Palbociclib and Letrozole or Fulvestrant in Treating Patients Aged 70 and Older with Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer

Status: Active

Description

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.

Eligibility Criteria

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 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)

Locations & Contacts

Alaska

Anchorage
Alaska Breast Care and Surgery LLC
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Alaska Oncology and Hematology LLC
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Alaska Women's Cancer Care
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Anchorage Associates in Radiation Medicine
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Anchorage Oncology Centre
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Anchorage Radiation Therapy Center
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Katmai Oncology Group
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Providence Alaska Medical Center
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org

Arizona

Kingman
Kingman Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 773-702-9171
Email: protocols@AllianceNCTN.org

California

Arroyo Grande
PCR Oncology
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 818-847-4793
Email: Najee.Boucher@providence.org
Corona
City of Hope Corona
Status: Active
Contact: Site Public Contact
Phone: 800-826-4673
Email: becomingapatient@coh.org
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-826-4673
Email: becomingapatient@coh.org
Lancaster
City of Hope Antelope Valley
Status: Active
Contact: Site Public Contact
Phone: 800-826-4673
Email: becomingapatient@coh.org
Mission Hills
City of Hope Mission Hills
Status: Active
Contact: Site Public Contact
Phone: 800-826-4673
Email: becomingapatient@coh.org
Orange
Saint Joseph Hospital - Orange
Status: Active
Contact: Site Public Contact
Phone: 714-734-6220
Santa Clarita
City of Hope - Santa Clarita
Status: Active
Contact: Site Public Contact
Phone: 800-826-4673
Email: becomingapatient@coh.org
South Pasadena
City of Hope South Pasadena
Status: Active
Contact: Site Public Contact
Phone: 800-826-4673
Email: becomingapatient@coh.org
Upland
City of Hope Upland
Status: Active
Contact: Site Public Contact
Phone: 800-826-4673
Email: becomingapatient@coh.org
West Covina
City of Hope West Covina
Status: Active
Contact: Site Public Contact
Phone: 800-826-4673
Email: becomingapatient@coh.org

Colorado

Denver
Cancer Center of Colorado at Sloan's Lake
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
SCL Health Saint Joseph Hospital
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Lafayette
Good Samaritan Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-673-1622
Wheat Ridge
SCL Health Lutheran Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org

Delaware

Lewes
Beebe Medical Center
Status: Active
Contact: Site Public Contact
Phone: 302-645-3770
Email: Dmiskin@Beebehealthcare.org
Newark
Christiana Care Health System-Christiana Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Delaware Clinical and Laboratory Physicians PA
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Helen F Graham Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Medical Oncology Hematology Consultants PA
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Rehoboth Beach
Beebe Health Campus
Status: Active
Contact: Site Public Contact
Phone: 302-645-3100
Email: Dmiskin@Beebehealthcare.org
Seaford
Nanticoke Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 302-645-3100
Email: Dmiskin@Beebehealthcare.org
Wilmington
Christiana Care Health System-Wilmington Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org

District of Columbia

Washington
Sibley Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 202-243-2373
Email: jquiver1@jhmi.edu

Florida

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

Hawaii

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

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Luke's Mountain States Tumor Institute
Status: Active
Contact: Site Public Contact
Phone: 208-381-2774
Email: eslinget@slhs.org
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Coeur D'Alene
Kootenai Medical Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Emmett
Walter Knox Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Fruitland
Saint Luke's Mountain States Tumor Institute - Fruitland
Status: Active
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org
Meridian
Idaho Urologic Institute-Meridian
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Luke's Mountain States Tumor Institute - Meridian
Status: Active
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org
Nampa
Saint Alphonsus Medical Center-Nampa
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Luke's Mountain States Tumor Institute - Nampa
Status: Active
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org
Post Falls
Kootenai Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Sandpoint
Kootenai Cancer Clinic
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Twin Falls
Saint Luke's Mountain States Tumor Institute-Twin Falls
Status: Active
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org

Illinois

Aurora
Rush - Copley Medical Center
Status: Active
Contact: Site Public Contact
Phone: 630-978-6212
Email: Cancer.Research@rushcopley.com
Bloomington
Illinois CancerCare-Bloomington
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Canton
Illinois CancerCare-Canton
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Carthage
Illinois CancerCare-Carthage
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Centralia
Centralia Oncology Clinic
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Chicago
Northwestern University
Status: Active
Contact: Site Public Contact
Phone: 312-695-1301
Email: cancer@northwestern.edu
University of Chicago Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 773-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu
Danville
Carle on Vermilion
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Decatur Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Dixon
Illinois CancerCare-Dixon
Status: Active
Contact: Site Public Contact
Phone: 815-285-7800
Effingham
Carle Physician Group-Effingham
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Crossroads Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Eureka
Illinois CancerCare-Eureka
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Galesburg
Illinois CancerCare-Galesburg
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Western Illinois Cancer Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 309-344-2831
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Macomb
Illinois CancerCare-Macomb
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Mount Vernon
Good Samaritan Regional Health Center
Status: Active
Contact: Site Public Contact
Phone: 618-242-4600
New Lenox
UC Comprehensive Cancer Center at Silver Cross
Status: Active
Contact: Site Public Contact
Phone: 773-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu
Orland Park
University of Chicago Medicine-Orland Park
Status: Active
Contact: Site Public Contact
Phone: 773-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Pekin
Illinois CancerCare-Pekin
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peoria
Illinois CancerCare-Peoria
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Methodist Medical Center of Illinois
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peru
Illinois CancerCare-Peru
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Valley Radiation Oncology
Status: Active
Contact: Site Public Contact
Phone: 815-664-4141
Princeton
Illinois CancerCare-Princeton
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Springfield
Memorial Medical Center
Status: Active
Contact: Site Public Contact
Phone: 217-788-3528
Southern Illinois University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: Active
Contact: Site Public Contact
Phone: 800-444-7541
Swansea
Cancer Care Specialists of Illinois-Swansea
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Urbana
Carle Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
The Carle Foundation Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Yorkville
Rush-Copley Healthcare Center
Status: Active
Contact: Site Public Contact
Phone: 630-978-6212
Email: Cancer.Research@rushcopley.com

Indiana

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

Iowa

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

Kansas

Lawrence
Lawrence Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Wichita
Cancer Center of Kansas - Wichita
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Cancer Center of Kansas-Wichita Medical Arts Tower
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org

Louisiana

New Orleans
Ochsner Medical Center Jefferson
Status: Active
Contact: Site Public Contact
Phone: 504-703-8712
Email: Gregory.Johnstone@ochsner.org

Maine

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

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 410-955-8804
Email: jhcccro@jhmi.edu
Bethesda
Walter Reed National Military Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 301-319-2100
Towson
UM Saint Joseph Medical Center
Status: Active
Contact: Site Public Contact
Phone: 410-337-4569
Email: patriciajohnson@catholichealth.net

Massachusetts

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

Michigan

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

Minnesota

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

Missouri

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

Montana

Anaconda
Community Hospital of Anaconda
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Billings
Billings Clinic Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Bozeman
Bozeman Deaconess Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Kalispell
Kalispell Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Missoula
Community Medical Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Saint Patrick Hospital - Community Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-327-3118
Email: amy.hanneman@providence.org

Nebraska

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

Nevada

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

New Hampshire

Concord
New Hampshire Oncology Hematology PA-Concord
Status: Active
Contact: Site Public Contact
Phone: 603-224-2556
Hooksett
New Hampshire Oncology Hematology PA-Hooksett
Status: Active
Contact: Site Public Contact
Phone: 800-339-6484
Londonderry
The Dana-Farber Cancer Institute at Londonderry
Status: Active
Contact: Site Public Contact
Phone: 773-702-9171
Email: protocols@AllianceNCTN.org

New Mexico

Albuquerque
Lovelace Medical Center-Saint Joseph Square
Status: Active
Contact: Site Public Contact
Phone: 505-272-0530
Email: AYost@nmcca.org
Presbyterian Kaseman Hospital
Status: Active
Contact: Site Public Contact
Phone: 505-559-6113
Email: WBurman@phs.org
University of New Mexico Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 505-925-0366
Email: LByatt@nmcca.org
Rio Rancho
Presbyterian Rust Medical Center / Jorgensen Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 505-559-6113
Email: WBurman@phs.org

New York

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

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu
Clinton
Southeastern Medical Oncology Center-Clinton
Status: Active
Contact: Site Public Contact
Phone: 919-587-9077
Email: ecooke@cancersmoc.com
Durham
Duke University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 888-275-3853
Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Status: Active
Contact: Site Public Contact
Phone: 919-587-9077
Email: ecooke@cancersmoc.com
Jacksonville
Southeastern Medical Oncology Center-Jacksonville
Status: Active
Contact: Site Public Contact
Phone: 910-353-0824
Email: ecooke@cancersmoc.com
Kernersville
Novant Health Oncology Specialists-Kernersville
Status: Active
Contact: Site Public Contact
Phone: 336-718-8335
Email: asmarrs@novanthealth.org
Mount Airy
Novant Health Oncology Specialists-Mount Airy
Status: Active
Contact: Site Public Contact
Phone: 336-718-8335
Email: asmarrs@novanthealth.org
New Bern
CarolinaEast Medical Center
Status: Active
Contact: Site Public Contact
Phone: 252-634-6589
Email: lharrison@carolinaeasthealth.com
CarolinaEast Oncology and Hematology Associates
Status: Active
Contact: Site Public Contact
Phone: 773-702-9171
Email: protocols@AllianceNCTN.org
Stateville
Novant Health Oncology Specialists-Statesville
Status: Active
Contact: Site Public Contact
Phone: 336-718-8335
Email: asmarrs@novanthealth.org
Thomasville
Novant Health Oncology Specialists-Davidson County
Status: Active
Contact: Site Public Contact
Phone: 336-718-8335
Email: asmarrs@novanthealth.org
Wilkesboro
Novant Health Oncology Specialists-Wilkesboro
Status: Active
Contact: Site Public Contact
Phone: 336-718-8335
Email: asmarrs@novanthealth.org
Winston-Salem
Novant Health Forsyth Medical Center
Status: Active
Contact: Site Public Contact
Phone: 336-718-8335
Email: asmarrs@novanthealth.org
Novant Health Oncology Specialists
Status: Active
Contact: Site Public Contact
Phone: 336-718-8335
Email: asmarrs@novanthealth.org
Wake Forest University Health Sciences
Status: Active
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Fargo
Essentia Health Cancer Center-South University Clinic
Status: Active
Contact: Site Public Contact
Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org
Sanford Broadway Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Sanford Medical Center Fargo
Status: Active
Contact: Site Public Contact
Phone: 800-437-4010
Sanford Roger Maris Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 701-234-6161
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Sanford South University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-234-6161
Grand Forks
Altru Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 701-780-6520
Jamestown
Essentia Health - Jamestown Clinic
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org

Ohio

Perrysburg
Mercy Health Perrysburg Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 419-479-5605
Email: pshoup@toledoclinic.com
Toledo
Mercy Saint Anne Hospital
Status: Active
Contact: Site Public Contact
Phone: 419-407-1160
Toledo Clinic Cancer Centers-Toledo
Status: Active
Contact: Site Public Contact
Phone: 800-444-3561

Oklahoma

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

Oregon

Baker City
Saint Alphonsus Medical Center-Baker City
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Bend
Saint Charles Health System
Status: Active
Contact: Site Public Contact
Phone: 541-706-2909
Email: nosall@stcharleshealthcare.org
Clackamas
Clackamas Radiation Oncology Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Providence Oncology and Hematology Care Southeast
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Coos Bay
Bay Area Hospital
Status: Active
Contact: Site Public Contact
Phone: 541-269-8392
Email: cherie.cox@bayareahospital.org
Newberg
Providence Newberg Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Ontario
Saint Alphonsus Medical Center-Ontario
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Portland
Providence Portland Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Redmond
Saint Charles Health System-Redmond
Status: Active
Contact: Site Public Contact
Phone: 541-706-2909

Pennsylvania

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

South Carolina

Charleston
Medical University of South Carolina
Status: Active
Contact: Site Public Contact
Phone: 843-792-9321
Email: hcc-clinical-trials@musc.edu
West Columbia
Lexington Medical Center
Status: Active
Contact: Site Public Contact
Phone: 803-936-8050

South Dakota

Rapid City
Rapid City Regional Hospital
Status: Active
Contact: Site Public Contact
Phone: 605-716-3982
Email: research@rcrh.org
Sioux Falls
Sanford Cancer Center Oncology Clinic
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicTrialsSF@sanfordhealth.org
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicalTrialsSF@SanfordHealth.org

Utah

Farmington
Farmington Health Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu
South Jordan
South Jordan Health Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu

Vermont

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

Virginia

Lynchburg
Centra Lynchburg Hematology-Oncology Clinic Inc
Status: Active
Contact: Site Public Contact
Phone: 434-200-5925
Email: Kevin.Patel@centrahealth.com
Martinsville
Sovah Health Martinsville
Status: Active
Contact: Site Public Contact
Phone: 276-666-7489
Email: sharon.hubbard@lpnt.net
Mechanicsville
Bon Secours Memorial Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 804-893-8611
Email: Melissa_Godsey@bshsi.org
Midlothian
Bon Secours Saint Francis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 804-893-8611
Email: Melissa_Godsey@bshsi.org
Norfolk
Bon Secours DePaul Medical Center
Status: Active
Contact: Site Public Contact
Phone: 804-893-8611
Email: Melissa_Godsey@bshsi.org
Richmond
Bon Secours Cancer Institute at Reynolds Crossing
Status: Active
Contact: Site Public Contact
Phone: 804-893-8611
Email: Melissa_godsey@bshsi.org
Bon Secours Saint Mary's Hospital
Status: Active
Contact: Site Public Contact
Phone: 804-893-8611
Email: Melissa_Godsey@bshsi.org
VCU Massey Cancer Center at Stony Point
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 804-628-1939
Email: mwellons@vcu.edu
Virginia Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 804-287-3000
Email: david.trent@comcast.net
Virginia Commonwealth University / Massey Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 804-628-1914
Email: klcampbell@vcu.edu
South Hill
VCU Community Memorial Health Center
Status: Active
Contact: Site Public Contact
Phone: 434-774-2442
Email: sherman.baker@vcuhealth.org
Suffolk
Bon Secours Health Center at Harbour View
Status: Active
Contact: Site Public Contact
Phone: 757-398-4234
Email: melissa_eckert@bshsi.org
Winchester
Shenandoah Oncology PC
Status: Active
Contact: Site Public Contact
Phone: 540-662-1108
Email: William.Houck@usoncology.com

Washington

Aberdeen
Providence Regional Cancer System-Aberdeen
Status: Active
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org
Bellingham
PeaceHealth Saint Joseph Medical Center
Status: Active
Contact: Site Public Contact
Phone: 360-715-4133
Email: mjohnson9@peacehealth.org
Centralia
Providence Regional Cancer System-Centralia
Status: Active
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org
Edmonds
Swedish Cancer Institute-Edmonds
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Everett
Providence Regional Cancer Partnership
Status: Active
Contact: Site Public Contact
Phone: 425-261-3529
Email: marilyn.birchman@providence.org
Issaquah
Swedish Cancer Institute-Issaquah
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Kennewick
Kadlec Clinic Hematology and Oncology
Status: Active
Contact: Site Public Contact
Phone: 509-783-4637
Email: research@kadlecmed.org
Lacey
Providence Regional Cancer System-Lacey
Status: Active
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org
Longview
PeaceHealth Saint John Medical Center
Status: Active
Contact: Site Public Contact
Phone: 360-514-2016
Email: kmakin-bond@peacehealth.org
Renton
Valley Medical Center
Status: Active
Contact: Site Public Contact
Phone: 425-228-3440
Email: research@valleymed.org
Seattle
Kaiser Permanente Washington
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Pacific Gynecology Specialists
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-Ballard Campus
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-Cherry Hill
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-First Hill
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Sedro-Woolley
PeaceHealth United General Medical Center
Status: Active
Contact: Site Public Contact
Phone: 360-788-8240
Shelton
Providence Regional Cancer System-Shelton
Status: Active
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org
Vancouver
PeaceHealth Southwest Medical Center
Status: Active
Contact: Site Public Contact
Phone: 360-514-3940
Email: kmakin-bond@peacehealth.org
Walla Walla
Providence Saint Mary Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 509-897-5993
Email: Cheryl.Dodd@providence.org
Yelm
Providence Regional Cancer System-Yelm
Status: Active
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org

Wisconsin

Ashland
Duluth Clinic Ashland
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org
Northwest Wisconsin Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org
Chippewa Falls
Marshfield Clinic-Chippewa Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Eau Claire
Marshfield Medical Center-EC Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
La Crosse
Gundersen Lutheran Medical Center
Status: Active
Contact: Site Public Contact
Phone: 608-775-2385
Email: cancerctr@gundersenhealth.org
Ladysmith
Marshfield Clinic - Ladysmith Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Marshfield
Marshfield Medical Center-Marshfield
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Minocqua
Marshfield Clinic-Minocqua Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
New Richmond
Cancer Center of Western Wisconsin
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Rice Lake
Marshfield Medical Center-Rice Lake
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Stevens Point
Marshfield Clinic Stevens Point Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Wausau
Marshfield Clinic-Wausau Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Weston
Marshfield Clinic - Weston Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Wisconsin Rapids
Marshfield Clinic - Wisconsin Rapids Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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

II. To describe rates of dose reductions, dose holds, and hospitalizations.

III. To estimate median time to treatment failure, including progression free survival and overall survival.

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

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

VI. To describe the results of the 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 for up to 5 years.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Alliance for Clinical Trials in Oncology

Principal Investigator
Mina S. Sedrak

Trial IDs

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