Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Confirmed diagnosis of HR-positive HER2-negative breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent. - Prior CDK4/6 inhibitor therapy in combination with endocrine therapy in advance metastatic setting or in adjuvant setting with documented progression during or within 12 months after the last dose of CDK4/6i. - Participants are eligible if they previously received CDK4/6i or ET as a monotherapy, or in combination for rechallenge therapy in the advance or metastatic setting; have received prior therapy targeting estrogen receptor 1 (ESR1) or breast cancer gene (BRCA)1/2. - Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.

Exclusion Criteria

  • Documented detectable PIK3CA/AKT1/PTEN alterations in tissue - Received greater than two prior lines of systemic therapy in the advance or metastatic setting - Had received any prior chemotherapy, including antibody drug conjugates (ADCs), in advance or metastatic setting. Participants who have previously received chemotherapy in the (neo)adjuvant setting are not excluded from the study. - Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study. - Renal impairment, hepatic dysfunction, or hematologic abnormalities.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Study participants will be randomly assigned into 1 of 2 groups in parallel for the entire duration of the study. The experimental arm will receive PF-07248144 and fulvestrant (Arm A) while the comparator arm will receive everolimus in combination with the study doctor's choice of endocrine therapy (exemestane or fulvestrant; Arm B).
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Arm A: PF-07248144 plus fulvestrant 		PF-07248144 tablet taken by mouth plus fulvestrant taken as a shot into the muscle.
  • Drug: PF-07248144
    KAT6 inhibitor
  • Drug: Fulvestrant
    Endocrine therapy
Active Comparator
Arm B: everolimus plus ET 		Everolimus tablet taken by mouth plus investigator's choice of endocrine therapy of exemestane tablet taken by mouth or fulvestrant taken as a shot into the muscle.
  • Drug: Fulvestrant
    Endocrine therapy
  • Drug: Everolimus
    mTOR inhibitor
  • Drug: Exemestane
    Endocrine therapy

Recruiting Locations

Ironwood Cancer & Research Centers
Chandler, Arizona 85224

Ironwood Cancer & Research Centers
Gilbert, Arizona 85297

Ironwood Cancer & Research Centers
Glendale, Arizona 85306

Ironwood Cancer & Research Centers
Goodyear, Arizona 85395

Ironwood Cancer & Research Centers
Mesa, Arizona 85202

Ironwood Cancer & Research Centers
Mesa, Arizona 85206

Ironwood Cancer & Research Centers
Phoenix, Arizona 85028

Ironwood Cancer & Research Centers
Scottsdale, Arizona 85260

Smilow Cancer Hospital - Derby
Derby, Connecticut 06418

Smilow Cancer Hospital - Fairfield
Fairfield, Connecticut 06824

Smilow Cancer Hospital - Glastonbury
Glastonbury, Connecticut 06033

Smilow Cancer Hospital - Greenwich
Greenwich, Connecticut 06830

Smilow Cancer Hospital - Guilford
Guilford, Connecticut 06437

Smilow Cancer Hospital at Saint Francis
Hartford, Connecticut 06105

Smilow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut 06510

Yale-New Haven Hospital
New Haven, Connecticut 06510

Smilow Cancer Hospital - North Haven
North Haven, Connecticut 06473

Smilow Cancer Hospital - Long Ridge
Stamford, Connecticut 06902

Smilow Cancer Hospital - Torrington
Torrington, Connecticut 06790

Smilow Cancer Hospital - Trumbull
Trumbull, Connecticut 06611

Smilow Cancer Hospital - Waterbury
Waterbury, Connecticut 06708

Smilow Cancer Hospital - Waterford
Waterford, Connecticut 06385

Emory University Hospital Midtown
Atlanta, Georgia 30308

Emory University Hospital
Atlanta, Georgia 30322

Investigational Drug Service Emory University Clinic
Atlanta, Georgia 30322

Winship Cancer Institute
Atlanta, Georgia 30322

Emory Saint Joseph's Hospital
Atlanta, Georgia 30342

Summit Cancer Care, PC
Savannah, Georgia 31405

Summit Cancer Care
Savannah, Georgia 31405

Memorial Hospital.
Shiloh, Illinois 62269

Siteman Cancer Center - Shiloh
Shiloh, Illinois 62269

Mercy Medical Center - Baltimore
Baltimore, Maryland 21202

The Cancer & Hematology Centers
Big Rapids, Michigan 49307

The Cancer & Hematology Centers
Grand Rapids, Michigan 49503

The Cancer & Hematology Centers
Grand Rapids, Michigan 49546

The Cancer & Hematology Centers
Holland, Michigan 49424

The Cancer & Hematology Centers
Norton Shores, Michigan 49444

Siteman Cancer Center - St Peters
City of Saint Peters, Missouri 63376

Siteman Cancer Center - West County
Creve Coeur, Missouri 63141

Siteman Cancer Center - North County
Florissant, Missouri 63031

Siteman Cancer Center
St Louis, Missouri 63108

Barnes-Jewish Hospital
St Louis, Missouri 63110

Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri 63110

Siteman Cancer Center - South County
St Louis, Missouri 63129

Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee 37203

SCRI Oncology Partners
Nashville, Tennessee 37203

Texas Oncology-West Texas
Abilene, Texas 79606

Texas Oncology-Northeast Texas
Allen, Texas 75013

Texas Oncology-West Texas
Amarillo, Texas 79124

Texas Oncology - Central/South Texas
Austin, Texas 78705

Texas Oncology - Central South (Balcones Dr)
Austin, Texas 78731

Texas Oncology - Central South (James Casey)
Austin, Texas 78745

Texas Oncology - Central South (Renfert Way)
Austin, Texas 78758

MD Anderson The Woodlands
Conroe, Texas 77384

Texas Oncology-Northeast Texas
Denison, Texas 75020

Texas Oncology-Northeast Texas
Denton, Texas 76201

Texas Oncology-West Texas
El Paso, Texas 79902

Texas Oncology-West Texas
El Paso, Texas 79915

Texas Oncology-West Texas
El Paso, Texas 79938

Texas Oncology-Northeast Texas
Flower Mound, Texas 75028

Texas Oncology - San Antonio
Fredericksburg, Texas 78624

Texas Oncology - Central South (Pease)
Harlingen, Texas 78550

The University of Texas M. D. Anderson Cancer Center
Houston, Texas 77030

University of Texas MD Anderson Cancer Center
Houston, Texas 77030

MD Anderson West Houston
Houston, Texas 77079

US Oncology Investigational Product Center (IPC)
Irving, Texas 75063

US Oncology Investigational Products Center
Irving, Texas 75063

MD Anderson League City
League City, Texas 77573

Texas Oncology-Northeast Texas
Lewisville, Texas 75056

Texas Oncology-Northeast Texas
Longview, Texas 75601

Texas Oncology - Central South (South 2nd)
McAllen, Texas 78503

Texas Oncology-Northeast Texas
McKinney, Texas 75071

Texas Oncology-West Texas
Midland, Texas 79701

Texas Oncology - San Antonio
New Braunfels, Texas 78130

Texas Oncology-West Texas
Odessa, Texas 79761

Texas Oncology-Northeast Texas
Palestine, Texas 75801

Texas Oncology-Northeast Texas
Paris, Texas 75460

Texas Oncology - San Antonio
San Antonio, Texas 78217

Texas Oncology - San Antonio
San Antonio, Texas 78240

Texas Oncology - San Antonio
San Antonio, Texas 78258

MD Anderson in Sugar Land
Sugar Land, Texas 77478

Texas Oncology-Northeast Texas
Tyler, Texas 75702

Texas Oncology - Central South (Horizon Cir)
Waco, Texas 76712

Texas Oncology - Central South
Waco, Texas 76712

Texas Oncology - Central South (E 6th St)
Weslaco, Texas 78596

Texas Oncology-West Texas
Wichita Falls, Texas 76310

Huntsman Cancer Institute
Salt Lake City, Utah 84112

Bon Secours Cancer Institute at Memorial Regional Medical Center
Mechanicsville, Virginia 23116

Bon Secours St. Francis Medical Center
Midlothian, Virginia 23114

Bon Secours Cancer Institute at St. Mary's Hospital
Richmond, Virginia 23226

Ad-Vance Medical Research
Ponce, Puerto Rico 00717

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.