Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer

April 9, 2026 updated by: Alliance for Clinical Trials in Oncology

A Phase II Trial Assessing the Tolerability of Palbociclib in Combination With Letrozole or Fulvestrant in Patients Aged 70 and Older With Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer

This phase II trial studies the side effects and how well palbociclib and letrozole or fulvestrant works in treating patients aged 70 years and older with estrogen receptor positive, HER2 negative breast cancer that has spread to other places in the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as letrozole or fulvestrant, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib and letrozole or fulvestrant may work better in treating patients with breast cancer. The trial will explore factors other than chronologic age that can affect toxicity rates as identified using a cancer-specific geriatric assessment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To estimate the safety and tolerability (adverse event rate) of the combination of palbociclib and letrozole or fulvestrant in adults age 70 or older with estrogen receptor-positive, HER2-negative metastatic breast cancer.

SECONDARY OBJECTIVES:

I. To describe the full toxicity profile including all grade 2 and higher adverse events (per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v.] 5.0), specifically estimating the rate of grade 2 and higher myelosuppression (neutropenia, leukopenia, thrombocytopenia, and anemia), neutropenic fever, gastrointestinal (GI) side effects (nausea, diarrhea, decreased appetite, vomiting, mucositis-oral), fatigue, neuropathy, and thromboembolism.

II. To describe rates of dose reductions, dose holds, and hospitalizations. III. To estimate median time to treatment failure, including progression free survival and overall survival.

IV. To estimate the rate of adherence to palbociclib, letrozole and fulvestrant.

V. To explore factors other than chronologic age that can affect toxicity rates as identified using a cancer-specific geriatric assessment.

VI. To describe the results of the Overall Treatment Utility (OTU). VII. To determine the degree of agreement between patient-reported adverse events (AEs) using Patient Reported Outcomes (PRO)-CTCAE measures and those reported using traditional collections for AEs.

VIII. To examine the association between sarcopenia and the development of toxicity and adverse events.

OUTLINE:

Patients receive palbociclib orally (PO) once daily (QD) on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant intramuscularly (IM) on days 1 and 15 of course 1 and on day 1 of subsequent courses per Doctor of Medicine (MD) discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for up to 5 years.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

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

United States
- Alaska
  - Anchorage, Alaska, United States, 98508
    - Anchorage Associates in Radiation Medicine
  - Anchorage, Alaska, United States, 99508
    - Alaska Breast Care and Surgery LLC
  - Anchorage, Alaska, United States, 99508
    - Alaska Oncology and Hematology LLC
  - Anchorage, Alaska, United States, 99508
    - Alaska Women's Cancer Care
  - Anchorage, Alaska, United States, 99508
    - Anchorage Oncology Centre
  - Anchorage, Alaska, United States, 99508
    - Katmai Oncology Group
  - Anchorage, Alaska, United States, 99508
    - Providence Alaska Medical Center
  - Anchorage, Alaska, United States, 99504
    - Anchorage Radiation Therapy Center
- Arizona
  - Kingman, Arizona, United States, 86401
    - Kingman Regional Medical Center
- California
  - Arroyo Grande, California, United States, 93420
    - PCR Oncology
  - Burbank, California, United States, 91505
    - Providence Saint Joseph Medical Center/Disney Family Cancer Center
  - Corona, California, United States, 92879
    - City of Hope Corona
  - Duarte, California, United States, 91010
    - City of Hope Comprehensive Cancer Center
  - Lancaster, California, United States, 93534
    - City of Hope Antelope Valley
  - Mission Hills, California, United States, 91345
    - City of Hope Mission Hills
  - Orange, California, United States, 92868
    - Saint Joseph Hospital - Orange
  - Sacramento, California, United States, 95817
    - University of California Davis Comprehensive Cancer Center
  - Santa Clarita, California, United States, 91355
    - City of Hope - Santa Clarita
  - South Pasadena, California, United States, 91030
    - City of Hope South Pasadena
  - Upland, California, United States, 91786
    - City of Hope Upland
  - West Covina, California, United States, 91790
    - City of Hope West Covina
- Colorado
  - Denver, Colorado, United States, 80218
    - SCL Health Saint Joseph Hospital
  - Denver, Colorado, United States, 80204
    - Cancer Center of Colorado at Sloan's Lake
  - Lafayette, Colorado, United States, 80026
    - Good Samaritan Medical Center
  - Wheat Ridge, Colorado, United States, 80033
    - SCL Health Lutheran Medical Center
- Delaware
  - Lewes, Delaware, United States, 19958
    - Beebe Medical Center
  - Newark, Delaware, United States, 19713
    - Helen F Graham Cancer Center
  - Newark, Delaware, United States, 19713
    - Delaware Clinical and Laboratory Physicians PA
  - Newark, Delaware, United States, 19713
    - Medical Oncology Hematology Consultants PA
  - Newark, Delaware, United States, 19718
    - Christiana Care Health System-Christiana Hospital
  - Rehoboth Beach, Delaware, United States, 19971
    - Beebe Health Campus
  - Seaford, Delaware, United States, 19973
    - Nanticoke Memorial Hospital
  - Wilmington, Delaware, United States, 19801
    - Christiana Care Health System-Wilmington Hospital
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20016
    - Sibley Memorial Hospital
- Florida
  - Lakeland, Florida, United States, 33805
    - The Watson Clinic
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - Queen's Medical Center
  - Honolulu, Hawaii, United States, 96817
    - The Cancer Center of Hawaii-Liliha
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, United States, 96813
    - University of Hawaii Cancer Center
  - Honolulu, Hawaii, United States, 96817
    - Hawaii Cancer Care Inc-Liliha
  - Honolulu, Hawaii, United States, 96817
    - Kuakini Medical Center
  - Honolulu, Hawaii, United States, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, United States, 96813
    - Island Urology
  - Honolulu, Hawaii, United States, 96813
    - Hawaii Cancer Care Inc-POB II
  - Honolulu, Hawaii, United States, 96813
    - Hawaii Oncology Inc-POB I
  - Honolulu, Hawaii, United States, 96817
    - Hawaii Oncology Inc-Kuakini
  - Lihue, Hawaii, United States, 96766
    - Wilcox Memorial Hospital and Kauai Medical Clinic
  - ‘Aiea, Hawaii, United States, 96701
    - Pali Momi Medical Center
  - ‘Aiea, Hawaii, United States, 96701
    - The Cancer Center of Hawaii-Pali Momi
  - ‘Aiea, Hawaii, United States, 96701
    - Hawaii Cancer Care - Savio
  - ‘Aiea, Hawaii, United States, 96701
    - Hawaii Oncology Inc-Pali Momi
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Boise, Idaho, United States, 83712
    - Saint Luke's Mountain States Tumor Institute
  - Caldwell, Idaho, United States, 83605
    - Saint Alphonsus Cancer Care Center-Caldwell
  - Coeur d'Alene, Idaho, United States, 83814
    - Kootenai Medical Center
  - Emmett, Idaho, United States, 83617
    - Walter Knox Memorial Hospital
  - Fruitland, Idaho, United States, 83619
    - Saint Luke's Mountain States Tumor Institute - Fruitland
  - Meridian, Idaho, United States, 83642
    - Idaho Urologic Institute-Meridian
  - Meridian, Idaho, United States, 83642
    - Saint Luke's Mountain States Tumor Institute - Meridian
  - Nampa, Idaho, United States, 83686
    - Saint Alphonsus Medical Center-Nampa
  - Nampa, Idaho, United States, 83686
    - Saint Luke's Mountain States Tumor Institute - Nampa
  - Post Falls, Idaho, United States, 83854
    - Kootenai Cancer Center
  - Sandpoint, Idaho, United States, 83864
    - Kootenai Cancer Clinic
  - Twin Falls, Idaho, United States, 83301
    - Saint Luke's Mountain States Tumor Institute-Twin Falls
- Illinois
  - Aurora, Illinois, United States, 60504
    - Rush - Copley Medical Center
  - Bloomington, Illinois, United States, 61704
    - Illinois CancerCare-Bloomington
  - Canton, Illinois, United States, 61520
    - Illinois CancerCare-Canton
  - Carthage, Illinois, United States, 62321
    - Illinois CancerCare-Carthage
  - Centralia, Illinois, United States, 62801
    - Centralia Oncology Clinic
  - Chicago, Illinois, United States, 60611
    - Northwestern University
  - Chicago, Illinois, United States, 60637
    - University of Chicago Comprehensive Cancer Center
  - Danville, Illinois, United States, 61832
    - Carle on Vermilion
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - Cancer Care Specialists of Illinois - Decatur
  - Dixon, Illinois, United States, 61021
    - Illinois CancerCare-Dixon
  - Effingham, Illinois, United States, 62401
    - Crossroads Cancer Center
  - Effingham, Illinois, United States, 62401
    - Carle Physician Group-Effingham
  - Eureka, Illinois, United States, 61530
    - Illinois CancerCare-Eureka
  - Galesburg, Illinois, United States, 61401
    - Western Illinois Cancer Treatment Center
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare-Galesburg
  - Joliet, Illinois, United States, 60435
    - Joliet Oncology-Hematology Associates Limited
  - Kewanee, Illinois, United States, 61443
    - Illinois CancerCare-Kewanee Clinic
  - Macomb, Illinois, United States, 61455
    - Illinois CancerCare-Macomb
  - Mattoon, Illinois, United States, 61938
    - Carle Physician Group-Mattoon/Charleston
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - New Lenox, Illinois, United States, 60451
    - UC Comprehensive Cancer Center at Silver Cross
  - Orland Park, Illinois, United States, 60462
    - University of Chicago Medicine-Orland Park
  - Ottawa, Illinois, United States, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Pekin, Illinois, United States, 61554
    - Illinois CancerCare-Pekin
  - Peoria, Illinois, United States, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, United States, 61615
    - Illinois CancerCare-Peoria
  - Peru, Illinois, United States, 61354
    - Illinois CancerCare-Peru
  - Peru, Illinois, United States, 61354
    - Valley Radiation Oncology
  - Princeton, Illinois, United States, 61356
    - Illinois CancerCare-Princeton
  - Springfield, Illinois, United States, 62781
    - Memorial Medical Center
  - Springfield, Illinois, United States, 62702
    - Southern Illinois University School of Medicine
  - Springfield, Illinois, United States, 62702
    - Springfield Clinic
  - Swansea, Illinois, United States, 62226
    - Cancer Care Specialists of Illinois-Swansea
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
  - Urbana, Illinois, United States, 61801
    - The Carle Foundation Hospital
  - Yorkville, Illinois, United States, 60560
    - Rush-Copley Healthcare Center
- Indiana
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic PC - Ames
  - Ames, Iowa, United States, 50010
    - Mary Greeley Medical Center
  - Boone, Iowa, United States, 50036
    - McFarland Clinic PC-Boone
  - Cedar Rapids, Iowa, United States, 52403
    - Mercy Hospital
  - Cedar Rapids, Iowa, United States, 52403
    - Oncology Associates at Mercy Medical Center
  - Cedar Rapids, Iowa, United States, 52402
    - Physicians' Clinic of Iowa PC
  - Des Moines, Iowa, United States, 50309
    - Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50309
    - Medical Oncology and Hematology Associates-Des Moines
  - Des Moines, Iowa, United States, 50314
    - Broadlawns Medical Center
  - Des Moines, Iowa, United States, 50316
    - Iowa Lutheran Hospital
  - Fort Dodge, Iowa, United States, 50501
    - McFarland Clinic PC-Trinity Cancer Center
  - Fort Dodge, Iowa, United States, 50501
    - Trinity Regional Medical Center
  - Jefferson, Iowa, United States, 50129
    - McFarland Clinic PC-Jefferson
  - Marshalltown, Iowa, United States, 50158
    - McFarland Clinic PC-Marshalltown
  - Sioux City, Iowa, United States, 51101
    - Siouxland Regional Cancer Center
  - West Des Moines, Iowa, United States, 50266-7700
    - Methodist West Hospital
- Kansas
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas - Wichita
- Louisiana
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Medical Center Jefferson
- Maine
  - Bangor, Maine, United States, 04401
    - Eastern Maine Medical Center
  - Brewer, Maine, United States, 04412
    - Lafayette Family Cancer Center-EMMC
- Maryland
  - Baltimore, Maryland, United States, 21287
    - Johns Hopkins University/Sidney Kimmel Cancer Center
  - Bethesda, Maryland, United States, 20889-5600
    - Walter Reed National Military Medical Center
  - Towson, Maryland, United States, 21204
    - UM Saint Joseph Medical Center
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, United States, 02115
    - Brigham and Women's Hospital
  - Boston, Massachusetts, United States, 02111
    - Tufts Medical Center
  - Brighton, Massachusetts, United States, 02135
    - Steward Saint Elizabeth's Medical Center
  - Milford, Massachusetts, United States, 01757
    - Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
  - South Weymouth, Massachusetts, United States, 02190
    - Dana-Farber/Brigham and Women's Cancer Center at South Shore
- Michigan
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - Saint Joseph Mercy Hospital
  - Battle Creek, Michigan, United States, 49017
    - Bronson Battle Creek
  - Bay City, Michigan, United States, 48706
    - McLaren Cancer Institute-Bay City
  - Brighton, Michigan, United States, 48114
    - Saint Joseph Mercy Brighton
  - Brighton, Michigan, United States, 48114
    - IHA Hematology Oncology Consultants-Brighton
  - Canton, Michigan, United States, 48188
    - Saint Joseph Mercy Canton
  - Canton, Michigan, United States, 48188
    - IHA Hematology Oncology Consultants-Canton
  - Caro, Michigan, United States, 48723
    - Caro Cancer Center
  - Chelsea, Michigan, United States, 48118
    - Saint Joseph Mercy Chelsea
  - Chelsea, Michigan, United States, 48118
    - IHA Hematology Oncology Consultants-Chelsea
  - Clarkston, Michigan, United States, 48346
    - McLaren Cancer Institute-Clarkston
  - Clarkston, Michigan, United States, 48346
    - Hematology Oncology Consultants-Clarkston
  - Clarkston, Michigan, United States, 48346
    - Newland Medical Associates-Clarkston
  - Detroit, Michigan, United States, 48201
    - Wayne State University/Karmanos Cancer Institute
  - Detroit, Michigan, United States, 48236
    - Ascension Saint John Hospital
  - East China Township, Michigan, United States, 48054
    - Great Lakes Cancer Management Specialists-Doctors Park
  - Farmington Hills, Michigan, United States, 48334
    - Weisberg Cancer Treatment Center
  - Flint, Michigan, United States, 48532
    - McLaren Cancer Institute-Flint
  - Flint, Michigan, United States, 48532
    - Singh and Arora Hematology Oncology PC
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesee Cancer and Blood Disease Treatment Center
  - Flint, Michigan, United States, 48503
    - Genesee Hematology Oncology PC
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Grand Rapids, Michigan, United States, 49503
    - Spectrum Health at Butterworth Campus
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Academic Hematology Oncology Specialists
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Michigan Breast Specialists-Grosse Pointe Woods
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49048
    - Borgess Medical Center
  - Lansing, Michigan, United States, 48912
    - Sparrow Hospital
  - Lansing, Michigan, United States, 48910
    - McLaren-Greater Lansing
  - Lansing, Michigan, United States, 48912
    - Mid-Michigan Physicians-Lansing
  - Lapeer, Michigan, United States, 48446
    - McLaren Cancer Institute-Lapeer Region
  - Livonia, Michigan, United States, 48154
    - Saint Mary Mercy Hospital
  - Livonia, Michigan, United States, 48154
    - Hope Cancer Clinic
  - Macomb, Michigan, United States, 48044
    - Great Lakes Cancer Management Specialists-Macomb Medical Campus
  - Macomb, Michigan, United States, 48044
    - Michigan Breast Specialists-Macomb Township
  - Marlette, Michigan, United States, 48453
    - Saint Mary's Oncology/Hematology Associates of Marlette
  - Monroe, Michigan, United States, 48162
    - Toledo Clinic Cancer Centers-Monroe
  - Mount Clemens, Michigan, United States, 48043
    - McLaren Cancer Institute-Macomb
  - Mount Pleasant, Michigan, United States, 48858
    - McLaren Cancer Institute-Central Michigan
  - Petoskey, Michigan, United States, 49770
    - McLaren Cancer Institute-Northern Michigan
  - Pontiac, Michigan, United States, 48341
    - Saint Joseph Mercy Oakland
  - Pontiac, Michigan, United States, 48341
    - 21st Century Oncology-Pontiac
  - Pontiac, Michigan, United States, 48341
    - Hope Cancer Center
  - Pontiac, Michigan, United States, 48341
    - Newland Medical Associates-Pontiac
  - Port Huron, Michigan, United States, 48060
    - McLaren-Port Huron
  - Reed City, Michigan, United States, 49677
    - Spectrum Health Reed City Hospital
  - Rochester Hills, Michigan, United States, 48309
    - Great Lakes Cancer Management Specialists-Rochester Hills
  - Saginaw, Michigan, United States, 48601
    - Ascension Saint Mary's Hospital
  - Saginaw, Michigan, United States, 48604
    - Oncology Hematology Associates of Saginaw Valley PC
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Medical Center Saint Joseph
  - Saint Joseph, Michigan, United States, 49085
    - Marie Yeager Cancer Center
  - Sterling Heights, Michigan, United States, 48312
    - Bhadresh Nayak MD PC-Sterling Heights
  - Tawas City, Michigan, United States, 48764
    - Ascension Saint Joseph Hospital
  - Warren, Michigan, United States, 48093
    - Saint John Macomb-Oakland Hospital
  - Warren, Michigan, United States, 48088
    - Advanced Breast Care Center PLLC
  - Warren, Michigan, United States, 48093
    - Great Lakes Cancer Management Specialists-Macomb Professional Building
  - Warren, Michigan, United States, 48093
    - Macomb Hematology Oncology PC
  - Warren, Michigan, United States, 48093
    - Michigan Breast Specialists-Warren
  - West Branch, Michigan, United States, 48661
    - Saint Mary's Oncology/Hematology Associates of West Branch
  - Wyoming, Michigan, United States, 49519
    - Metro Health Hospital
  - Ypsilanti, Michigan, United States, 48106
    - Huron Gastroenterology PC
  - Ypsilanti, Michigan, United States, 48197
    - IHA Hematology Oncology Consultants-Ann Arbor
- Minnesota
  - Aitkin, Minnesota, United States, 56431
    - Riverwood Healthcare Center
  - Bemidji, Minnesota, United States, 56601
    - Sanford Joe Lueken Cancer Center
  - Brainerd, Minnesota, United States, 56401
    - Essentia Health Saint Joseph's Medical Center
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Cambridge, Minnesota, United States, 55008
    - Cambridge Medical Center
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy Hospital
  - Deer River, Minnesota, United States, 56636
    - Essentia Health - Deer River Clinic
  - Detroit Lakes, Minnesota, United States, 56501
    - Essentia Health Saint Mary's - Detroit Lakes Clinic
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Cancer Center
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Saint Mary's Medical Center
  - Duluth, Minnesota, United States, 55805
    - Miller-Dwan Hospital
  - Edina, Minnesota, United States, 55435
    - Fairview-Southdale Hospital
  - Fergus Falls, Minnesota, United States, 56537
    - Lake Region Healthcare Corporation-Cancer Care
  - Fosston, Minnesota, United States, 56542
    - Essentia Health - Fosston
  - Fridley, Minnesota, United States, 55432
    - Unity Hospital
  - Hibbing, Minnesota, United States, 55746
    - Essentia Health Hibbing Clinic
  - Maple Grove, Minnesota, United States, 55369
    - Fairview Maple Grove Medical Center
  - Maplewood, Minnesota, United States, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, United States, 55407
    - Abbott-Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55454
    - Health Partners Inc
  - Monticello, Minnesota, United States, 55362
    - Monticello Cancer Center
  - New Ulm, Minnesota, United States, 56073
    - New Ulm Medical Center
  - Park Rapids, Minnesota, United States, 56470
    - Essentia Health - Park Rapids
  - Princeton, Minnesota, United States, 55371
    - Fairview Northland Medical Center
  - Robbinsdale, Minnesota, United States, 55422
    - North Memorial Medical Health Center
  - Saint Cloud, Minnesota, United States, 56303
    - Coborn Cancer Center at Saint Cloud Hospital
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Sandstone, Minnesota, United States, 55072
    - Essentia Health Sandstone
  - Shakopee, Minnesota, United States, 55379
    - Saint Francis Regional Medical Center
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - Thief River Falls, Minnesota, United States, 56701
    - Sanford Thief River Falls Medical Center
  - Virginia, Minnesota, United States, 55792
    - Essentia Health Virginia Clinic
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology PA-Woodbury
  - Worthington, Minnesota, United States, 56187
    - Sanford Cancer Center Worthington
  - Wyoming, Minnesota, United States, 55092
    - Fairview Lakes Medical Center
- Missouri
  - Ballwin, Missouri, United States, 63011
    - Saint Louis Cancer and Breast Institute-Ballwin
  - Bonne Terre, Missouri, United States, 63628
    - Parkland Health Center-Bonne Terre
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, United States, 63703
    - Southeast Cancer Center
  - Chesterfield, Missouri, United States, 63017
    - Saint Luke's Hospital
  - City of Saint Peters, Missouri, United States, 63376
    - Siteman Cancer Center at Saint Peters Hospital
  - Columbia, Missouri, United States, 65212
    - University of Missouri - Ellis Fischel
  - Creve Coeur, Missouri, United States, 63141
    - Siteman Cancer Center at West County Hospital
  - Farmington, Missouri, United States, 63640
    - Parkland Health Center - Farmington
  - Jefferson City, Missouri, United States, 65109
    - Capital Region Southwest Campus
  - Sainte Genevieve, Missouri, United States, 63670
    - Sainte Genevieve County Memorial Hospital
  - Springfield, Missouri, United States, 65804
    - Mercy Hospital Springfield
  - St Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - St Louis, Missouri, United States, 63129
    - Siteman Cancer Center-South County
  - St Louis, Missouri, United States, 63136
    - Siteman Cancer Center at Christian Hospital
  - St Louis, Missouri, United States, 63131
    - Missouri Baptist Medical Center
  - St Louis, Missouri, United States, 63141
    - Mercy Hospital Saint Louis
  - St Louis, Missouri, United States, 63128
    - Mercy Hospital South
  - St Louis, Missouri, United States, 63109
    - Saint Louis Cancer and Breast Institute-South City
  - Sullivan, Missouri, United States, 63080
    - Missouri Baptist Sullivan Hospital
  - Sunset Hills, Missouri, United States, 63127
    - Missouri Baptist Outpatient Center-Sunset Hills
  - Washington, Missouri, United States, 63090
    - Mercy Hospital Washington
- Montana
  - Anaconda, Montana, United States, 59711
    - Community Hospital of Anaconda
  - Billings, Montana, United States, 59101
    - Billings Clinic Cancer Center
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Hospital
  - Great Falls, Montana, United States, 59405
    - Benefis Healthcare- Sletten Cancer Institute
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Missoula, Montana, United States, 59804
    - Community Medical Hospital
  - Missoula, Montana, United States, 59802
    - Saint Patrick Hospital - Community Hospital
- Nebraska
  - Omaha, Nebraska, United States, 68114
    - Nebraska Methodist Hospital
- Nevada
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada - Henderson
  - Henderson, Nevada, United States, 89052
    - OptumCare Cancer Care at Seven Hills
  - Henderson, Nevada, United States, 89052
    - Las Vegas Cancer Center-Henderson
  - Henderson, Nevada, United States, 89074
    - Comprehensive Cancer Centers of Nevada-Southeast Henderson
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada-Horizon Ridge
  - Las Vegas, Nevada, United States, 89106
    - Radiation Oncology Centers of Nevada Central
  - Las Vegas, Nevada, United States, 89119
    - Radiation Oncology Centers of Nevada Southeast
  - Las Vegas, Nevada, United States, 89128
    - Comprehensive Cancer Centers of Nevada - Northwest
  - Las Vegas, Nevada, United States, 89128
    - OptumCare Cancer Care at MountainView
  - Las Vegas, Nevada, United States, 89144
    - Comprehensive Cancer Centers of Nevada - Town Center
  - Las Vegas, Nevada, United States, 89144
    - Comprehensive Cancer Centers of Nevada-Summerlin
  - Las Vegas, Nevada, United States, 89148
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89148
    - OptumCare Cancer Care at Fort Apache
  - Las Vegas, Nevada, United States, 89169
    - Comprehensive Cancer Centers of Nevada - Central Valley
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89148-2405
    - Las Vegas Cancer Center-Medical Center
  - Las Vegas, Nevada, United States, 89102
    - Desert West Surgery
  - Las Vegas, Nevada, United States, 89102
    - OptumCare Cancer Care at Oakey
  - Las Vegas, Nevada, United States, 89103
    - Hope Cancer Care of Nevada
  - Pahrump, Nevada, United States, 89048
    - Hope Cancer Care of Nevada-Pahrump
  - Reno, Nevada, United States, 89502
    - Renown Regional Medical Center
  - Reno, Nevada, United States, 89509
    - Radiation Oncology Associates
- New Hampshire
  - Concord, New Hampshire, United States, 03301
    - New Hampshire Oncology Hematology PA-Concord
  - Hooksett, New Hampshire, United States, 03106
    - New Hampshire Oncology Hematology PA-Hooksett
  - Londonderry, New Hampshire, United States, 03053
    - The Dana-Farber Cancer Institute at Londonderry
- New Jersey
  - Cape May Court House, New Jersey, United States, 08210
    - AtlantiCare Health Park-Cape May Court House
  - Egg Harbor, New Jersey, United States, 08234
    - AtlantiCare Surgery Center
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - University of New Mexico Cancer Center
  - Albuquerque, New Mexico, United States, 87102
    - Lovelace Medical Center-Saint Joseph Square
  - Albuquerque, New Mexico, United States, 87110
    - Presbyterian Kaseman Hospital
  - Rio Rancho, New Mexico, United States, 87124
    - Presbyterian Rust Medical Center/Jorgensen Cancer Center
  - Santa Fe, New Mexico, United States, 87505
    - Christus Saint Vincent Regional Cancer Center
- New York
  - Auburn, New York, United States, 13021
    - Hematology Oncology Associates of Central New York-Auburn
  - Bay Shore, New York, United States, 11706
    - Northwell Health Imbert Cancer Center
  - Buffalo, New York, United States, 14263
    - Roswell Park Cancer Institute
  - East Syracuse, New York, United States, 13057
    - Hematology Oncology Associates of Central New York-East Syracuse
  - Glens Falls, New York, United States, 12801
    - Glens Falls Hospital
  - Greenlawn, New York, United States, 11740
    - Northwell Health Cancer Institute at Huntington
  - Lake Success, New York, United States, 11042
    - Northwell Health/Center for Advanced Medicine
  - Stony Brook, New York, United States, 11794
    - Stony Brook University Medical Center
  - Syracuse, New York, United States, 13215
    - Hematology Oncology Associates of Central New York-Onondaga Hill
  - The Bronx, New York, United States, 10461
    - Montefiore Medical Center-Einstein Campus
  - The Bronx, New York, United States, 10467
    - Montefiore Medical Center - Moses Campus
  - The Bronx, New York, United States, 10461
    - Montefiore Medical Center-Weiler Hospital
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599
    - UNC Lineberger Comprehensive Cancer Center
  - Clinton, North Carolina, United States, 28328
    - Southeastern Medical Oncology Center-Clinton
  - Durham, North Carolina, United States, 27710
    - Duke University Medical Center
  - Goldsboro, North Carolina, United States, 27534
    - Southeastern Medical Oncology Center-Goldsboro
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital
  - Jacksonville, North Carolina, United States, 28546
    - Southeastern Medical Oncology Center-Jacksonville
  - Kernersville, North Carolina, United States, 27284
    - Novant Health Oncology Specialists-Kernersville
  - Mount Airy, North Carolina, United States, 27030
    - Novant Health Oncology Specialists-Mount Airy
  - New Bern, North Carolina, United States, 28561
    - CarolinaEast Medical Center
  - New Bern, North Carolina, United States, 28562
    - CarolinaEast Oncology and Hematology Associates
  - Statesville, North Carolina, United States, 28625
    - Novant Health Oncology Specialists-Statesville
  - Thomasville, North Carolina, United States, 27360
    - Novant Health Oncology Specialists-Davidson County
  - Wilkesboro, North Carolina, United States, 28659
    - Novant Health Oncology Specialists-Wilkesboro
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest University Health Sciences
  - Winston-Salem, North Carolina, United States, 27103
    - Novant Health Forsyth Medical Center
  - Winston-Salem, North Carolina, United States, 27103
    - Novant Health Oncology Specialists
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Sanford Bismarck Medical Center
  - Fargo, North Dakota, United States, 58122
    - Sanford Roger Maris Cancer Center
  - Fargo, North Dakota, United States, 58103
    - Essentia Health Cancer Center-South University Clinic
  - Fargo, North Dakota, United States, 58122
    - Sanford Broadway Medical Center
  - Fargo, North Dakota, United States, 58103
    - Sanford South University Medical Center
  - Fargo, North Dakota, United States, 58104
    - Sanford Medical Center Fargo
  - Grand Forks, North Dakota, United States, 58201
    - Altru Cancer Center
  - Jamestown, North Dakota, United States, 58401
    - Essentia Health - Jamestown Clinic
- Ohio
  - Belpre, Ohio, United States, 45714
    - Strecker Cancer Center-Belpre
  - Canton, Ohio, United States, 44708
    - Mercy Medical Center
  - Columbus, Ohio, United States, 43219
    - The Mark H Zangmeister Center
  - Columbus, Ohio, United States, 43213
    - Mount Carmel East Hospital
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health Center West
  - Delaware, Ohio, United States, 43015
    - Delaware Health Center-Grady Cancer Center
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Grove City, Ohio, United States, 43123
    - Mount Carmel Grove City Hospital
  - Marietta, Ohio, United States, 45750
    - Marietta Memorial Hospital
  - Perrysburg, Ohio, United States, 43551
    - Mercy Health Perrysburg Cancer Center
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic Cancer Centers-Toledo
  - Toledo, Ohio, United States, 43623
    - Mercy Saint Anne Hospital
  - Westerville, Ohio, United States, 43081
    - Saint Ann's Hospital
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73120
    - Mercy Hospital Oklahoma City
- Oregon
  - Baker City, Oregon, United States, 97814
    - Saint Alphonsus Medical Center-Baker City
  - Bend, Oregon, United States, 97701
    - Saint Charles Health System
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Clackamas, Oregon, United States, 97015
    - Providence Cancer Institute Clackamas Clinic
  - Coos Bay, Oregon, United States, 97420
    - Bay Area Hospital
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Ontario, Oregon, United States, 97914
    - Saint Alphonsus Medical Center-Ontario
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - Providence Saint Vincent Medical Center
  - Redmond, Oregon, United States, 97756
    - Saint Charles Health System-Redmond
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18103
    - Lehigh Valley Hospital-Cedar Crest
  - Bethlehem, Pennsylvania, United States, 18017
    - Lehigh Valley Hospital - Muhlenberg
  - Chadds Ford, Pennsylvania, United States, 19317
    - Christiana Care Health System-Concord Health Center
  - Danville, Pennsylvania, United States, 17822
    - Geisinger Medical Center
  - East Stroudsburg, Pennsylvania, United States, 18301
    - Pocono Medical Center
  - Ephrata, Pennsylvania, United States, 17522
    - Ephrata Cancer Center
  - Ephrata, Pennsylvania, United States, 17522
    - Ephrata Community Hospital
  - Gettysburg, Pennsylvania, United States, 17325
    - Adams Cancer Center
  - Hanover, Pennsylvania, United States, 17331
    - Cherry Tree Cancer Center
  - Harrisburg, Pennsylvania, United States, 17109
    - UPMC Pinnacle Cancer Center/Community Osteopathic Campus
  - Harrisburg, Pennsylvania, United States, 17101
    - UPMC Pinnacle Harrisburg
  - Hazleton, Pennsylvania, United States, 18201
    - Geisinger Medical Center-Cancer Center Hazleton
  - Hazleton, Pennsylvania, United States, 18201
    - Lehigh Valley Hospital-Hazleton
  - Lebanon, Pennsylvania, United States, 17042
    - Sechler Family Cancer Center
  - Lewisburg, Pennsylvania, United States, 17837
    - Geisinger Medical Oncology-Lewisburg
  - Pittsburgh, Pennsylvania, United States, 15232
    - University of Pittsburgh Cancer Institute (UPCI)
  - Pottsville, Pennsylvania, United States, 17901
    - Geisinger Cancer Services-Pottsville
  - Sayre, Pennsylvania, United States, 18840
    - Guthrie Medical Group PC-Robert Packer Hospital
  - Scranton, Pennsylvania, United States, 18510
    - Community Medical Center
  - Selinsgrove, Pennsylvania, United States, 17870
    - Geisinger Medical Oncology-Selinsgrove
  - State College, Pennsylvania, United States, 16801
    - Geisinger Medical Group
  - West Reading, Pennsylvania, United States, 19611
    - Reading Hospital
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Geisinger Wyoming Valley/Henry Cancer Center
  - Williamsport, Pennsylvania, United States, 17701
    - UPMC Susquehanna
  - York, Pennsylvania, United States, 17403
    - WellSpan Health-York Cancer Center
  - York, Pennsylvania, United States, 17403
    - WellSpan Health-York Hospital
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina
  - West Columbia, South Carolina, United States, 29169
    - Lexington Medical Center
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Rapid City Regional Hospital
  - Sioux Falls, South Dakota, United States, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, United States, 57104
    - Sanford Cancer Center Oncology Clinic
- Utah
  - Farmington, Utah, United States, 84025
    - Farmington Health Center
  - Salt Lake City, Utah, United States, 84112
    - Huntsman Cancer Institute/University of Utah
  - South Jordan, Utah, United States, 84009
    - South Jordan Health Center
- Vermont
  - Berlin Corners, Vermont, United States, 05602
    - Central Vermont Medical Center/National Life Cancer Treatment
  - Burlington, Vermont, United States, 05401
    - University of Vermont Medical Center
  - Burlington, Vermont, United States, 05405
    - University of Vermont and State Agricultural College
- Virginia
  - Lynchburg, Virginia, United States, 24501
    - Centra Lynchburg Hematology-Oncology Clinic Inc
  - Martinsville, Virginia, United States, 24115
    - Sovah Health Martinsville
  - Mechanicsville, Virginia, United States, 23116
    - Bon Secours Memorial Regional Medical Center
  - Midlothian, Virginia, United States, 23114
    - Bon Secours Saint Francis Medical Center
  - Norfolk, Virginia, United States, 23505
    - Bon Secours DePaul Medical Center
  - Richmond, Virginia, United States, 23235
    - VCU Massey Cancer Center at Stony Point
  - Richmond, Virginia, United States, 23298
    - Virginia Commonwealth University/Massey Cancer Center
  - Richmond, Virginia, United States, 23230
    - Virginia Cancer Institute
  - Richmond, Virginia, United States, 23226
    - Bon Secours Saint Mary's Hospital
  - Richmond, Virginia, United States, 23230
    - Bon Secours Cancer Institute at Reynolds Crossing
  - South Hill, Virginia, United States, 23970
    - VCU Community Memorial Health Center
  - Suffolk, Virginia, United States, 23435
    - Bon Secours Health Center at Harbour View
  - Winchester, Virginia, United States, 22601
    - Shenandoah Oncology PC
- Washington
  - Aberdeen, Washington, United States, 98520
    - Providence Regional Cancer System-Aberdeen
  - Bellingham, Washington, United States, 98225
    - PeaceHealth Saint Joseph Medical Center
  - Centralia, Washington, United States, 98531
    - Providence Regional Cancer System-Centralia
  - Edmonds, Washington, United States, 98026
    - Swedish Cancer Institute-Edmonds
  - Everett, Washington, United States, 98201
    - Providence Regional Cancer Partnership
  - Issaquah, Washington, United States, 98029
    - Swedish Cancer Institute-Issaquah
  - Kennewick, Washington, United States, 99336
    - Kadlec Clinic Hematology and Oncology
  - Lacey, Washington, United States, 98503
    - Providence Regional Cancer System-Lacey
  - Longview, Washington, United States, 98632
    - PeaceHealth Saint John Medical Center
  - Renton, Washington, United States, 98055
    - Valley Medical Center
  - Seattle, Washington, United States, 98107
    - Swedish Medical Center-Ballard Campus
  - Seattle, Washington, United States, 98112
    - Kaiser Permanente Washington
  - Seattle, Washington, United States, 98104
    - Pacific Gynecology Specialists
  - Seattle, Washington, United States, 98122-4307
    - Swedish Medical Center-First Hill
  - Seattle, Washington, United States, 98122-5711
    - Swedish Medical Center-Cherry Hill
  - Sedro-Woolley, Washington, United States, 98284
    - PeaceHealth United General Medical Center
  - Shelton, Washington, United States, 98584
    - Providence Regional Cancer System-Shelton
  - Vancouver, Washington, United States, 98664
    - PeaceHealth Southwest Medical Center
  - Walla Walla, Washington, United States, 99362
    - Providence Saint Mary Regional Cancer Center
  - Yelm, Washington, United States, 98597
    - Providence Regional Cancer System-Yelm
- Wisconsin
  - Ashland, Wisconsin, United States, 54806
    - Duluth Clinic Ashland
  - Ashland, Wisconsin, United States, 54806
    - Northwest Wisconsin Cancer Center
  - Chippewa Falls, Wisconsin, United States, 54729
    - Marshfield Clinic-Chippewa Center
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Medical Center-EC Cancer Center
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Medical Center
  - Ladysmith, Wisconsin, United States, 54848
    - Marshfield Clinic - Ladysmith Center
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Medical Center-Marshfield
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic-Minocqua Center
  - New Richmond, Wisconsin, United States, 54017
    - Cancer Center of Western Wisconsin
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Medical Center-Rice Lake
  - Stevens Point, Wisconsin, United States, 54482
    - Marshfield Clinic Stevens Point Center
  - Wausau, Wisconsin, United States, 54401
    - Marshfield Clinic-Wausau Center
  - Weston, Wisconsin, United States, 54476
    - Marshfield Clinic - Weston Center
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Marshfield Clinic - Wisconsin Rapids 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

70 years and older (Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Documentation of disease: estrogen receptor positive and/or progesterone receptor (PR) positive, HER2 negative metastatic breast cancer; histologic confirmation is required
Measurable disease or non-measurable disease
Planning to begin palbociclib for metastatic disease; one prior line of endocrine therapy and/or chemotherapy for metastatic disease is allowed; patients may begin or have already begun endocrine therapy before they start palbociclib treatment, but no more than two weeks prior to registration
No prior therapy with a CDK inhibitor
Resolution of all acute toxic effects of prior therapy or surgical procedures to CTCAE grade =< 1 (except alopecia) or to baseline toxicities prior to previous therapy or surgical procedures, prior to registration
No untreated brain metastases; patients with treated brain metastases must have completed treatment with steroids to be eligible
No known interstitial lung disease
No second malignancies other than non-melanoma skin cancers or cervical carcinoma in situ; however, patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for >= 3 years
No active infection requiring treatment with antibiotics
Patients must be able to swallow and retain oral medication
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
Patients must be able to read and comprehend English or Spanish
Absolute neutrophil count (ANC) >= 1500/mm^3 (1.5 x 10^9/L)
Platelet count >= 100,000/mm^3 (100 x 10^9/L)
Creatinine clearance >= 30 ml/min calculated using the Cockcroft-Gault formula
Total serum bilirubin =< 1.5 upper limit of normal (ULN) (< 3 ULN if Gilbert's disease)
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 3 x ULN (=< 5.0 x ULN if liver metastases present)
Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN if bone or liver metastases present)

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

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (palbociclib, letrozole or fulvestrant) Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Other: Quality-of-Life Assessment Ancillary studies Other: Questionnaire Administration Ancillary studies Drug: Palbociclib Given PO Drug: Letrozole Given PO Drug: Fulvestrant Given IM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events Time Frame: 6 months	Defined as the proportion of patients with documentation of grade 3 - 5 toxicity (regardless of attribution using the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v.] 5.0 criteria). A 95% binomial confidence interval for single proportions will be constructed for the severe toxicity rate during treatment. Univariate relationships between the primary endpoint and various pre-treatment patient characteristics such as anemia, self-assessed functional status, or social support will be described via cross-tabulation and Fisher's exact testing. Exploratory logistic regression modeling, with limited generalizability due to the modest sample size, will be used to assess the relative contributions of these variables impact the likelihood of developing a severe toxicity during treatment. The strength of this association will be expressed in terms of an odds ratio and its associated 95% confidence interval.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Treatment Failure (and Reason for Coming Off Study - Toxicity, Patient Preference, Progression) Time Frame: Up to 5 years	Distributions time to treatment failure will be estimated using Kaplan-Meier methodology. Treatment failure is defined as a severe adverse event, disease progression or patient refusal to continue assigned treatment. Any reason that treatment is discontinued to time to treatment failure and not censor patients will be included. The reason for treatment discontinuation will be captured.	Up to 5 years
Palbociclib Adherence Rate Time Frame: Up to 12 weeks	Patients to be included in the analysis cohort will be those patients who have taken one or more doses of the study treatment. Those patients will be considered adherent to study treatment. For each of the first 3 cycles, an estimate of the proportion of patients who meet the criteria for adherence and its corresponding 95% confidence interval will be determined.	Up to 12 weeks
Response Rate as Determined by Response Evaluation Criteria in Solid Tumors (RECIST) Time Frame: Up to 1 year	The response rate is defined as the proportion of patients whose disease status met Response Evaluation Criteria in Solid Tumors (RECIST) criteria for complete response (CR) or partial response (PR) on 2 consecutive evaluations at least 8 weeks apart. A 95% binomial confidence interval for the response rate will be constructed.	Up to 1 year
Overall Treatment Utility (OTU) Results Time Frame: Up to 1 year	OTU is a novel composite endpoint developed by investigators of the FOCUS2 trial to assess the outcome of palliative chemotherapy. The patient will be given either an overall score of "good", "intermediate", or "poor". A 95% binomial confidence interval will be constructed for the percentage of patients that scored "good" on the OTU.	Up to 1 year
Sarcopenia Analysis Time Frame: Up to 1 year	Will examine variables associated with skeletal muscle loss during treatment and whether skeletal muscle loss during treatment is associated with the presence of grade 3-5 toxicity and adverse events. Sarcopenia will be treated as a binary variable using the Skeletal Muscle Index (SMI) (SMI < 41 cm^2/m^2 vs. SMI > 41 cm^2/m^2) and differences in grades chemotherapy toxicity and adverse events will be analyzed using two group t-tests and fisher's exact test. The number of patients with and without sarcopenia grouped by patients with or without grade 3+ Adverse Events (AE's) will be also be reported.	Up to 1 year
Commonality of Grade 3+ Drug Toxicities Time Frame: 1 year	Measured by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v. 5.0. Reported in this section is the percentage of patients that experienced a grade 3 or higher toxicity.	1 year
Dose Reduction, Dose Hold, and Hospitalization Reasons Time Frame: Up to 1 year	Dosing interruption and/or dose reductions are recommended based on individual safety and tolerability. Palbociclib cycle length will remain 28 days (± 2 days) (despite a delay in initiating a new cycle of palbociclib); endocrine therapy may continue to be administered per the preplanned schedule. Dose holds/reductions of letrozole or fulvestrant will occur per the package insert and the treating investigator's discretion. Dose escalation will not be permitted in this study. Palbociclib doses missed for toxicity will not be made up. The initiation of a new cycle may be delayed for up to 7 days	Up to 1 year
Progression Free Survival (PFS) Time Frame: up to 5 years	Distributions of progression free survival (PFS) times will be estimated using Kaplan-Meier methodology. The PFS time is calculated as the time between a patients start of treatment and their disease progression or death.	up to 5 years
Overall Survival (OS) Time Frame: Up to 5 years	Distributions of overall survival (OS) times will be estimated using Kaplan-Meier methodology. OS time is calculated as the time between the date a patient started treatment and their death.	Up to 5 years
Quality of Life as Measured by the European Quality of Life Five Dimension Three Level Questionnaire (EQ-5D-3L) Time Frame: Up to 1 year	European Quality of Life Five Dimension Three Level Questionnaire (EQ-5D-3L) is comprised of 5 dimensions. Mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, no problems, some problems, extreme problems. The EQ-5D-3L can be converted to a single summary index, 0-1, where higher scores mean better health. The median and range of this total score will be reported.	Up to 1 year

Collaborators and Investigators

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

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Mina Sedrak, MD, MS, City of Hope Comprehensive Cancer Center

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

Sedrak MS, Lee MK, Ji J, Satele DV, Freedman RA, Poorvu PD, O'Connor T, Williams GR, Hopkins JO, Muss HB, Cohen HJ, Partridge AH, Carey LA, Chow SL, Subbiah N, Le-Rademacher J, Jatoi A. Palbociclib in adults aged 70 years and older with advanced breast cancer: A phase 2 multicenter trial (Alliance A171601). J Geriatr Oncol. 2024 Jul;15(6):101813. doi: 10.1016/j.jgo.2024.101813. Epub 2024 Jun 8.

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)

August 15, 2018

Primary Completion (Actual)

September 8, 2020

Study Completion (Actual)

February 27, 2026

Study Registration Dates

First Submitted

August 7, 2018

First Submitted That Met QC Criteria

August 15, 2018

First Posted (Actual)

August 16, 2018

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

A171601
NCI-2017-01596 (Registry Identifier: NCI Clinical Trial Reporting Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Yes

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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Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy

Unspecified Adult Solid Tumor, Protocol Specific | Malignant Neoplasm

United States
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Recruiting

Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies

Monoclonal Gammopathy of Undetermined Significance | Smoldering Plasma Cell Myeloma

United States
Kantonsspital Aarau

Recruiting

Validation of the VascuQoL-6 Questionnaire to Assess ePROM After Revascularization for Lower Limb Peripheral Arterial Disease in German-speaking Part of Switzerland (VascuQol6ValCH)

Peripheral Arterial Disease

Switzerland
Jonsson Comprehensive Cancer Center

Withdrawn

Quality of Life After Bladder-Preservation Chemotherapy and Radiation Therapy in Patients With Muscle-Invasive Bladder Cancer

Infiltrating Bladder Urothelial Carcinoma

United States
University of Southern California
National Cancer Institute (NCI)

Terminated

Patient Navigation and Tailored Treatment Planning in Latina Patients With Breast Cancer

Breast Carcinoma

United States
Case Comprehensive Cancer Center

Active, not recruiting

Stereotactic Radiosurgery in Treating Patients With Large Brain Metastases

Unspecified Adult Solid Tumor | Tumors Metastatic to Brain

United States
M.D. Anderson Cancer Center

Recruiting

Evaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal Cancer

Stage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Stage IV Rectal Cancer AJCC v8 | Stage IVA Rectal Cancer AJCC v8 | Stage IVB Rectal Cancer AJCC v8 | Stage IVC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage... and other conditions

United States
M.D. Anderson Cancer Center

Recruiting

Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy

Hematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | Breast Carcinoma | Head and Neck Carcinoma | Lung Carcinoma | Esophageal Carcinoma | Malignant Digestive System Neoplasm | Malignant Central Nervous System Neoplasm | Genitourinary System Carcinoma

United States

Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer

A Phase II Trial Assessing the Tolerability of Palbociclib in Combination With Letrozole or Fulvestrant in Patients Aged 70 and Older With Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer

Study Overview

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product manufactured in and exported from the U.S.

Clinical Trials on HER2/Neu Negative

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