Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer
NCT ID: NCT03633331
Last Updated: 2021-10-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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UNKNOWN
PHASE2
93 participants
INTERVENTIONAL
2018-08-15
2024-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Palbociclib
Given PO
Letrozole
Given PO
Fulvestrant
Given IM
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Interventions
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Palbociclib
Given PO
Letrozole
Given PO
Fulvestrant
Given IM
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Eligibility Criteria
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Inclusion Criteria
* 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)
70 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Mina Sedrak, MD, MS
Role: STUDY_CHAIR
City of Hope Comprehensive Cancer Center
Locations
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Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States
Alaska Women's Cancer Care
Anchorage, Alaska, United States
Anchorage Oncology Centre
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Kingman Regional Medical Center
Kingman, Arizona, United States
PCR Oncology
Arroyo Grande, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
City of Hope Corona
Corona, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
City of Hope Antelope Valley
Lancaster, California, United States
City of Hope Mission Hills
Mission Hills, California, United States
Saint Joseph Hospital - Orange
Orange, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
City of Hope - Santa Clarita
Santa Clarita, California, United States
City of Hope South Pasadena
South Pasadena, California, United States
City of Hope Upland
Upland, California, United States
City of Hope West Covina
West Covina, California, United States
Cancer Center of Colorado at Sloan's Lake
Denver, Colorado, United States
SCL Health Saint Joseph Hospital
Denver, Colorado, United States
Good Samaritan Medical Center
Lafayette, Colorado, United States
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, United States
Beebe Medical Center
Lewes, Delaware, United States
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Nanticoke Memorial Hospital
Seaford, Delaware, United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
The Watson Clinic
Lakeland, Florida, United States
Hawaii Cancer Care Inc-POB II
Honolulu, Hawaii, United States
Hawaii Oncology Inc-POB I
Honolulu, Hawaii, United States
Island Urology
Honolulu, Hawaii, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Straub Clinic and Hospital
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, United States
Hawaii Oncology Inc-Kuakini
Honolulu, Hawaii, United States
Kuakini Medical Center
Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States
Hawaii Cancer Care - Savio
‘Aiea, Hawaii, United States
Hawaii Oncology Inc-Pali Momi
‘Aiea, Hawaii, United States
Pali Momi Medical Center
‘Aiea, Hawaii, United States
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States
Kootenai Medical Center
Coeur d'Alene, Idaho, United States
Walter Knox Memorial Hospital
Emmett, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho, United States
Saint Alphonsus Medical Center-Nampa
Nampa, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Nampa
Nampa, Idaho, United States
Kootenai Cancer Center
Post Falls, Idaho, United States
Kootenai Cancer Clinic
Sandpoint, Idaho, United States
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho, United States
Rush - Copley Medical Center
Aurora, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Centralia Oncology Clinic
Centralia, Illinois, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Carle on Vermilion
Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Illinois CancerCare-Dixon
Dixon, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Valley Radiation Oncology
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Cancer Care Specialists of Illinois-Swansea
Swansea, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
The Carle Foundation Hospital
Urbana, Illinois, United States
Rush-Copley Healthcare Center
Yorkville, Illinois, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Mary Greeley Medical Center
Ames, Iowa, United States
McFarland Clinic PC - Ames
Ames, Iowa, United States
McFarland Clinic PC-Boone
Boone, Iowa, United States
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, United States
Mercy Hospital
Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States
Broadlawns Medical Center
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
McFarland Clinic PC-Trinity Cancer Center
Fort Dodge, Iowa, United States
Trinity Regional Medical Center
Fort Dodge, Iowa, United States
McFarland Clinic PC-Jefferson
Jefferson, Iowa, United States
McFarland Clinic PC-Marshalltown
Marshalltown, Iowa, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, United States
Methodist West Hospital
West Des Moines, Iowa, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Lafayette Family Cancer Center-EMMC
Brewer, Maine, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
UM Saint Joseph Medical Center
Towson, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Steward Saint Elizabeth's Medical Center
Brighton, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Milford, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center at South Shore
South Weymouth, Massachusetts, United States
Hickman Cancer Center
Adrian, Michigan, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Bronson Battle Creek
Battle Creek, Michigan, United States
McLaren Cancer Institute-Bay City
Bay City, Michigan, United States
IHA Hematology Oncology Consultants-Brighton
Brighton, Michigan, United States
Saint Joseph Mercy Brighton
Brighton, Michigan, United States
IHA Hematology Oncology Consultants-Canton
Canton, Michigan, United States
Saint Joseph Mercy Canton
Canton, Michigan, United States
Caro Cancer Center
Caro, Michigan, United States
IHA Hematology Oncology Consultants-Chelsea
Chelsea, Michigan, United States
Saint Joseph Mercy Chelsea
Chelsea, Michigan, United States
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, United States
McLaren Cancer Institute-Clarkston
Clarkston, Michigan, United States
Newland Medical Associates-Clarkston
Clarkston, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Ascension Saint John Hospital
Detroit, Michigan, United States
Great Lakes Cancer Management Specialists-Doctors Park
East China Township, Michigan, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, United States
Genesee Hematology Oncology PC
Flint, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
McLaren Cancer Institute-Flint
Flint, Michigan, United States
Singh and Arora Hematology Oncology PC
Flint, Michigan, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
Academic Hematology Oncology Specialists
Grosse Pointe Woods, Michigan, United States
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, United States
Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
McLaren-Greater Lansing
Lansing, Michigan, United States
Mid-Michigan Physicians-Lansing
Lansing, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan, United States
Hope Cancer Clinic
Livonia, Michigan, United States
Saint Mary Mercy Hospital
Livonia, Michigan, United States
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan, United States
Michigan Breast Specialists-Macomb Township
Macomb, Michigan, United States
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan, United States
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, United States
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, United States
McLaren Cancer Institute-Central Michigan
Mount Pleasant, Michigan, United States
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan, United States
21st Century Oncology-Pontiac
Pontiac, Michigan, United States
Hope Cancer Center
Pontiac, Michigan, United States
Newland Medical Associates-Pontiac
Pontiac, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
McLaren-Port Huron
Port Huron, Michigan, United States
Spectrum Health Reed City Hospital
Reed City, Michigan, United States
Great Lakes Cancer Management Specialists-Rochester Hills
Rochester Hills, Michigan, United States
Ascension Saint Mary's Hospital
Saginaw, Michigan, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan, United States
Ascension Saint Joseph Hospital
Tawas City, Michigan, United States
Advanced Breast Care Center PLLC
Warren, Michigan, United States
Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, Michigan, United States
Macomb Hematology Oncology PC
Warren, Michigan, United States
Michigan Breast Specialists-Warren
Warren, Michigan, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States
Huron Gastroenterology PC
Ypsilanti, Michigan, United States
IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti, Michigan, United States
Riverwood Healthcare Center
Aitkin, Minnesota, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Cambridge Medical Center
Cambridge, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States
Miller-Dwan Hospital
Duluth, Minnesota, United States
Fairview-Southdale Hospital
Edina, Minnesota, United States
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, United States
Essentia Health - Fosston
Fosston, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States
Fairview Maple Grove Medical Center
Maple Grove, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Health Partners Inc
Minneapolis, Minnesota, United States
Monticello Cancer Center
Monticello, Minnesota, United States
New Ulm Medical Center
New Ulm, Minnesota, United States
Essentia Health - Park Rapids
Park Rapids, Minnesota, United States
Fairview Northland Medical Center
Princeton, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Essentia Health Sandstone
Sandstone, Minnesota, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States
Sanford Cancer Center Worthington
Worthington, Minnesota, United States
Fairview Lakes Medical Center
Wyoming, Minnesota, United States
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, United States
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Southeast Cancer Center
Cape Girardeau, Missouri, United States
Saint Luke's Hospital
Chesterfield, Missouri, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States
Parkland Health Center - Farmington
Farmington, Missouri, United States
Capital Region Southwest Campus
Jefferson City, Missouri, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mercy Hospital South
St Louis, Missouri, United States
Siteman Cancer Center-South County
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, United States
Mercy Hospital Washington
Washington, Missouri, United States
Community Hospital of Anaconda
Anaconda, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
Community Medical Hospital
Missoula, Montana, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, United States
Las Vegas Cancer Center-Henderson
Henderson, Nevada, United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, United States
Desert West Surgery
Las Vegas, Nevada, United States
OptumCare Cancer Care at Oakey
Las Vegas, Nevada, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Hope Cancer Care of Nevada
Las Vegas, Nevada, United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, United States
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, United States
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, United States
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada, United States
Renown Regional Medical Center
Reno, Nevada, United States
Radiation Oncology Associates
Reno, Nevada, United States
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, United States
New Hampshire Oncology Hematology PA-Hooksett
Hooksett, New Hampshire, United States
The Dana-Farber Cancer Institute at Londonderry
Londonderry, New Hampshire, United States
AtlantiCare Health Park-Cape May Court House
Cape May Court House, New Jersey, United States
AtlantiCare Surgery Center
Egg Harbor, New Jersey, United States
Lovelace Medical Center-Saint Joseph Square
Albuquerque, New Mexico, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, United States
Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho, New Mexico, United States
Christus Saint Vincent Regional Cancer Center
Santa Fe, New Mexico, United States
Hematology Oncology Associates of Central New York-Auburn
Auburn, New York, United States
Northwell Health Imbert Cancer Center
Bay Shore, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, United States
Glens Falls Hospital
Glens Falls, New York, United States
Northwell Health Cancer Institute at Huntington
Greenlawn, New York, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Hematology Oncology Associates of Central New York-Onondaga Hill
Syracuse, New York, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, United States
Novant Health Oncology Specialists-Kernersville
Kernersville, North Carolina, United States
Novant Health Oncology Specialists-Mount Airy
Mount Airy, North Carolina, United States
CarolinaEast Medical Center
New Bern, North Carolina, United States
CarolinaEast Oncology and Hematology Associates
New Bern, North Carolina, United States
Novant Health Oncology Specialists-Statesville
Statesville, North Carolina, United States
Novant Health Oncology Specialists-Davidson County
Thomasville, North Carolina, United States
Novant Health Oncology Specialists-Wilkesboro
Wilkesboro, North Carolina, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States
Novant Health Oncology Specialists
Winston-Salem, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States
Sanford South University Medical Center
Fargo, North Dakota, United States
Sanford Medical Center Fargo
Fargo, North Dakota, United States
Sanford Broadway Medical Center
Fargo, North Dakota, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
Altru Cancer Center
Grand Forks, North Dakota, United States
Essentia Health - Jamestown Clinic
Jamestown, North Dakota, United States
Strecker Cancer Center-Belpre
Belpre, Ohio, United States
Mercy Medical Center
Canton, Ohio, United States
Mount Carmel East Hospital
Columbus, Ohio, United States
Grant Medical Center
Columbus, Ohio, United States
The Mark H Zangmeister Center
Columbus, Ohio, United States
Mount Carmel Health Center West
Columbus, Ohio, United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Mount Carmel Grove City Hospital
Grove City, Ohio, United States
Marietta Memorial Hospital
Marietta, Ohio, United States
Mercy Health Perrysburg Cancer Center
Perrysburg, Ohio, United States
Mercy Saint Anne Hospital
Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States
Saint Ann's Hospital
Westerville, Ohio, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon, United States
Saint Charles Health System
Bend, Oregon, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, United States
Bay Area Hospital
Coos Bay, Oregon, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Saint Alphonsus Medical Center-Ontario
Ontario, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Saint Charles Health System-Redmond
Redmond, Oregon, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Pocono Medical Center
East Stroudsburg, Pennsylvania, United States
Ephrata Cancer Center
Ephrata, Pennsylvania, United States
Ephrata Community Hospital
Ephrata, Pennsylvania, United States
Adams Cancer Center
Gettysburg, Pennsylvania, United States
Cherry Tree Cancer Center
Hanover, Pennsylvania, United States
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, United States
Sechler Family Cancer Center
Lebanon, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, United States
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, United States
Community Medical Center
Scranton, Pennsylvania, United States
Geisinger Medical Oncology-Selinsgrove
Selinsgrove, Pennsylvania, United States
Geisinger Medical Group
State College, Pennsylvania, United States
Reading Hospital
West Reading, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
UPMC Susquehanna
Williamsport, Pennsylvania, United States
WellSpan Health-York Cancer Center
York, Pennsylvania, United States
WellSpan Health-York Hospital
York, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Lexington Medical Center
West Columbia, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
Farmington Health Center
Farmington, Utah, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
South Jordan Health Center
South Jordan, Utah, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, United States
University of Vermont Medical Center
Burlington, Vermont, United States
University of Vermont and State Agricultural College
Burlington, Vermont, United States
Centra Lynchburg Hematology-Oncology Clinic Inc
Lynchburg, Virginia, United States
Sovah Health Martinsville
Martinsville, Virginia, United States
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, United States
Bon Secours DePaul Medical Center
Norfolk, Virginia, United States
Bon Secours Saint Mary's Hospital
Richmond, Virginia, United States
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
VCU Community Memorial Health Center
South Hill, Virginia, United States
Bon Secours Health Center at Harbour View
Suffolk, Virginia, United States
Shenandoah Oncology PC
Winchester, Virginia, United States
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Providence Regional Cancer System-Lacey
Lacey, Washington, United States
PeaceHealth Saint John Medical Center
Longview, Washington, United States
Valley Medical Center
Renton, Washington, United States
Pacific Gynecology Specialists
Seattle, Washington, United States
Swedish Medical Center-Ballard Campus
Seattle, Washington, United States
Kaiser Permanente Washington
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
Swedish Medical Center-Cherry Hill
Seattle, Washington, United States
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, United States
Providence Regional Cancer System-Shelton
Shelton, Washington, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States
Providence Regional Cancer System-Yelm
Yelm, Washington, United States
Duluth Clinic Ashland
Ashland, Wisconsin, United States
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Marshfield Clinic - Ladysmith Center
Ladysmith, Wisconsin, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States
Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin, United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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NCI-2017-01596
Identifier Type: REGISTRY
Identifier Source: secondary_id
A171601
Identifier Type: -
Identifier Source: org_study_id