Palbociclib in Real World Practice

Metastatic Breast Cancer Clinical Trial

Official title:

POLARIS: PALBOCICLIB IN HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER: A PROSPECTIVE MULTICENTER NON-INTERVENTIONAL STUDY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03280303
• Other study ID #: A5481082
• Secondary ID: POLARIS
• Status: Completed
• Start date: January 4, 2017
• Est. completion date: December 22, 2022

Study information

• Verified date: July 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1285
• Est. completion date: December 22, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Age =18 years or older.

2. Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to treatment with curative intent.

3. Documented HR+ (ER+ and/or PR+) tumor based on local standards.

4. Documented HER2- tumor based on local standards.

5. Physician has determined that treatment with palbociclib is indicated.

6. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.

7. Patients who in the opinion of the investigator are willing and able to comply with regular clinic visits as per standard of care practice at the site.

Exclusion Criteria:

1. Patients with a life expectancy of less than 3 months at the time of ABC diagnosis, per the investigator's judgment.

2. Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated research or NIS can be included as long as their standard of care is not altered by the study).

3. Patients on active treatment for malignancies other than ABC at the time of enrollment.

4. Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent.

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Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Other:
• non-interventional

Locations

Country	Name	City	State
Canada	Burnaby Hospital Cancer Centre	Burnaby	British Columbia
Canada	Integrated University Center for Health and Social Services (CIUSSS) of Saguenay-Lac Saint Jean	Chicoutimi	Quebec
Canada	Trillium Health Partners	Mississauga	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
United States	Alabama Oncology	Alabaster	Alabama
United States	Texas Oncology -Allen	Allen	Texas
United States	St. Luke's Hospital - Allentown Campus	Allentown	Pennsylvania
United States	St. Luke's University Health Network - Sacred Heart Hospital	Allentown	Pennsylvania
United States	McFarland Clinic, P.C.	Ames	Iowa
United States	Virginia Cancer Specialists	Arlington	Virginia
United States	Illinois Cancer Specialists	Arlington Heights	Illinois
United States	Asheville Hematology and Oncology	Asheville	North Carolina
United States	Sutter Auburn	Auburn	California
United States	Rocky Mountain Cancer Centers	Aurora	Colorado
United States	Northwest Georgia Oncology Centers, PC	Austell	Georgia
United States	AIS Cancer Center at Adventist Health Bakersfield	Bakersfield	California
United States	Mercy Clinic St. Louis Cancer and Breast Institute	Ballwin	Missouri
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	Mercy Medical Center	Baltimore	Maryland
United States	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana
United States	Our Lady of the Lake Physician Group, Louisiana Hematology Oncology Associates	Baton Rouge	Louisiana
United States	Our Lady of the Lake Regional Medical Center	Baton Rouge	Louisiana
United States	Our Lady of the Lake Regional Medical Center, Oncology 6	Baton Rouge	Louisiana
United States	Alabama Oncology	Bessemer	Alabama
United States	Maryland Oncology and Hematology, PA	Bethesda	Maryland
United States	St. Luke's Hematology Oncology Specialists	Bethlehem	Pennsylvania
United States	St. Luke's Hematology Oncology Specialists	Bethlehem	Pennsylvania
United States	St. Luke's University Heatlh Network	Bethlehem	Pennsylvania
United States	Beverly Hills Cancer Center	Beverly Hills	California
United States	Alabama Oncology	Birmingham	Alabama
United States	Alabama Oncology	Birmingham	Alabama
United States	Alabama Oncology	Birmingham	Alabama
United States	Alabama Oncology	Birmingham	Alabama
United States	Grandview Cancer Center, Alabama Oncology	Birmingham	Alabama
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Boca Raton Regional Hospital/Lynn Cancer Institute	Boca Raton	Florida
United States	Florida Cancer Research Institute	Boca Raton	Florida
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Rocky Mountain Cancer Centers	Boulder	Colorado
United States	Presence St. Mary's Cancer Center	Bourbonnais	Illinois
United States	CareMount Medical	Brewster	New York
United States	West Virginia University Medicine - United Hospital Center	Bridgeport	West Virginia
United States	St. Louis Cancer Care, LLP	Bridgeton	Missouri
United States	Wellmont Bristol Regional Medical Center	Bristol	Tennessee
United States	Wellmont Medical Associates Oncology and Hematology	Bristol	Tennessee
United States	Wellmont Medical Associates Oncology and Hematology	Bristol	Virginia
United States	Providence Health and Services Southern California	Burbank	California
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Hematology Oncology Associates, Inc.	Canton	Ohio
United States	Mercy Medical Center	Canton	Ohio
United States	Northwest Georgia Oncology Centers, PC	Carrollton	Georgia
United States	Northwest Georgia Oncology Centers, PC	Cartersville	Georgia
United States	Oncology Associates at Mercy Medical Center	Cedar Rapids	Iowa
United States	Charleston Cancer Center	Charleston	South Carolina
United States	University of Tennessee/Erlanger Oncology and Hematology	Chattanooga	Tennessee
United States	Cancer Specialists of Tidewater/Riverside Cancer Infusion Center	Chesapeake	Virginia
United States	St. Louis Cancer Care, LLP	Chesterfield	Missouri
United States	The Office of Frederick P. Smith, MD	Chevy Chase	Maryland
United States	Presence Saint Joseph Hospital	Chicago	Illinois
United States	Enloe Regional Cancer Center	Chico	California
United States	Johnston Health Services Corporation - Clayton	Clayton	North Carolina
United States	Maryland Oncology Hematology, P.A.	Clinton	Maryland
United States	Haywood Infusion Center	Clyde	North Carolina
United States	Rocky Mountain Cancer Centers	Colorado Springs	Colorado
United States	Boone Hospital Center	Columbia	Missouri
United States	Maryland Oncology Hematology, P.A.	Columbia	Maryland
United States	Missouri Cancer Associates	Columbia	Missouri
United States	Mid Ohio Oncology/Hematology, Inc. dba The Mark H. Zangmeister Center	Columbus	Ohio
United States	John Muir Clinical Research Center	Concord	California
United States	John Muir Medical Center, Concord Campus	Concord	California
United States	Mount Diablo Solano Oncology Group	Concord	California
United States	Minnesota Oncology Hematology, PA	Coon Rapids	Minnesota
United States	Pontchartrain Cancer Center	Covington	Louisiana
United States	North Shore Oncology Hematology Associates	Crystal Lake	Illinois
United States	North Shore Oncology-Hematology Associates	Crystal Lake	Illinois
United States	Texas Oncology	Dallas	Texas
United States	Western Connecticut Health Network	Danbury	Connecticut
United States	Texas Oncology-Denton South	Denton	Texas
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	Northwest Georgia Oncology Centers, PC	Douglasville	Georgia
United States	Tri-County Hematology and Oncology Associates, Inc.	Dover	Ohio
United States	Gwinnett Hospital System, Inc.	Duluth	Georgia
United States	Gwinnett Hospital System, Inc. The Center for Cancer Care	Duluth	Georgia
United States	Greenville Health System	Easley	South Carolina
United States	New York Cancer and Blood Specialists	East Setauket	New York
United States	St. Luke's University Heatlh Network	Easton	Pennsylvania
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Fairview Southdale Medical Oncology Clinic	Edina	Minnesota
United States	Texas Oncology-El Paso Cancer Treatment Center	El Paso	Texas
United States	Willamette Valley Cancer Institute and Research Center	Eugene	Oregon
United States	Presence Infusion Care - Evanston	Evanston	Illinois
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	Cape Fear Valley Health System	Fayetteville	North Carolina
United States	Cape Fear Valley Health System	Fayetteville	North Carolina
United States	Augusta Health Cancer Center	Fishersville	Virginia
United States	Cancer Specialists of North Florida	Fleming Island	Florida
United States	Southeast Florida Hematology-Oncology Group, PA	Fort Lauderdale	Florida
United States	Texas Oncology	Fort Worth	Texas
United States	Texas Oncology - Fort Worth Cancer Center	Fort Worth	Texas
United States	Texas Oncology - Southwest Fort Worth	Fort Worth	Texas
United States	Maryland Oncology Hematology, P.A.	Frederick	Maryland
United States	Virginia Cancer Specialists	Gainesville	Virginia
United States	Tidelands Waccamaw Oncology/Georgrtown Hospital System	Georgetown	South Carolina
United States	Global Cancer Research Institute, Inc.	Gilroy	California
United States	Peninsula Cancer Institute/Riverside Cancer Infusion Center	Gloucester	Virginia
United States	Colorado West Healthcare System, dba Community Hospital	Grand Junction	Colorado
United States	Colorado West Healthcare System, dba Grand Valley Oncology	Grand Junction	Colorado
United States	East Carolina University Brody School of Medicine	Greenville	North Carolina
United States	Greenville Health System	Greenville	South Carolina
United States	Greenville Health System	Greenville	South Carolina
United States	Greenville Health System	Greer	South Carolina
United States	Great Lakes Cancer Management	Grosse Pointe Woods	Michigan
United States	Hackensack University Medical Center, John Theurer Cancer Center	Hackensack	New Jersey
United States	Antietam Oncology and Hematology Group, PC	Haggerstown	Maryland
United States	Pontchartrain Cancer Center	Hammond	Louisiana
United States	Pinnacle Health Cancer Center	Harrisburg	Pennsylvania
United States	Pinnacle Health Cancer Institute	Harrisburg	Pennsylvania
United States	DLP Maria Parham Medical Center	Henderson	North Carolina
United States	Advent Health - Hendersonville	Hendersonville	North Carolina
United States	University of North Carolina Regional Physicians Hematology Oncology	High Point	North Carolina
United States	MD Anderson Cancer Center	Houston	Texas
United States	Texas Oncology	Houston	Texas
United States	Huntington Internal Medicine Group	Huntington	West Virginia
United States	St. Mary's Medical Center	Huntington	West Virginia
United States	Cancer Specialists LLC	Jacksonville	Florida
United States	Cancer Specialists of North Florida	Jacksonville	Florida
United States	Cancer Specialists of North Florida	Jacksonville	Florida
United States	Cancer Specialists of North Florida	Jacksonville	Florida
United States	Cancer Specialists of North Florida	Jacksonville	Florida
United States	Cancer Specialists of North Florida	Jacksonville	Florida
United States	University of Florida Health	Jacksonville	Florida
United States	Wellmont Medical Associates Oncology and Hematology	Johnson City	Tennessee
United States	Joliet Oncology-Hematology Associates, LTD	Joliet	Illinois
United States	St. Luke's Cancer Institute	Kansas City	Missouri
United States	St. Luke's Cancer Institute - East	Kansas City	Missouri
United States	Novant Health Oncology Specialists	Kernersville	North Carolina
United States	Wellmont Cancer Institute	Kingsport	Tennessee
United States	Wellmont Holston Valley Medical Center	Kingsport	Tennessee
United States	Breastlink Medical Group, Inc.	Laguna Hills	California
United States	Watson Clinic	Lakeland	Florida
United States	Rocky Mountain Cancer Centers	Lakewood	Colorado
United States	Carolina Blood and Cancer Care Associates, PA	Lancaster	South Carolina
United States	Lancaster Cancer Center	Lancaster	Pennsylvania
United States	Duke Cancer Network	Laurinburg	North Carolina
United States	Gwinnett Hospital System Inc.	Lawrenceville	Georgia
United States	Gwinnett Hospital System, Inc. The Center for Cancer Care	Lawrenceville	Georgia
United States	Virginia Cancer Specialists	Leesburg	Virginia
United States	St. Luke's Cancer Institute - Liberty	Liberty	Missouri
United States	Advocate Condell Medical Center	Libertyville	Illinois
United States	North Shore Oncology-Hematology Associates	Libertyville	Illinois
United States	Nebraska Hematology/Oncology, PC	Lincoln	Nebraska
United States	Central Arkansas Radiation Therapy Institute	Little Rock	Arkansas
United States	Rocky Mountain Cancer Centers	Littleton	Colorado
United States	Rocky Mountain Cancer Centers	Lone Tree	Colorado
United States	Rocky Mountain Cancer Centers	Longmont	Colorado
United States	University Medical Center Health System, Southwest Cancer Center	Lubbock	Texas
United States	Southeastern Regional Medical Center	Lumberton	North Carolina
United States	University of Minnesota Health Maple Grove Clinics	Maple Grove	Minnesota
United States	Northwest Georgia Oncology Centers, PC	Marietta	Georgia
United States	Cancer Center at West Jefferson Medical Center, New Orleans Physician Services, Inc.	Marrero	Louisiana
United States	Crescent City Research Consortium, LLC	Marrero	Louisiana
United States	Tri-County Hematology and Oncology Associates, Inc.	Massilon	Ohio
United States	Texas Oncology	McAllen	Texas
United States	Texas Oncology - McKinney	McKinney	Texas
United States	Ortenzio Cancer Center at Pinnacle Health	Mechanicsburg	Pennsylvania
United States	Bon Secours Memorial Regional Medical Center, Inc.	Mechanicsville	Virginia
United States	Bon Secours Richmond Community Hospital dba Oncology Associates at Memorial Regional Medical Center	Mechanicsville	Virginia
United States	Texas Oncology	Mesquite	Texas
United States	East Jefferson General Hospital	Metairie	Louisiana
United States	Baptist Health Medical Group Oncology, LLC	Miami	Florida
United States	Baptist Health Miami Cancer Institute	Miami	Florida
United States	Miami Cancer Institute at Baptist Health, Inc.	Miami	Florida
United States	Cancer Specialists of North Florida - St. Vincent's Clay	Middleburg	Florida
United States	Bon Secours Cancer Institute @ St. Francis Medical Center	Midlothian	Virginia
United States	Bon Secours Richmond Community Hospital dba Oncology Associates at St. Francis Medical Center	Midlothian	Virginia
United States	Bon Secours St. Francis Medical Center, Inc.	Midlothian	Virginia
United States	Minnesota Oncology Hematology, PA	Minneapolis	Minnesota
United States	West Virginia University, Mary Babb Randolph Cancer Center	Morgantown	West Virginia
United States	Joliet Oncology-Hematology Associates, LTD	Morris	Illinois
United States	Novant Health Oncology Specialists	Mount Airy	North Carolina
United States	CareMount Medical	Mount Kisco	New York
United States	Northern Westchester Hospital	Mount Kisco	New York
United States	Tidelands Waccamaw Oncology/Georgrtown Hospital System	Murrells Inlet	South Carolina
United States	Tidelands Waccamaw Oncology/Georgrtown Hospital System	Myrtle Beach	South Carolina
United States	Riverside Shore Cancer Center	Nassawadox	Virginia
United States	Joliet Oncology-Hematology Associates, LTD	New Lenox	Illinois
United States	Western Connecticut Health Network	New Milford	Connecticut
United States	Touro Infirmary	New Orleans	Louisiana
United States	Oncology Hematology Associates of Southwest Indiana	Newburgh	Indiana
United States	Breastlink Medical Group, Inc.	Newport Beach	California
United States	Peninsula Cancer Institute/Riverside Cancer Infusion Center	Newport News	Virginia
United States	New England Hematology Oncology/Massachusetts General Cancer Center at Newton Wellesley Hospital	Newton	Massachusetts
United States	Mid Illinois Hematology And Oncology Associates, Limited	Normal	Illinois
United States	University of Kansas Cancer Center	North Kansas City	Missouri
United States	Novant Health Oncology Specialists	North Wilkesboro	North Carolina
United States	Southwest Virginia Regional Cancer Center	Norton	Virginia
United States	Western Connecticut Health Network	Norwalk	Connecticut
United States	Breastlink Medical Group, Inc.	Orange	California
United States	The Valley Hospital	Paramus	New Jersey
United States	Texas Oncology-Paris	Paris	Texas
United States	Rocky Mountain Cancer Centers	Parker	Colorado
United States	Camden Clark Medical Center	Parkersburg	West Virginia
United States	New York Cancer and Blood Specialists	Patchogue	New York
United States	Millennium Oncology Research Clinic/Hematology and Oncology Private Practice	Pembroke	Florida
United States	Mercy Health Perrysburg Cancer Center	Perrysburg	Ohio
United States	St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare	Petaluma	California
United States	St. Luke's University Heatlh Network - Warren Hospital	Phillipsburg	New Jersey
United States	Texas Oncology	Plano	Texas
United States	Baptist Health Miami Cancer Institute	Plantation	Florida
United States	Florida Cancer Research Institute	Plantation	Florida
United States	Diablo Valley Oncology Hematology Medical Group	Pleasant Hill	California
United States	Epic Care	Pleasant Hill	California
United States	New York Cancer and Blood Specialists	Port Jefferson Station	New York
United States	Northwest Cancer Specialists, PC	Portland	Oregon
United States	Northwest Cancer Specialists, PC	Portland	Oregon
United States	Delta Hematology/Oncology Associates	Portsmouth	Virginia
United States	Portsmouth Regional Hospital	Portsmouth	New Hampshire
United States	Rocky Mountain Cancer Centers	Pueblo	Colorado
United States	Quincy Medical Group	Quincy	Illinois
United States	Bon Secours Richmond Community Hospital dba Oncologists Associates at St. Mary's Hospital	Richmond	Virginia
United States	Bon Secours St. Mary's Hospital, Inc.	Richmond	Virginia
United States	New York Cancer and Blood Specialists	Riverhead	New York
United States	Carolina Blood and Cancer Care Associates, PA	Rock Hill	South Carolina
United States	Maryland Oncology Hematology, P.A.	Rockville	Maryland
United States	Sutter Roseville Medical Center	Roseville	California
United States	Northwest Georgia Oncology Centers, PC	Roswell	Georgia
United States	Sutter Institute for Medical Research	Sacramento	California
United States	Cancer Specialists of North Florida	Saint Augustine	Florida
United States	St. Helena Hospital	Saint Helena	California
United States	Heartland Regional Medical Center/dba Cancer Care St. Joseph Mosaic Life Care	Saint Joseph	Missouri
United States	Mercy Clinic St. Louis Cancer and Breast Institute	Saint Louis	Missouri
United States	Mercy Hospital St. Louis	Saint Louis	Missouri
United States	Mercy Research - Mercy Heart Hospital St. Louis	Saint Louis	Missouri
United States	SSM Health St. Louis University Hospital	Saint Louis	Missouri
United States	St. Louis Cancer Care, LLP	Saint Louis	Missouri
United States	St. Louis University Cancer Center	Saint Louis	Missouri
United States	Health Partners Institute	Saint Louis Park	Minnesota
United States	Metro-Minnesota Community Oncology Research Consortium	Saint Louis Park	Minnesota
United States	Park Nicollet Frauenshuh Cancer Center	Saint Louis Park	Minnesota
United States	Minnesota Oncology Hematology, PA	Saint Paul	Minnesota
United States	Regions Hospital	Saint Paul	Minnesota
United States	Regions Hospital Cancer Care Center	Saint Paul	Minnesota
United States	Salinas Valley Medical Clinic Cancer Care	Salinas	California
United States	Salinas Valley Memorial Healthcare System	Salinas	California
United States	Texas Oncology	San Antonio	Texas
United States	Texas Oncology-San Antonio Downtown	San Antonio	Texas
United States	Texas Oncology-San Antonio Stone Oak	San Antonio	Texas
United States	Santa Clara Valley Medical Center	San Jose	California
United States	Cancer Research Collaboration/Breastlink Medical Group, Inc.	Santa Ana	California
United States	Ridley Tree Cancer Center	Santa Barbara	California
United States	SANSUM Clinic	Santa Barbara	California
United States	St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare	Santa Rosa	California
United States	Candler Medical Oncology Practice (CMOP)	Savannah	Georgia
United States	Candler Medical Oncology Practice (CMOP)/Summit Cancer Care	Savannah	Georgia
United States	Summit Cancer Care Research	Savannah	Georgia
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Greenville Health System	Seneca	South Carolina
United States	Maryland Oncology Hematology, P.A.	Silver Spring	Maryland
United States	Maryland Oncology Hematology, P.A.	Silver Spring	Maryland
United States	Orchard Healthcare Research Inc.	Skokie	Illinois
United States	Presence Infusion Care - Skokie	Skokie	Illinois
United States	Johnston Health Services Corporation - Smithfield	Smithfield	North Carolina
United States	New York Cancer and Blood Specialists	Smithtown	New York
United States	Gwinnett Hospital System, Inc. The Center for Cancer Care	Snellville	Georgia
United States	Sansum Clinic	Solvang	California
United States	Greenville Health System	Spartanburg	South Carolina
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Willamette Valley Cancer Institute and Research Center	Springfield	Oregon
United States	Novant Health Oncology Specialists	Statesville	North Carolina
United States	Lakeview Hospital	Stillwater	Minnesota
United States	St. Joseph's Medical Center	Stockton	California
United States	Stockton Hematology Oncology Medical Group	Stockton	California
United States	Central Arkansas Radiation Therapy Institute	Stuttgart	Arkansas
United States	Cancer Specialists of Tidewater/Riverside Cancer Infusion Center	Suffolk	Virginia
United States	M. Francisco Gonzalez, MD, PA	Sumter	South Carolina
United States	Baptist Health Urgent Care Sawgrass	Sunrise	Florida
United States	Novant Health Oncology Specialists	Thomasville	North Carolina
United States	Rocky Mountain Cancer Centers	Thornton	Colorado
United States	Mercy Health Cancer Center	Toledo	Ohio
United States	Mercy Health St. Vincent Medical Center	Toledo	Ohio
United States	Stormont Vail Cotton O'Neill Cancer Center	Topeka	Kansas
United States	Stormont Vail Regional Health Center	Topeka	Kansas
United States	University of Maryland St. Joseph Medical Center	Towson	Maryland
United States	Munson Medical Center	Traverse City	Michigan
United States	North Mississippi Medical Center, Inc., Hematology and Oncology Research	Tupelo	Mississippi
United States	Texas Oncology	Tyler	Texas
United States	Cancer Treatment Center of Vacaville	Vacaville	California
United States	Solano Hematology Oncology	Vallejo	California
United States	Northwest Cancer Specialists, PC	Vancouver	Washington
United States	Cancer Specialists of Tidewater/Riverside Cancer Infusion Center	Virginia Beach	Virginia
United States	Contra Costa Oncology	Walnut Creek	California
United States	John Muir Medical Center, Walnut Creek Camous	Walnut Creek	California
United States	Great Lakes Cancer Management	Warren	Michigan
United States	Mercy Health Youngstown dba St Joseph Warren Hospital	Warren	Ohio
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	University of Kansas Cancer Center	Westwood	Kansas
United States	White Plains Hospital	White Plains	New York
United States	Peninsula Cancer Institute/Riverside Cancer Infusion Center	Williamsburg	Virginia
United States	Rice Memorial Hospital	Willmar	Minnesota
United States	Novant Health Oncology Specialists	Winston-Salem	North Carolina
United States	Minnesota Oncology Hematology, PA	Woodbury	Minnesota
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts
United States	Mercy Health Youngstown dba St. Elizabeth Youngstown Hospital	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcome	Progression free survival: the time from the start date of palbociclib to the date of the progression of disease or death according to investigator's assessment	Reporting will be based on sample size and follow up time through 2022.
Primary	Patient quality of life, as measured by EORTC QLQ-C30	EORTC QLQ-C30 is used to assess changes in quality of life for patients undergoing treatment for cancer. It is a 30-item questionnaire assessing other cancer-related symptoms, with responses based on recall during the past week.	Reporting will be based on sample size and follow up time through 2022.
Primary	Geriatric Assessments in patients equal to or greater than 70 years of age at enrollment, as assessed by G8 Screening Tool	The G8 Screening Tool is a physician-assessed tool to identify geriatric cancer patients for comprehensive geriatric assessment to evaluate an older person's functional ability, physical health, cognition and mental health, and socioenvironmental circumstances.	Reporting will be based on sample size and follow up time through 2022.
Primary	Geriatric Assessments in patients equal to or greater than 70 years of age at enrollment, as assessed by Activities of Daily Living	Activities of daily living assesses patient basic self-care skills to maintain independence in home (bathing, dressing toileting, feeding oneself, maintain continent, transferring from bed/chair).	Reporting will be based on sample size and follow up time through 2022.
Primary	Biomarker Assessment	Exploratory research question for investigating potential mechanism of response and resistance to palbociclib treatment, through genomic analyses in the blood samples collected at standard of care intervals.	Reporting will be based on sample size and follow up time through 2022.

External Links

•   To obtain contact information for a study center near you, click here.