Texas | 78745 | Recruiting |
| Texas Oncology-Northeast Texas | Denison | Texas | 75020 | Recruiting |
| Texas Oncology-Northeast Texas | Denton | Texas | 76201 | Recruiting |
| Texas Oncology-Northeast Texas | Flower Mound | Texas | 75028 | Recruiting |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
| MD Anderson West Houston | Houston | Texas | 77079 | Recruiting |
| US Oncology Investigational Product Center (IPC) | Irving | Texas | 75063 | Recruiting |
| US Oncology Investigational Products Center | Irving | Texas | 75063 | Recruiting |
| MD Anderson League City | League City | Texas | 77573 | Recruiting |
| Texas Oncology-Northeast Texas | Lewisville | Texas | 75056 | Recruiting |
| Texas Oncology-Northeast Texas | Longview | Texas | 75601 | Recruiting |
| Texas Oncology - Central South (South 2nd) | McAllen | Texas | 78503 | Recruiting |
| Texas Oncology-Northeast Texas | McKinney | Texas | 75071 | Recruiting |
| Texas Oncology-Northeast Texas | Palestine | Texas | 75801 | Recruiting |
| Texas Oncology-Northeast Texas | Paris | Texas | 75460 | Recruiting |
| Texas Oncology-Northeast Texas | Tyler | Texas | 75702 | Recruiting |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | Recruiting |
| Virginia Oncology Associates | Chesapeake | Virginia | 23320 | Not yet recruiting |
| Virginia Cancer Specialists | Manassas | Virginia | 20110 | Not yet recruiting |
| Bon Secours Cancer Institute at Memorial Regional Medical Center | Mechanicsville | Virginia | 23116 | Recruiting |
| Virginia Cancer Specialists, PC | Reston | Virginia | 20190 | Not yet recruiting |
| Virginia Oncology Associates | Virginia Beach | Virginia | 23456 | Not yet recruiting |
| Virginia Oncology Associates | Williamsburg | Virginia | 23188 | Not yet recruiting |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 100 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07062965, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 5, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07062965 live on ClinicalTrials.gov.