Palbociclib in Real World Practice

May 20, 2024 updated by: Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Other: non-interventional

Study Type

Observational

Enrollment (Actual)

1285

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- British Columbia
  - Burnaby, British Columbia, Canada, V5G 2X6
    - Burnaby Hospital Cancer Centre
- Ontario
  - Mississauga, Ontario, Canada, L5M 2N1
    - Trillium Health Partners
  - Toronto, Ontario, Canada, M5B 1W8
    - St. Michael's Hospital
- Quebec
  - Chicoutimi, Quebec, Canada, G74 5H6
    - Integrated University Center for Health and Social Services (CIUSSS) of Saguenay-Lac Saint Jean
United States
- Alabama
  - Alabaster, Alabama, United States, 35007
    - Alabama Oncology
  - Bessemer, Alabama, United States, 35022
    - Alabama Oncology
  - Birmingham, Alabama, United States, 35294
    - The University of Alabama at Birmingham
  - Birmingham, Alabama, United States, 35294-3300
    - University of Alabama at Birmingham Comprehensive Cancer Center
  - Birmingham, Alabama, United States, 35209
    - Alabama Oncology
  - Birmingham, Alabama, United States, 35211
    - Alabama Oncology
  - Birmingham, Alabama, United States, 35235
    - Alabama Oncology
  - Birmingham, Alabama, United States, 35205
    - Alabama Oncology
  - Birmingham, Alabama, United States, 35243
    - Grandview Cancer Center, Alabama Oncology
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Central Arkansas Radiation Therapy Institute
  - Stuttgart, Arkansas, United States, 72160
    - Central Arkansas Radiation Therapy Institute
- California
  - Auburn, California, United States, 95602
    - Sutter Auburn
  - Bakersfield, California, United States, 93301
    - AIS Cancer Center at Adventist Health Bakersfield
  - Beverly Hills, California, United States, 90211
    - Beverly Hills Cancer Center
  - Burbank, California, United States, 91505
    - Providence Health and Services Southern California
  - Chico, California, United States, 95926
    - Enloe Regional Cancer Center
  - Concord, California, United States, 94520
    - John Muir Clinical Research Center
  - Concord, California, United States, 94520
    - John Muir Medical Center, Concord Campus
  - Concord, California, United States, 94520
    - Mount Diablo Solano Oncology Group
  - Gilroy, California, United States, 95020
    - Global Cancer Research Institute, Inc.
  - Laguna Hills, California, United States, 92653
    - Breastlink Medical Group, Inc.
  - Newport Beach, California, United States, 92660
    - Breastlink Medical Group, Inc.
  - Orange, California, United States, 92868
    - Breastlink Medical Group, Inc.
  - Petaluma, California, United States, 94954
    - St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
  - Pleasant Hill, California, United States, 94523
    - Diablo Valley Oncology Hematology Medical Group
  - Pleasant Hill, California, United States, 94523
    - Epic Care
  - Roseville, California, United States, 95661
    - Sutter Roseville Medical Center
  - Sacramento, California, United States, 95816
    - Sutter Institute for Medical Research
  - Saint Helena, California, United States, 94574
    - St. Helena Hospital
  - Salinas, California, United States, 93901
    - Salinas Valley Memorial Healthcare System
  - Salinas, California, United States, 93901
    - Salinas Valley Medical Clinic Cancer Care
  - San Jose, California, United States, 95128
    - Santa Clara Valley Medical Center
  - Santa Ana, California, United States, 92705
    - Cancer Research Collaboration/Breastlink Medical Group, Inc.
  - Santa Barbara, California, United States, 93105
    - Sansum Clinic
  - Santa Barbara, California, United States, 93105
    - Ridley Tree Cancer Center
  - Santa Rosa, California, United States, 95403
    - St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
  - Solvang, California, United States, 93463
    - Sansum Clinic
  - Stockton, California, United States, 95204
    - St. Joseph's Medical Center
  - Stockton, California, United States, 95204
    - Stockton Hematology Oncology Medical Group
  - Vacaville, California, United States, 95687
    - Cancer Treatment Center of Vacaville
  - Vallejo, California, United States, 94589
    - Solano Hematology Oncology
  - Walnut Creek, California, United States, 94598
    - Contra Costa Oncology
  - Walnut Creek, California, United States, 94598
    - John Muir Medical Center, Walnut Creek Camous
- Colorado
  - Aurora, Colorado, United States, 80012
    - Rocky Mountain Cancer Centers
  - Boulder, Colorado, United States, 80303
    - Rocky Mountain Cancer Centers
  - Colorado Springs, Colorado, United States, 80907
    - Rocky Mountain Cancer Centers
  - Denver, Colorado, United States, 80218
    - Rocky Mountain Cancer Centers
  - Denver, Colorado, United States, 80220
    - Rocky Mountain Cancer Centers
  - Grand Junction, Colorado, United States, 81505
    - Colorado West Healthcare System, dba Grand Valley Oncology
  - Grand Junction, Colorado, United States, 81505
    - Colorado West Healthcare System, dba Community Hospital
  - Lakewood, Colorado, United States, 80228
    - Rocky Mountain Cancer Centers
  - Littleton, Colorado, United States, 80120
    - Rocky Mountain Cancer Centers
  - Lone Tree, Colorado, United States, 80124
    - Rocky Mountain Cancer Centers
  - Longmont, Colorado, United States, 80501
    - Rocky Mountain Cancer Centers
  - Parker, Colorado, United States, 80138
    - Rocky Mountain Cancer Centers
  - Pueblo, Colorado, United States, 81008
    - Rocky Mountain Cancer Centers
  - Thornton, Colorado, United States, 80260
    - Rocky Mountain Cancer Centers
- Connecticut
  - Danbury, Connecticut, United States, 06810
    - Western Connecticut Health Network
  - New Milford, Connecticut, United States, 06776
    - Western Connecticut Health Network
  - Norwalk, Connecticut, United States, 06856
    - Western Connecticut Health Network
- District of Columbia
  - Washington, District of Columbia, United States, 20037
    - MedStar Washington Hospital Center
- Florida
  - Boca Raton, Florida, United States, 33428
    - Florida Cancer Research Institute
  - Boca Raton, Florida, United States, 33486
    - Boca Raton Regional Hospital/Lynn Cancer Institute
  - Fleming Island, Florida, United States, 32003
    - Cancer Specialists of North Florida
  - Fort Lauderdale, Florida, United States, 33308
    - Southeast Florida Hematology-Oncology Group, PA
  - Jacksonville, Florida, United States, 32256
    - Cancer Specialists of North Florida
  - Jacksonville, Florida, United States, 32204
    - Cancer Specialists of North Florida
  - Jacksonville, Florida, United States, 32207
    - Cancer Specialists of North Florida
  - Jacksonville, Florida, United States, 32258
    - Cancer Specialists of North Florida
  - Jacksonville, Florida, United States, 32209
    - University of Florida Health
  - Jacksonville, Florida, United States, 32250
    - Cancer Specialists of North Florida
  - Jacksonville, Florida, United States, 32256
    - Cancer Specialists LLC
  - Lakeland, Florida, United States, 33805
    - Watson Clinic
  - Miami, Florida, United States, 33176
    - Miami Cancer Institute at Baptist Health, Inc.
  - Miami, Florida, United States, 33176
    - Baptist Health Medical Group Oncology, LLC
  - Miami, Florida, United States, 33176
    - Baptist Health Miami Cancer Institute
  - Middleburg, Florida, United States, 32086
    - Cancer Specialists of North Florida - St. Vincent's Clay
  - Pembroke, Florida, United States, 33024
    - Millennium Oncology Research Clinic/Hematology and Oncology Private Practice
  - Plantation, Florida, United States, 33324
    - Florida Cancer Research Institute
  - Plantation, Florida, United States, 33313
    - Baptist Health Miami Cancer Institute
  - Saint Augustine, Florida, United States, 32086
    - Cancer Specialists of North Florida
  - Sunrise, Florida, United States, 33323
    - Baptist Health Urgent Care Sawgrass
- Georgia
  - Austell, Georgia, United States, 30106
    - Northwest Georgia Oncology Centers, PC
  - Carrollton, Georgia, United States, 30117
    - Northwest Georgia Oncology Centers, PC
  - Cartersville, Georgia, United States, 30121
    - Northwest Georgia Oncology Centers, PC
  - Douglasville, Georgia, United States, 30134
    - Northwest Georgia Oncology Centers, PC
  - Duluth, Georgia, United States, 30096
    - Gwinnett Hospital System, Inc. The Center for Cancer Care
  - Duluth, Georgia, United States, 30096
    - Gwinnett Hospital System, Inc.
  - Lawrenceville, Georgia, United States, 30046
    - Gwinnett Hospital System Inc.
  - Lawrenceville, Georgia, United States, 30046
    - Gwinnett Hospital System, Inc. The Center for Cancer Care
  - Marietta, Georgia, United States, 30060
    - Northwest Georgia Oncology Centers, PC
  - Roswell, Georgia, United States, 30076
    - Northwest Georgia Oncology Centers, PC
  - Savannah, Georgia, United States, 31404
    - Candler Medical Oncology Practice (CMOP)/Summit Cancer Care
  - Savannah, Georgia, United States, 31404
    - Summit Cancer Care Research
  - Savannah, Georgia, United States, 31405
    - Candler Medical Oncology Practice (CMOP)
  - Snellville, Georgia, United States, 30078
    - Gwinnett Hospital System, Inc. The Center for Cancer Care
- Illinois
  - Arlington Heights, Illinois, United States, 60005
    - Illinois Cancer Specialists
  - Bourbonnais, Illinois, United States, 60914
    - Presence St. Mary's Cancer Center
  - Chicago, Illinois, United States, 60657
    - Presence Saint Joseph Hospital
  - Crystal Lake, Illinois, United States, 60014
    - North Shore Oncology-Hematology Associates
  - Crystal Lake, Illinois, United States, 60014
    - North Shore Oncology Hematology Associates
  - Evanston, Illinois, United States, 60202
    - Presence Infusion Care - Evanston
  - Joliet, Illinois, United States, 60435
    - Joliet Oncology-Hematology Associates, LTD
  - Libertyville, Illinois, United States, 60048
    - North Shore Oncology-Hematology Associates
  - Libertyville, Illinois, United States, 60048
    - Advocate Condell Medical Center
  - Morris, Illinois, United States, 60450
    - Joliet Oncology-Hematology Associates, LTD
  - New Lenox, Illinois, United States, 60451
    - Joliet Oncology-Hematology Associates, LTD
  - Normal, Illinois, United States, 61761
    - Mid Illinois Hematology And Oncology Associates, Limited
  - Quincy, Illinois, United States, 62301
    - Quincy Medical Group
  - Skokie, Illinois, United States, 60077
    - Orchard Healthcare Research Inc.
  - Skokie, Illinois, United States, 60077
    - Presence Infusion Care - Skokie
- Indiana
  - Newburgh, Indiana, United States, 47630
    - Oncology Hematology Associates of Southwest Indiana
- Iowa
  - Ames, Iowa, United States, 50010-3014
    - McFarland Clinic, P.C.
  - Cedar Rapids, Iowa, United States, 52403
    - Oncology Associates at Mercy Medical Center
- Kansas
  - Topeka, Kansas, United States, 66604
    - Stormont Vail Regional Health Center
  - Topeka, Kansas, United States, 66606
    - Stormont Vail Cotton O'Neill Cancer Center
  - Westwood, Kansas, United States, 66205
    - University of Kansas Cancer Center
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Mary Bird Perkins Cancer Center
  - Baton Rouge, Louisiana, United States, 70808
    - Our Lady of the Lake Regional Medical Center
  - Baton Rouge, Louisiana, United States, 70809
    - Our Lady of the Lake Physician Group, Louisiana Hematology Oncology Associates
  - Baton Rouge, Louisiana, United States, 70809
    - Our Lady of the Lake Regional Medical Center, Oncology 6
  - Covington, Louisiana, United States, 70433
    - Pontchartrain Cancer Center
  - Hammond, Louisiana, United States, 70403
    - Pontchartrain Cancer Center
  - Marrero, Louisiana, United States, 70072
    - Crescent City Research Consortium, LLC
  - Marrero, Louisiana, United States, 70072
    - Cancer Center at West Jefferson Medical Center, New Orleans Physician Services, Inc.
  - Metairie, Louisiana, United States, 70006
    - East Jefferson General Hospital
  - New Orleans, Louisiana, United States, 70115
    - Touro Infirmary
- Maryland
  - Baltimore, Maryland, United States, 21204
    - Greater Baltimore Medical Center
  - Baltimore, Maryland, United States, 21202
    - Mercy Medical Center
  - Bethesda, Maryland, United States, 20817
    - Maryland Oncology and Hematology, PA
  - Chevy Chase, Maryland, United States, 20815
    - The Office of Frederick P. Smith, MD
  - Clinton, Maryland, United States, 20735
    - Maryland Oncology Hematology, P.A.
  - Columbia, Maryland, United States, 21044
    - Maryland Oncology Hematology, P.A.
  - Frederick, Maryland, United States, 21702
    - Maryland Oncology Hematology, P.A.
  - Haggerstown, Maryland, United States, 21740
    - Antietam Oncology and Hematology Group, PC
  - Rockville, Maryland, United States, 20850
    - Maryland Oncology Hematology, P.A.
  - Silver Spring, Maryland, United States, 20904
    - Maryland Oncology Hematology, P.A.
  - Silver Spring, Maryland, United States, 20902
    - Maryland Oncology Hematology, P.A.
  - Towson, Maryland, United States, 21204
    - University of Maryland St. Joseph Medical Center
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital
  - Newton, Massachusetts, United States, 02462
    - New England Hematology Oncology/Massachusetts General Cancer Center at Newton Wellesley Hospital
  - Worcester, Massachusetts, United States, 01655
    - University of Massachusetts Memorial Medical Center
- Michigan
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Great Lakes Cancer Management
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - Warren, Michigan, United States, 48093
    - Great Lakes Cancer Management
- Minnesota
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Minnesota Oncology Hematology, PA
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Hospital
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Medical Oncology Clinic
  - Maple Grove, Minnesota, United States, 55369
    - University of Minnesota Health Maple Grove Clinics
  - Minneapolis, Minnesota, United States, 55404
    - Minnesota Oncology Hematology, PA
  - Saint Louis Park, Minnesota, United States, 55426
    - Health Partners Institute
  - Saint Louis Park, Minnesota, United States, 55426
    - Park Nicollet Frauenshuh Cancer Center
  - Saint Louis Park, Minnesota, United States, 55416
    - Metro-Minnesota Community Oncology Research Consortium
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital Cancer Care Center
  - Saint Paul, Minnesota, United States, 55102
    - Minnesota Oncology Hematology, PA
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - Willmar, Minnesota, United States, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology, PA
- Mississippi
  - Tupelo, Mississippi, United States, 38801
    - North Mississippi Medical Center, Inc., Hematology and Oncology Research
- Missouri
  - Ballwin, Missouri, United States, 63011
    - Mercy Clinic St. Louis Cancer and Breast Institute
  - Bridgeton, Missouri, United States, 63044
    - St. Louis Cancer Care, LLP
  - Chesterfield, Missouri, United States, 63017
    - St. Louis Cancer Care, LLP
  - Columbia, Missouri, United States, 65201
    - Missouri Cancer Associates
  - Columbia, Missouri, United States, 65201
    - Boone Hospital Center
  - Kansas City, Missouri, United States, 64111
    - St. Luke's Cancer Institute
  - Kansas City, Missouri, United States, 64086
    - St. Luke's Cancer Institute - East
  - Liberty, Missouri, United States, 64068
    - St. Luke's Cancer Institute - Liberty
  - North Kansas City, Missouri, United States, 64116
    - University of Kansas Cancer Center
  - Saint Joseph, Missouri, United States, 64507
    - Heartland Regional Medical Center/dba Cancer Care St. Joseph Mosaic Life Care
  - Saint Louis, Missouri, United States, 63109
    - Mercy Clinic St. Louis Cancer and Breast Institute
  - Saint Louis, Missouri, United States, 63141
    - Mercy Hospital St. Louis
  - Saint Louis, Missouri, United States, 63110
    - St. Louis University Cancer Center
  - Saint Louis, Missouri, United States, 63110
    - SSM Health St. Louis University Hospital
  - Saint Louis, Missouri, United States, 63128
    - St. Louis Cancer Care, LLP
  - Saint Louis, Missouri, United States, 63141
    - Mercy Research - Mercy Heart Hospital St. Louis
- Nebraska
  - Lincoln, Nebraska, United States, 68506
    - Nebraska Hematology/Oncology, PC
- New Hampshire
  - Portsmouth, New Hampshire, United States, 03801
    - Portsmouth Regional Hospital
- New Jersey
  - Hackensack, New Jersey, United States, 07601
    - Hackensack University Medical Center, John Theurer Cancer Center
  - Paramus, New Jersey, United States, 07652
    - The Valley Hospital
  - Phillipsburg, New Jersey, United States, 08865
    - St. Luke's University Heatlh Network - Warren Hospital
- New York
  - Brewster, New York, United States, 10509
    - CareMount Medical
  - East Setauket, New York, United States, 11733
    - New York Cancer and Blood Specialists
  - Mount Kisco, New York, United States, 10549
    - CareMount Medical
  - Mount Kisco, New York, United States, 10549
    - Northern Westchester Hospital
  - Patchogue, New York, United States, 11772
    - New York Cancer and Blood Specialists
  - Port Jefferson Station, New York, United States, 11776
    - New York Cancer and Blood Specialists
  - Riverhead, New York, United States, 11901
    - New York Cancer and Blood Specialists
  - Smithtown, New York, United States, 11787
    - New York Cancer and Blood Specialists
  - White Plains, New York, United States, 10601
    - White Plains Hospital
- North Carolina
  - Asheville, North Carolina, United States, 28803
    - Asheville Hematology and Oncology
  - Clayton, North Carolina, United States, 27520
    - Johnston Health Services Corporation - Clayton
  - Clyde, North Carolina, United States, 28721
    - Haywood Infusion Center
  - Fayetteville, North Carolina, United States, 28304
    - Cape Fear Valley Health System
  - Fayetteville, North Carolina, United States, 28311
    - Cape Fear Valley Health System
  - Greenville, North Carolina, United States, 27834
    - East Carolina University Brody School of Medicine
  - Henderson, North Carolina, United States, 27536
    - DLP Maria Parham Medical Center
  - Hendersonville, North Carolina, United States, 28792
    - Advent Health - Hendersonville
  - High Point, North Carolina, United States, 27262
    - University of North Carolina Regional Physicians Hematology Oncology
  - Kernersville, North Carolina, United States, 27284
    - Novant Health Oncology Specialists
  - Laurinburg, North Carolina, United States, 28352
    - Duke Cancer Network
  - Lumberton, North Carolina, United States, 27358
    - Southeastern Regional Medical Center
  - Mount Airy, North Carolina, United States, 27030
    - Novant Health Oncology Specialists
  - North Wilkesboro, North Carolina, United States, 28659
    - Novant Health Oncology Specialists
  - Smithfield, North Carolina, United States, 27577
    - Johnston Health Services Corporation - Smithfield
  - Statesville, North Carolina, United States, 28687
    - Novant Health Oncology Specialists
  - Thomasville, North Carolina, United States, 27360
    - Novant Health Oncology Specialists
  - Winston-Salem, North Carolina, United States, 27103
    - Novant Health Oncology Specialists
- Ohio
  - Canton, Ohio, United States, 44708
    - Mercy Medical Center
  - Canton, Ohio, United States, 44708
    - Hematology Oncology Associates, Inc.
  - Columbus, Ohio, United States, 43219
    - Mid Ohio Oncology/Hematology, Inc. dba The Mark H. Zangmeister Center
  - Dover, Ohio, United States, 44622
    - Tri-County Hematology and Oncology Associates, Inc.
  - Massilon, Ohio, United States, 44646
    - Tri-County Hematology and Oncology Associates, Inc.
  - Perrysburg, Ohio, United States, 43551
    - Mercy Health Perrysburg Cancer Center
  - Toledo, Ohio, United States, 43608
    - Mercy Health St. Vincent Medical Center
  - Toledo, Ohio, United States, 46323
    - Mercy Health Cancer Center
  - Warren, Ohio, United States, 44484
    - Mercy Health Youngstown dba St Joseph Warren Hospital
  - Youngstown, Ohio, United States, 44501
    - Mercy Health Youngstown dba St. Elizabeth Youngstown Hospital
- Oregon
  - Eugene, Oregon, United States, 97401
    - Willamette Valley Cancer Institute and Research Center
  - Portland, Oregon, United States, 97213
    - Northwest Cancer Specialists, PC
  - Portland, Oregon, United States, 97225
    - Northwest Cancer Specialists, PC
  - Springfield, Oregon, United States, 97477
    - Willamette Valley Cancer Institute and Research Center
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18104
    - St. Luke's Hospital - Allentown Campus
  - Allentown, Pennsylvania, United States, 18102
    - St. Luke's University Health Network - Sacred Heart Hospital
  - Bethlehem, Pennsylvania, United States, 18015
    - St. Luke's Hematology Oncology Specialists
  - Bethlehem, Pennsylvania, United States, 18015
    - St. Luke's University Heatlh Network
  - Bethlehem, Pennsylvania, United States, 18104
    - St. Luke's Hematology Oncology Specialists
  - Easton, Pennsylvania, United States, 18045
    - St. Luke's University Heatlh Network
  - Harrisburg, Pennsylvania, United States, 17109
    - Pinnacle Health Cancer Institute
  - Harrisburg, Pennsylvania, United States, 17109
    - Pinnacle Health Cancer Center
  - Lancaster, Pennsylvania, United States, 17605
    - Lancaster Cancer Center
  - Mechanicsburg, Pennsylvania, United States, 17050
    - Ortenzio Cancer Center at Pinnacle Health
- South Carolina
  - Charleston, South Carolina, United States, 29406
    - Charleston Cancer Center
  - Easley, South Carolina, United States, 29640
    - Greenville Health System
  - Georgetown, South Carolina, United States, 29440
    - Tidelands Waccamaw Oncology/Georgrtown Hospital System
  - Greenville, South Carolina, United States, 29615
    - Greenville Health System
  - Greenville, South Carolina, United States, 29605
    - Greenville Health System
  - Greer, South Carolina, United States, 29650
    - Greenville Health System
  - Lancaster, South Carolina, United States, 29720
    - Carolina Blood and Cancer Care Associates, PA
  - Murrells Inlet, South Carolina, United States, 29576
    - Tidelands Waccamaw Oncology/Georgrtown Hospital System
  - Myrtle Beach, South Carolina, United States, 29577
    - Tidelands Waccamaw Oncology/Georgrtown Hospital System
  - Rock Hill, South Carolina, United States, 29732
    - Carolina Blood and Cancer Care Associates, PA
  - Seneca, South Carolina, United States, 29672
    - Greenville Health System
  - Spartanburg, South Carolina, United States, 29303
    - Spartanburg Regional Medical Center
  - Spartanburg, South Carolina, United States, 29307
    - Greenville Health System
  - Sumter, South Carolina, United States, 29150
    - M. Francisco Gonzalez, MD, PA
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - Wellmont Bristol Regional Medical Center
  - Bristol, Tennessee, United States, 37620
    - Wellmont Medical Associates Oncology and Hematology
  - Chattanooga, Tennessee, United States, 37403
    - University of Tennessee/Erlanger Oncology and Hematology
  - Johnson City, Tennessee, United States, 37601
    - Wellmont Medical Associates Oncology and Hematology
  - Kingsport, Tennessee, United States, 37660
    - Wellmont Holston Valley Medical Center
  - Kingsport, Tennessee, United States, 37660
    - Wellmont Cancer Institute
- Texas
  - Allen, Texas, United States, 75013
    - Texas Oncology -Allen
  - Dallas, Texas, United States, 75246
    - Texas Oncology
  - Denton, Texas, United States, 76210
    - Texas Oncology-Denton South
  - El Paso, Texas, United States, 79902
    - Texas Oncology-El Paso Cancer Treatment Center
  - Fort Worth, Texas, United States, 76104
    - Texas Oncology - Fort Worth Cancer Center
  - Fort Worth, Texas, United States, 76104
    - Texas Oncology
  - Fort Worth, Texas, United States, 76132
    - Texas Oncology - Southwest Fort Worth
  - Houston, Texas, United States, 77030
    - MD Anderson Cancer Center
  - Houston, Texas, United States, 77024
    - Texas Oncology
  - Lubbock, Texas, United States, 79415
    - University Medical Center Health System, Southwest Cancer Center
  - McAllen, Texas, United States, 78503
    - Texas Oncology
  - McKinney, Texas, United States, 75071
    - Texas Oncology - McKinney
  - Mesquite, Texas, United States, 75150
    - Texas Oncology
  - Paris, Texas, United States, 75460
    - Texas Oncology-Paris
  - Plano, Texas, United States, 75075
    - Texas Oncology
  - San Antonio, Texas, United States, 78217
    - Texas Oncology
  - San Antonio, Texas, United States, 78212
    - Texas Oncology-San Antonio Downtown
  - San Antonio, Texas, United States, 78258
    - Texas Oncology-San Antonio Stone Oak
  - Tyler, Texas, United States, 75702
    - Texas Oncology
- Virginia
  - Arlington, Virginia, United States, 22205
    - Virginia Cancer Specialists
  - Bristol, Virginia, United States, 24201
    - Wellmont Medical Associates Oncology and Hematology
  - Chesapeake, Virginia, United States, 23320
    - Cancer Specialists of Tidewater/Riverside Cancer Infusion Center
  - Fairfax, Virginia, United States, 22031
    - Virginia Cancer Specialists
  - Fishersville, Virginia, United States, 22939
    - Augusta Health Cancer Center
  - Gainesville, Virginia, United States, 20155
    - Virginia Cancer Specialists
  - Gloucester, Virginia, United States, 23061
    - Peninsula Cancer Institute/Riverside Cancer Infusion Center
  - Leesburg, Virginia, United States, 20176
    - Virginia Cancer Specialists
  - Mechanicsville, Virginia, United States, 23116
    - Bon Secours Memorial Regional Medical Center, Inc.
  - Mechanicsville, Virginia, United States, 23116
    - Bon Secours Richmond Community Hospital dba Oncology Associates at Memorial Regional Medical Center
  - Midlothian, Virginia, United States, 23114
    - Bon Secours Cancer Institute @ St. Francis Medical Center
  - Midlothian, Virginia, United States, 23114
    - Bon Secours Richmond Community Hospital dba Oncology Associates at St. Francis Medical Center
  - Midlothian, Virginia, United States, 23114
    - Bon Secours St. Francis Medical Center, Inc.
  - Nassawadox, Virginia, United States, 23413
    - Riverside Shore Cancer Center
  - Newport News, Virginia, United States, 23601
    - Peninsula Cancer Institute/Riverside Cancer Infusion Center
  - Norton, Virginia, United States, 24273
    - Southwest Virginia Regional Cancer Center
  - Portsmouth, Virginia, United States, 23704
    - Delta Hematology/Oncology Associates
  - Richmond, Virginia, United States, 23226
    - Bon Secours Richmond Community Hospital dba Oncologists Associates at St. Mary's Hospital
  - Richmond, Virginia, United States, 23226
    - Bon Secours St. Mary's Hospital, Inc.
  - Suffolk, Virginia, United States, 23435
    - Cancer Specialists of Tidewater/Riverside Cancer Infusion Center
  - Virginia Beach, Virginia, United States, 23454
    - Cancer Specialists of Tidewater/Riverside Cancer Infusion Center
  - Williamsburg, Virginia, United States, 23185
    - Peninsula Cancer Institute/Riverside Cancer Infusion Center
- Washington
  - Seattle, Washington, United States, 98109
    - Seattle Cancer Care Alliance
  - Vancouver, Washington, United States, 98684
    - Northwest Cancer Specialists, PC
- West Virginia
  - Bridgeport, West Virginia, United States, 26330
    - West Virginia University Medicine - United Hospital Center
  - Huntington, West Virginia, United States, 25705
    - Huntington Internal Medicine Group
  - Huntington, West Virginia, United States, 25705
    - St. Mary's Medical Center
  - Morgantown, West Virginia, United States, 26506
    - West Virginia University, Mary Babb Randolph Cancer Center
  - Parkersburg, West Virginia, United States, 26101
    - Camden Clark Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

HR+/HER2- ABC patients whose treatment decision with palbociclib has been made by their treating physician and who meet the eligibility criteria will be invited to participate in the study.

Description

Inclusion Criteria

Age ≥18 years or older.
Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to treatment with curative intent.
Documented HR+ (ER+ and/or PR+) tumor based on local standards.
Documented HER2- tumor based on local standards.
Physician has determined that treatment with palbociclib is indicated.
Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
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:

Patients with a life expectancy of less than 3 months at the time of ABC diagnosis, per the investigator's judgment.
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).
Patients on active treatment for malignancies other than ABC at the time of enrollment.
Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent.
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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
non-interventional study This prospective, observational study will be conducted according to each site's routine clinical practice.	Other: non-interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants According to Real-World Tumor Response Time Frame: From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years)	Real world tumor response included complete response (CR), Partial response (PR), Stable disease (SD), Progressive Disease (PD), and was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. Response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria may not be available for all participants. rwTR was derived as the best tumor response recorded from the palbociclib combination treatment start date until the first documentation of progressive disease. Only response assessments recorded on or before the start date of next subsequent line of treatment will be considered.	From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years)
Real-World Tumor Response Rate Time Frame: From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years)	Real world tumor response rate was defined as the percentage of participants with a best tumor response of complete response or partial response. Tumor response was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. RECIST criteria may not be available for all participants.	From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years)
Real World Progression Free Survival Time Frame: From initiation of the palbociclib combination treatment to the earliest of clinician-documented progression or death due to any cause, whichever occurs first. (up to approximately 3 years)	Real world progression free survival was defined as time (months) from initiation of the palbociclib combination treatment to the earliest of clinician-documented progression or death due to any cause, whichever occurred first. Participants without documented disease progression or death were censored at the last date of response assessment.	From initiation of the palbociclib combination treatment to the earliest of clinician-documented progression or death due to any cause, whichever occurs first. (up to approximately 3 years)
Overall Survival Time Frame: From initiation of the palbociclib combination treatment to death due to any cause or censored, (up to approximately 3 years)	Overall survival was defined as time from initiation of the palbociclib combination treatment to date of death due to any cause. Participants without a documented death were censored at last available visit date known to be alive.	From initiation of the palbociclib combination treatment to death due to any cause or censored, (up to approximately 3 years)
Absolute Eastern Co-Operative Oncology Group (ECOG) Performance Status Scores at Baseline: Participants More Than or Equal to 70 Years Only Time Frame: Baseline (last observed measurement prior to treatment start date)	ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).	Baseline (last observed measurement prior to treatment start date)
ECOG Performance Status Scores at Month 1: Participants More Than or Equal to 70 Years Only Time Frame: Month 1	ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).	Month 1
ECOG Performance Status Scores at Month 2: Participants More Than or Equal to 70 Years Only Time Frame: Month 2	ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).	Month 2
ECOG Performance Status Scores at Month 3: Participants More Than or Equal to 70 Years Only Time Frame: Month 3	ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).	Month 3
ECOG Performance Status Scores at Month 6: Participants More Than or Equal to 70 Years Only Time Frame: Month 6	ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).	Month 6
ECOG Performance Status Scores at Month 9: Participants More Than or Equal to 70 Years Only Time Frame: Month 9	ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).	Month 9
ECOG Performance Status Scores at Month 12: Participants More Than or Equal to 70 Years Only Time Frame: Month 12	ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).	Month 12
ECOG Performance Status Scores at Month 15: Participants More Than or Equal to 70 Years Only Time Frame: Month 15	ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).	Month 15
ECOG Performance Status Scores at Month 18: Participants More Than or Equal to 70 Years Only Time Frame: Month 18	ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).	Month 18
ECOG Performance Status Scores at Month 21: Participants More Than or Equal to 70 Years Only Time Frame: Month 21	ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).	Month 21
ECOG Performance Status Scores at Month 24: Participants More Than or Equal to 70 Years Only Time Frame: Month 24	ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).	Month 24
ECOG Performance Status Scores in Month 27: Participants More Than or Equal to 70 Years Only Time Frame: Month 27	ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).	Month 27
ECOG Performance Status Scores at Month 30: Participants More Than or Equal to 70 Years Only Time Frame: Month 30	ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).	Month 30
ECOG Performance Status Scores at Month 33: Participants More Than or Equal to 70 Years Only Time Frame: Month 33	ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).	Month 33
ECOG Performance Status Scores in Month 36: Participants More Than or Equal to 70 Years Only Time Frame: Month 36	ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).	Month 36
ECOG Performance Status Scores at Month 39: Participants More Than or Equal to 70 Years Only Time Frame: Month 39	ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).	Month 39
ECOG Performance Status Scores at Month 42: Participants More Than or Equal to 70 Years Only Time Frame: Month 42	ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).	Month 42
Geriatric 8 Screening Tool Scores at Baseline: Participants More Than or Equal to 70 Years Only Time Frame: Baseline (last observed measurement prior to treatment start date)	The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.	Baseline (last observed measurement prior to treatment start date)
Geriatric 8 Screening Tool Scores at Month 1: Participants More Than or Equal to 70 Years Only Time Frame: Month 1	The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.	Month 1
Geriatric 8 Screening Tool Scores at Month 2: Participants More Than or Equal to 70 Years Only Time Frame: Month 2	The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.	Month 2
Geriatric 8 Screening Tool Scores at Month 3: Participants More Than or Equal to 70 Years Only Time Frame: Month 3	The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.	Month 3
Geriatric 8 Screening Tool Scores at Month 6: Participants More Than or Equal to 70 Years Only Time Frame: Month 6	The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.	Month 6
Geriatric 8 Screening Tool Scores at Month 9: Participants More Than or Equal to 70 Years Only Time Frame: Month 9	The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.	Month 9
Geriatric 8 Screening Tool Scores at Month 12: Participants More Than or Equal to 70 Years Only Time Frame: Month 12	The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.	Month 12
Geriatric 8 Screening Tool Scores at Month 15: Participants More Than or Equal to 70 Years Only Time Frame: Month 15	The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.	Month 15
Geriatric 8 Screening Tool Scores at Month 18: Participants More Than or Equal to 70 Years Only Time Frame: Month 18	The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.	Month 18
Geriatric 8 Screening Tool Scores at Month 21: Participants More Than or Equal to 70 Years Only Time Frame: Month 21	The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.	Month 21
Geriatric 8 Screening Tool Scores at Month 24: Participants More Than or Equal to 70 Years Only Time Frame: Month 24	The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.	Month 24
Geriatric 8 Screening Tool Scores at Month 27: Participants More Than or Equal to 70 Years Only Time Frame: Month 27	The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.	Month 27
Geriatric 8 Screening Tool Scores at Month 30: Participants More Than or Equal to 70 Years Only Time Frame: Month 30	The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.	Month 30
Geriatric 8 Screening Tool Scores at Month 33: Participants More Than or Equal to 70 Years Only Time Frame: Month 33	The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.	Month 33
Geriatric 8 Screening Tool Scores at Month 36: Participants More Than or Equal to 70 Years Only Time Frame: Month 36	The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.	Month 36
Geriatric 8 Screening Tool Scores at Month 39: Participants More Than 70 or Equal to Years Only Time Frame: Month 39	The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.	Month 39
Geriatric 8 Screening Tool Scores at Month 42: Participants More Than or Equal to 70 Years Only Time Frame: Month 42	The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.	Month 42
Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Time Frame: Baseline (last observed measurement prior to treatment start date) and Month 6	European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire 30: 30 item questionnaires composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms.	Baseline (last observed measurement prior to treatment start date) and Month 6
Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Time Frame: Baseline (last observed measurement prior to treatment start date) and Month 12	EORTC QLQ-C30: 30 item questionnaire composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms.	Baseline (last observed measurement prior to treatment start date) and Month 12
Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Time Frame: Baseline (last observed measurement prior to treatment start date) and Month 18	EORTC QLQ-C30: 30 item questionnaire composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms.	Baseline (last observed measurement prior to treatment start date) and Month 18
Activities of Daily Living Scores at Baseline: Participants More Than or Equal to 70 Years Only Time Frame: Baseline (last observed measurement prior to treatment start date)	Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participant.	Baseline (last observed measurement prior to treatment start date)
Activities of Daily Living Scores at Month 1: Participants More Than or Equal to 70 Years Only Time Frame: Month 1	Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.	Month 1
Activities of Daily Living Scores at Month 2: Participants More Than or Equal to 70 Years Only Time Frame: Month 2	Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.	Month 2
Activities of Daily Living Scores at Month 3: Participants More Than or Equal to 70 Years Only Time Frame: Month 3	Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.	Month 3
Activities of Daily Living Scores Month 6: Participants More Than or Equal to 70 Years Only Time Frame: Month 6	Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.	Month 6
Activities of Daily Living Scores at Month 9: Participants More Than or Equal to 70 Years Only Time Frame: Month 9	Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.	Month 9
Activities of Daily Living Scores at Month 12: Participants More Than or Equal to 70 Years Only Time Frame: Month 12	Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.	Month 12
Activities of Daily Living Scores at Month 15: Participants More Than or Equal to 70 Years Only Time Frame: Month 15	Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.	Month 15
Activities of Daily Living Scores at Month 18: Participants More Than or Equal to 70 Years Only Time Frame: Month 18	Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participant.	Month 18
Activities of Daily Living Scores at Month 21: Participants More Than or Equal to 70 Years Only Time Frame: Month 21	Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.	Month 21
Activities of Daily Living Scores at Month 24: Participants More Than or Equal to 70 Years Only Time Frame: Month 24	Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.	Month 24
Activities of Daily Living Scores at Month 27: Participants More Than or Equal to 70 Years Only Time Frame: Month 27	Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.	Month 27
Activities of Daily Living Scores at Month 30: Participants More Than or Equal to 70 Years Only Time Frame: Month 30	Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.	Month 30
Activities of Daily Living Scores at Month 33: Participants More Than or Equal to 70 Years Only Time Frame: Month 33	Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.	Month 33
Activities of Daily Living Scores at Month 36: Participants More Than or Equal to 70 Years Only Time Frame: Month 36	Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.	Month 36
Activities of Daily Living Scores at Month 39: Participants More Than or Equal to 70 Years Only Time Frame: Month 39	Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.	Month 39
Activities of Daily Living Scores at Month 42: Participants More Than or Equal to 70 Years Only Time Frame: Month 42	Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.	Month 42
Number of Participants With Adverse Events Time Frame: From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years)	An adverse event is any untoward medical occurrence in administered medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage.	From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years)
Number of Participants With Serious Adverse Events Time Frame: From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years).	A serious adverse event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect.	From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years).
Number of Participants With Any Clinical Laboratory Abnormalities Time Frame: From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years).	Following lab parameters were assessed Anemia, Hemoglobin increased, Lymphocyte count decreased, Lymphocyte count increased, Neutrophil count decreased, Platelet count decreased, Leukocyte count decreased, Leukocyte count increased, Number of participants with any lab abnormality was reported.	From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Tripathy D, Blum JL, Rocque GB, Bardia A, Karuturi MS, Cappelleri JC, Liu Y, Zhang Z, Davis KL, Wang Y. POLARIS: a prospective, multicenter, noninterventional study assessing palbociclib in hormone receptor-positive advanced breast cancer. Future Oncol. 2020 Nov;16(31):2475-2485. doi: 10.2217/fon-2020-0573. Epub 2020 Aug 13.

Helpful Links

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2017

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

December 22, 2022

Study Registration Dates

First Submitted

September 1, 2017

First Submitted That Met QC Criteria

September 8, 2017

First Posted (Actual)

September 12, 2017

Study Record Updates

Last Update Posted (Actual)

September 20, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

A5481082
POLARIS (Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Palbociclib in Real World Practice

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

Study Overview

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Study record dates

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Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Advanced Breast Cancer

Clinical Trials on non-interventional

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