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Testing the Effects of Palbociclib and Fulvestrant or Letrozole for Patients 70 years of Age and Older with Metastatic Breast Cancer

Trial Status: Closed to Accrual

This phase II trial studies the side effects and how well palbociclib and letrozole or fulvestrant works in treating patients aged 70 and older with estrogen receptor positive, HER2 negative breast cancer that has spread to other places in the body (metastatic). 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. It is not yet known if giving palbociclib and letrozole or fulvestrant may work better in treating patients aged 70 and older with breast cancer.

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)

Alaska

Anchorage
Alaska Breast Care and Surgery LLC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Alaska Oncology and Hematology LLC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Alaska Women's Cancer Care
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Associates in Radiation Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Oncology Centre
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Radiation Therapy Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Katmai Oncology Group
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Providence Alaska Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871

Arizona

Kingman
Kingman Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 773-702-9171

California

Arroyo Grande
PCR Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 818-847-4793
Corona
City of Hope Corona
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-826-4673
Duarte
City of Hope Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-826-4673
Lancaster
City of Hope Antelope Valley
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-826-4673
Mission Hills
City of Hope Mission Hills
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-826-4673
Orange
Saint Joseph Hospital - Orange
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 714-734-6220
Sacramento
University of California Davis Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 916-734-3089
Santa Clarita
City of Hope - Santa Clarita
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-826-4673
South Pasadena
City of Hope South Pasadena
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-826-4673
Upland
City of Hope Upland
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-826-4673
West Covina
City of Hope West Covina
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-826-4673

Colorado

Denver
Cancer Center of Colorado at Sloan's Lake
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 303-777-2663
SCL Health Saint Joseph Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 303-777-2663
Lafayette
Good Samaritan Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 303-673-1622
Wheat Ridge
SCL Health Lutheran Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 303-777-2663

Delaware

Lewes
Beebe Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 302-645-3770
Newark
Christiana Care Health System-Christiana Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 302-623-4450
Delaware Clinical and Laboratory Physicians PA
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 302-623-4450
Helen F Graham Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 302-623-4450
Medical Oncology Hematology Consultants PA
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 302-623-4450
Rehoboth Beach
Beebe Health Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 302-645-3100
Seaford
Nanticoke Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 302-645-3100
Wilmington
Christiana Care Health System-Wilmington Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 302-623-4450

District of Columbia

Washington
Sibley Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 202-243-2373

Florida

Lakeland
The Watson Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 863-680-7780

Hawaii

Aiea
Hawaii Cancer Care - Savio
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-539-2273
Pali Momi Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-486-6000
Queen's Cancer Center - Pearlridge
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-487-7447
The Cancer Center of Hawaii-Pali Momi
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-678-9000
Honolulu
Hawaii Cancer Care Inc-Liliha
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-536-4888
Hawaii Cancer Care Inc-POB II
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-524-6115
Island Urology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-536-2306
Kapiolani Medical Center for Women and Children
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-983-6090
Kuakini Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-547-9816
Queen's Cancer Cenrer - POB I
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-532-0315
Queen's Cancer Center - Kuakini
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-531-8521
Queen's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-545-8548
Straub Clinic and Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-522-4333
The Cancer Center of Hawaii-Liliha
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-547-6881
University of Hawaii Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-586-2979
Lihue
Wilcox Memorial Hospital and Kauai Medical Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-535-7960

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Mountain States Tumor Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 208-381-2774
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Coeur D'Alene
Kootenai Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Emmett
Walter Knox Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Fruitland
Saint Luke's Mountain States Tumor Institute - Fruitland
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 208-381-8059
Meridian
Idaho Urologic Institute-Meridian
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Mountain States Tumor Institute - Meridian
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 208-381-8059
Nampa
Saint Alphonsus Medical Center-Nampa
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Mountain States Tumor Institute - Nampa
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 208-381-8059
Post Falls
Kootenai Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Sandpoint
Kootenai Cancer Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Twin Falls
Saint Luke's Mountain States Tumor Institute-Twin Falls
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 208-381-8059

Illinois

Aurora
Rush - Copley Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 630-978-6212
Bloomington
Illinois CancerCare-Bloomington
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Canton
Illinois CancerCare-Canton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Carthage
Illinois CancerCare-Carthage
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Centralia
Centralia Oncology Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4740
Chicago
Northwestern University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 312-695-1301
University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 773-702-8222
Danville
Carle on Vermilion
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4740
Decatur Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4740
Dixon
Illinois CancerCare-Dixon
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 815-285-7800
Effingham
Carle Physician Group-Effingham
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Crossroads Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4740
Eureka
Illinois CancerCare-Eureka
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Galesburg
Illinois CancerCare-Galesburg
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Western Illinois Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-344-2831
Joliet
Joliet Oncology-Hematology Associates Limited
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 815-730-3098
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Macomb
Illinois CancerCare-Macomb
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Mount Vernon
Good Samaritan Regional Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 618-242-4600
New Lenox
UC Comprehensive Cancer Center at Silver Cross
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 773-702-8222
O'Fallon
Cancer Care Center of O'Fallon
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4740
Orland Park
University of Chicago Medicine-Orland Park
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 773-702-8222
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Pekin
Illinois CancerCare-Pekin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Peoria
Illinois CancerCare-Peoria
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Methodist Medical Center of Illinois
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Peru
Illinois CancerCare-Peru
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Valley Radiation Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 815-664-4141
Princeton
Illinois CancerCare-Princeton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Springfield
Memorial Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-788-3528
Southern Illinois University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-444-7541
Urbana
Carle Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
The Carle Foundation Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Yorkville
Rush-Copley Healthcare Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 630-978-6212

Indiana

South Bend
Memorial Hospital of South Bend
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-284-7370

Iowa

Ames
Mary Greeley Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-956-4132
McFarland Clinic PC - Ames
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-239-4734
Boone
McFarland Clinic PC-Boone
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-956-4132
Cedar Rapids
Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 319-365-4673
Oncology Associates at Mercy Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 319-363-2690
Physicians' Clinic of Iowa PC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 319-297-2900
Des Moines
Broadlawns Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-282-2200
Iowa Lutheran Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-241-8704
Iowa Methodist Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-282-2921
Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-956-4132
Trinity Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-574-8302
Jefferson
McFarland Clinic PC-Jefferson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-956-4132
Marshalltown
McFarland Clinic PC-Marshalltown
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-956-4132
Sioux City
Siouxland Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 712-252-9326
West Des Moines
Methodist West Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-343-1000

Kansas

Lawrence
Lawrence Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Wichita
Cancer Center of Kansas - Wichita
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Cancer Center of Kansas-Wichita Medical Arts Tower
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374

Louisiana

New Orleans
Ochsner Medical Center Jefferson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 504-703-8712

Maine

Bangor
Eastern Maine Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 207-973-4274
Brewer
Lafayette Family Cancer Center-EMMC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-987-3005

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 410-955-8804
Bethesda
Walter Reed National Military Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 301-319-2100
Towson
UM Saint Joseph Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 410-337-4569

Massachusetts

Boston
Brigham and Women's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 617-724-5200
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-442-3324
Tufts Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 617-636-5000
Brighton
Steward Saint Elizabeth's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 617-789-2903
Milford
Dana-Farber / Brigham and Women's Cancer Center at Milford Regional
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-332-4294
South Weymouth
Dana-Farber / Brigham and Women's Cancer Center at South Shore
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 781-624-5000

Michigan

Adrian
Hickman Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 517-265-0116
Ann Arbor
Saint Joseph Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Battle Creek
Bronson Battle Creek
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Bay City
McLaren Cancer Institute-Bay City
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Brighton
IHA Hematology Oncology Consultants-Brighton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Brighton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Canton
IHA Hematology Oncology Consultants-Canton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Canton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Caro
Caro Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Chelsea
IHA Hematology Oncology Consultants-Chelsea
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Chelsea
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Clarkston
Hematology Oncology Consultants-Clarkston
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
McLaren Cancer Institute-Clarkston
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Newland Medical Associates-Clarkston
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Detroit
Ascension Saint John Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
East China
Great Lakes Cancer Management Specialists-Doctors Park
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Farmington Hills
Weisberg Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Flint
Genesee Cancer and Blood Disease Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Genesee Hematology Oncology PC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Genesys Hurley Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Hurley Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
McLaren Cancer Institute-Flint
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Singh and Arora Hematology Oncology PC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Grand Rapids
Spectrum Health at Butterworth Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Grosse Pointe Woods
Academic Hematology Oncology Specialists
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Michigan Breast Specialists-Grosse Pointe Woods
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Kalamazoo
Borgess Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Bronson Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
West Michigan Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Lansing
McLaren-Greater Lansing
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Mid-Michigan Physicians-Lansing
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Sparrow Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Lapeer
McLaren Cancer Institute-Lapeer Region
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Livonia
Hope Cancer Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Saint Mary Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Macomb Township
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Michigan Breast Specialists-Macomb Township
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Marlette
Saint Mary's Oncology / Hematology Associates of Marlette
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Monroe
Toledo Clinic Cancer Centers-Monroe
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-444-3561
Mount Clemens
McLaren Cancer Institute-Macomb
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Mount Pleasant
McLaren Cancer Institute-Central Michigan
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Petoskey
McLaren Cancer Institute-Northern Michigan
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Pontiac
21st Century Oncology-Pontiac
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Hope Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Newland Medical Associates-Pontiac
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Oakland
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Port Huron
McLaren-Port Huron
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Reed City
Spectrum Health Reed City Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Rochester Hills
Great Lakes Cancer Management Specialists-Rochester Hills
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Saginaw
Ascension Saint Mary's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Oncology Hematology Associates of Saginaw Valley PC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Marie Yeager Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Tawas City
Ascension Saint Joseph Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Warren
Advanced Breast Care Center PLLC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Great Lakes Cancer Management Specialists-Macomb Professional Building
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Macomb Hematology Oncology PC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Michigan Breast Specialists-Warren
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Saint John Macomb-Oakland Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
West Branch
Saint Mary's Oncology / Hematology Associates of West Branch
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Wyoming
Metro Health Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Ypsilanti
Huron Gastroenterology PC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
IHA Hematology Oncology Consultants-Ann Arbor
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671

Minnesota

Aitkin
Riverwood Healthcare Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Bemidji
Sanford Joe Lueken Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-333-5000
Brainerd
Essentia Health Saint Joseph's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Burnsville
Fairview Ridges Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Cambridge
Cambridge Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Coon Rapids
Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Deer River
Essentia Health - Deer River Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Detroit Lakes
Essentia Health Saint Mary's - Detroit Lakes Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Duluth
Essentia Health Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Essentia Health Saint Mary's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Miller-Dwan Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Edina
Fairview Southdale Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Fergus Falls
Lake Region Healthcare Corporation-Cancer Care
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Fosston
Essentia Health - Fosston
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Fridley
Unity Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Hibbing
Essentia Health Hibbing Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Saint John's Hospital - Healtheast
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Minneapolis
Abbott-Northwestern Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Health Partners Inc
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Hennepin County Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Monticello
Monticello Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
New Ulm
New Ulm Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Park Rapids
Essentia Health - Park Rapids
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Princeton
Fairview Northland Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Robbinsdale
North Memorial Medical Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Saint Cloud
Coborn Cancer Center at Saint Cloud Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-229-4907
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Saint Paul
Regions Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
United Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Sandstone
Essentia Health Sandstone
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Shakopee
Saint Francis Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Stillwater
Lakeview Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Thief River Falls
Sanford Thief River Falls Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 605-312-3320
Virginia
Essentia Health Virginia Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Waconia
Ridgeview Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Willmar
Rice Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Worthington
Sanford Cancer Center Worthington
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 605-312-3320
Wyoming
Fairview Lakes Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517

Missouri

Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-251-7058
Bonne Terre
Parkland Health Center-Bonne Terre
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569
Cape Girardeau
Saint Francis Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Southeast Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-651-5550
Chesterfield
Saint Luke's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-205-6936
Columbia
University of Missouri - Ellis Fischel
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-882-7440
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-600-3606
Farmington
Parkland Health Center - Farmington
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569
Jefferson City
Capital Region Southwest Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-632-4814
Saint Louis
Mercy Hospital Saint Louis
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-251-7066
Mercy Hospital South
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Missouri Baptist Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569
Saint Louis Cancer and Breast Institute-South City
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-353-1870
Siteman Cancer Center at Christian Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-600-3606
Siteman Cancer Center-South County
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-600-3606
Washington University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-600-3606
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-600-3606
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569
Springfield
Mercy Hospital Springfield
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-269-4520
Sullivan
Missouri Baptist Sullivan Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569
Washington
Mercy Hospital Washington
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 636-390-1600

Montana

Anaconda
Community Hospital of Anaconda
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Billings
Billings Clinic Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-996-2663
Bozeman
Bozeman Deaconess Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Kalispell
Kalispell Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Missoula
Community Medical Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Saint Patrick Hospital - Community Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-327-3118

Nebraska

Omaha
Nebraska Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 402-354-5144

Nevada

Henderson
Comprehensive Cancer Centers of Nevada - Henderson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Cancer Center-Henderson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at Seven Hills
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas
Comprehensive Cancer Centers of Nevada
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Central Valley
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Northwest
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Town Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Summerlin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Desert West Surgery
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Hope Cancer Care of Nevada
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Cancer Center-Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at Fort Apache
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at MountainView
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at Oakey
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Radiation Oncology Centers of Nevada Central
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Radiation Oncology Centers of Nevada Southeast
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
University Medical Center of Southern Nevada
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Pahrump
Hope Cancer Care of Nevada-Pahrump
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Reno
Radiation Oncology Associates
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Renown Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013

New Hampshire

Concord
New Hampshire Oncology Hematology PA-Concord
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 603-224-2556
Hooksett
New Hampshire Oncology Hematology PA-Hooksett
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-339-6484
Londonderry
The Dana-Farber Cancer Institute at Londonderry
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 773-702-9171

New Jersey

Cape May Court House
AtlantiCare Health Park-Cape May Court House
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-369-2427
Egg Harbor Township
AtlantiCare Surgery Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 609-748-7200

New Mexico

Albuquerque
Lovelace Medical Center-Saint Joseph Square
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 505-272-0530
Presbyterian Kaseman Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 505-559-6113
University of New Mexico Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 505-925-0366
Rio Rancho
Presbyterian Rust Medical Center / Jorgensen Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 505-559-6113
Santa Fe
Christus Saint Vincent Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 505-913-8933

New York

Auburn
Hematology Oncology Associates of Central New York-Auburn
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 315-472-7504
Bay Shore
Northwell Health Imbert Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 516-734-8896
Bronx
Montefiore Medical Center - Moses Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 718-379-6866
Montefiore Medical Center-Einstein Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 718-379-6866
Montefiore Medical Center-Weiler Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 718-379-6866
Buffalo
Roswell Park Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-767-9355
East Syracuse
Hematology Oncology Associates of Central New York-East Syracuse
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 315-472-7504
Glens Falls
Glens Falls Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 518-926-6700
Greenlawn
Northwell Health Cancer Institute at Huntington
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 516-734-8896
Lake Success
Northwell Health / Center for Advanced Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 516-734-8896
Stony Brook
Stony Brook University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-862-2215
Syracuse
Hematology Oncology Associates of Central New York-Onondaga Hill
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 315-472-7504

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-668-0683
Clinton
Southeastern Medical Oncology Center-Clinton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 919-587-9084
Durham
Duke University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-275-3853
Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 919-587-9084
Wayne Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 919-731-6687
Jacksonville
Southeastern Medical Oncology Center-Jacksonville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 910-587-9084
Kernersville
Novant Health Oncology Specialists-Kernersville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 336-718-8335
Mount Airy
Novant Health Oncology Specialists-Mount Airy
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 336-718-8335
New Bern
CarolinaEast Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 252-634-6589
CarolinaEast Oncology and Hematology Associates
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 773-702-9171
Stateville
Novant Health Oncology Specialists-Statesville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 336-718-8335
Thomasville
Novant Health Oncology Specialists-Davidson County
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 336-718-8335
Wilkesboro
Novant Health Oncology Specialists-Wilkesboro
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 336-718-8335
Winston-Salem
Novant Health Forsyth Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 336-718-8335
Novant Health Oncology Specialists
Status: ACTIVE
Contact: Site Public Contact
Phone: 336-718-8335
Wake Forest University Health Sciences
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 701-323-5760
Fargo
Essentia Health Cancer Center-South University Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Sanford Broadway Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 701-323-5760
Sanford Medical Center Fargo
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-437-4010
Sanford Roger Maris Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 701-234-6161
Sanford South University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 701-234-6161
Grand Forks
Altru Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 701-780-6520
Jamestown
Essentia Health - Jamestown Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308

Ohio

Belpre
Strecker Cancer Center-Belpre
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-523-3977
Canton
Mercy Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-293-4673
Columbus
Grant Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-566-4475
Mount Carmel East Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Mount Carmel Health Center West
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-234-5433
The Mark H Zangmeister Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Delaware
Delaware Health Center-Grady Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 740-615-0227
Grady Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 740-615-2403
Grove City
Mount Carmel Grove City Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-779-7585
Marietta
Marietta Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-523-3977
Perrysburg
Mercy Health Perrysburg Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 419-479-5605
Toledo
Mercy Saint Anne Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 419-407-1160
Toledo Clinic Cancer Centers-Toledo
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-444-3561
Westerville
Saint Ann's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-234-5433

Oklahoma

Oklahoma City
Mercy Hospital Oklahoma City
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 405-752-3402

Oregon

Baker City
Saint Alphonsus Medical Center-Baker City
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Bend
Saint Charles Health System
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 541-706-2909
Clackamas
Clackamas Radiation Oncology Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Providence Cancer Institute Clackamas Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Coos Bay
Bay Area Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 541-269-8392
Newberg
Providence Newberg Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Ontario
Saint Alphonsus Medical Center-Ontario
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Portland
Providence Portland Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Providence Saint Vincent Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Redmond
Saint Charles Health System-Redmond
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 541-706-2909

Pennsylvania

Allentown
Lehigh Valley Hospital-Cedar Crest
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Bethlehem
Lehigh Valley Hospital - Muhlenberg
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Chadds Ford
Christiana Care Health System-Concord Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 302-623-4450
Danville
Geisinger Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-271-5251
East Stroudsburg
Pocono Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-422-1700
Ephrata
Ephrata Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 717-721-4840
Ephrata Community Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 773-702-9171
Gettysburg
Adams Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-441-7957
Hanover
Cherry Tree Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-441-7957
Harrisburg
UPMC Pinnacle Cancer Center / Community Osteopathic Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 717-724-6765
UPMC Pinnacle Harrisburg
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 773-702-9171
Hazleton
Geisinger Medical Center-Cancer Center Hazleton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-459-2901
Lehigh Valley Hospital-Hazleton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-501-1242
Lebanon
Sechler Family Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 717-741-8303
Lewisburg
Geisinger Medical Oncology-Lewisburg
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-374-8555
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 412-647-8073
Pottsville
Geisinger Cancer Services-Pottsville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-275-6401
Sayre
Guthrie Medical Group PC-Robert Packer Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-836-0388
Scranton
Community Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-703-4768
Selinsgrove
Geisinger Medical Oncology-Selinsgrove
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-374-8555
State College
Geisinger Medical Group
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-271-5251
West Reading
Reading Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 610-988-9323
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-271-5251
Williamsport
UPMC Susquehanna
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-598-4282
York
WellSpan Health-York Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-441-7957
WellSpan Health-York Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-441-7957

South Carolina

Charleston
Medical University of South Carolina
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 843-792-9321
West Columbia
Lexington Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 803-936-8050

South Dakota

Rapid City
Rapid City Regional Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 605-716-3982
Sioux Falls
Sanford Cancer Center Oncology Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 605-312-3320

Utah

Farmington
Farmington Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-424-2100
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-424-2100
South Jordan
South Jordan Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-424-2100

Vermont

Berlin
Central Vermont Medical Center / National Life Cancer Treatment
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 802-225-5400
Burlington
University of Vermont Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 802-656-4101
Email: rpo@uvm.edu
University of Vermont and State Agricultural College
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 802-656-8990
Email: rpo@uvm.edu

Virginia

Lynchburg
Centra Lynchburg Hematology-Oncology Clinic Inc
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 434-200-5925
Martinsville
Sovah Health Martinsville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 276-666-7489
Mechanicsville
Bon Secours Memorial Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 804-893-8611
Midlothian
Bon Secours Saint Francis Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 804-893-8611
Norfolk
Bon Secours DePaul Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 804-893-8611
Richmond
Bon Secours Cancer Institute at Reynolds Crossing
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 804-893-8611
Bon Secours Saint Mary's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 804-893-8611
VCU Massey Cancer Center at Stony Point
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 804-628-1939
Virginia Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 804-287-3000
Virginia Commonwealth University / Massey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 804-628-1914
South Hill
VCU Community Memorial Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 434-774-2442
Suffolk
Bon Secours Health Center at Harbour View
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 757-398-4234
Winchester
Shenandoah Oncology PC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 540-662-1108

Washington

Aberdeen
Providence Regional Cancer System-Aberdeen
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-412-8958
Bellingham
PeaceHealth Saint Joseph Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-715-4133
Centralia
Providence Regional Cancer System-Centralia
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-412-8958
Edmonds
Swedish Cancer Institute-Edmonds
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Everett
Providence Regional Cancer Partnership
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 425-261-3529
Issaquah
Swedish Cancer Institute-Issaquah
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Kennewick
Kadlec Clinic Hematology and Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 509-783-4637
Lacey
Providence Regional Cancer System-Lacey
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-412-8958
Longview
PeaceHealth Saint John Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-514-2016
Renton
Valley Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 425-228-3440
Seattle
Kaiser Permanente Washington
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Pacific Gynecology Specialists
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-Ballard Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-Cherry Hill
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-First Hill
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Sedro-Woolley
PeaceHealth United General Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-788-8240
Shelton
Providence Regional Cancer System-Shelton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-412-8958
Vancouver
PeaceHealth Southwest Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-514-3940
Walla Walla
Providence Saint Mary Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 509-897-5993
Yelm
Providence Regional Cancer System-Yelm
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-412-8958

Wisconsin

Ashland
Duluth Clinic Ashland
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Northwest Wisconsin Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Chippewa Falls
Marshfield Clinic-Chippewa Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581
Eau Claire
Marshfield Medical Center-EC Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581
La Crosse
Gundersen Lutheran Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 608-775-2385
Ladysmith
Marshfield Clinic - Ladysmith Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581
Marshfield
Marshfield Medical Center-Marshfield
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581
Minocqua
Marshfield Clinic-Minocqua Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581
New Richmond
Cancer Center of Western Wisconsin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Rice Lake
Marshfield Medical Center-Rice Lake
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581
Stevens Point
Marshfield Clinic Stevens Point Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581
Wausau
Marshfield Clinic-Wausau Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581
Weston
Marshfield Clinic - Weston Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581
Wisconsin Rapids
Marshfield Clinic - Wisconsin Rapids Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581

PRIMARY OBJECTIVE:

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 Was It Worth It (WIWI) Questionnaire and 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.

CORRELATIVE SCIENCE OBJECTIVES:

I. To explore the association between baseline chronic inflammatory mediator levels and development of adverse events.

II. To explore the association between baseline chronic inflammatory mediator levels and treatment modification.

III. To explore the association between baseline chronic inflammatory mediator levels and baseline physical function as assessed by the cancer-specific geriatric assessment.

IV. To explore the association between baseline chronic inflammatory mediator levels and decline in physical function as assessed by the cancer-specific geriatric assessment.

V. To explore the correlation between inherited single nucleotide polymorphisms (SNPs) in cell cycle pathway genes and in genes that metabolize palbociclib and treatment efficacy and toxicity (clinical outcomes) in elderly patients undergoing combined endocrine therapy plus palbociclib for estrogen receptor positive, HER2 negative metastatic breast cancer.

VI. To explore whether genes in CYP19A, CYP2A6 and ESR1 will also correlate with treatment efficacy and toxicity (clinical outcomes) in elderly patients undergoing combined endocrine therapy plus palbociclib for estrogen receptor positive, HER2 negative metastatic breast cancer.

VII. To refine a population pharmacokinetic model using nonlinear mixed effects modeling (NONMEM) for palbociclib based on that of Sun and Wang (European Society for Medical Oncology [ESMO] poster presentation 462P 2014) taking account of relevant intrinsic and extrinsic factors.

VIII. To determine the intrapatient and interpatient variability of palbociclib exposure (area under the curve [AUC]) in older breast cancer patients receiving palbociclib plus letrozole/fulvestrant.

IX. To explore the exposure (AUC/maximum concentration [Cmax]) toxicity (neutropenia, thrombocytopenia) relationship for palbociclib when combined with letrozole/fulvestrant in older breast cancer patients.

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 cycle 1 and on day 1 of subsequent cycles per Doctor of Medicine (MD) discretion. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Alliance for Clinical Trials in Oncology

Principal Investigator
Mina S. Sedrak

  • Primary ID A171601
  • Secondary IDs NCI-2017-01596
  • Clinicaltrials.gov ID NCT03633331