Breast Cancer
EAZ171
Docetaxel or Paclitaxel in Reducing Chemotherapy-Induced Peripheral Neuropathy in African American Patients with Stage I-III Breast Cancer
STATUS: Closed to Accrual
This phase II trial studies how well docetaxel or paclitaxel work in reducing chemotherapy-induced peripheral neuropathy in African American patients with stages I-III breast cancer. Drugs used in chemotherapy, such as docetaxel and paclitaxel, 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 whether giving docetaxel or paclitaxel may work better than other methods in reducing chemotherapy-induced peripheral neuropathy in patients with breast cancer.
- Patients must be women with a known stage I-III invasive breast cancer diagnosis
- Patients must be capable and willing to provide informed consent
- Patients must have plans to receive either neoadjuvant or adjuvant: * Every 3-week docetaxel x 4-6 cycles OR * Weekly paclitaxel x 4 cycles * NOTE: Recommended therapies for various therapy regimens are outlined based on estrogen receptor (ER)/progesterone receptor (PR)/HER2 and nodal status. Where there are options, the treating physician will choose a regimen best fitted for that patient. If the physician does not feel any of the regimens are the best fit for the patient, the patient should not be enrolled. Physicians will also document why a regimen was felt to be inappropriate when an option. Patients who have already started the anthracycline portion of their therapy are eligible assuming they have not yet begun the taxane portion and assuming they will be receiving one of the regimens deemed appropriate for her disease setting
- Patients must self-identify their race as black, African American, or of African descent; patients may be of any ethnicity
- Patients must not have received prior taxane or prior/concurrent platinum therapy
- Patients must not have received neoadjuvant anti-HER2 therapy
- Patients with a history of other cancers are eligible if they have not received prior taxane or platinum or vinca alkaloid therapy
- Patients must not have pre-existing peripheral neuropathy
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Patients must not have a total bilirubin > upper limit of normal (ULN) (must be obtained within 3 weeks prior to registration)
- Patients must not have aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 1.5 times the ULN concomitant with alkaline phosphatase above 2.5 times the ULN (must be obtained within 3 weeks prior to registration)
- Patients must not be pregnant or lactating * All patients of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy * A patient of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Patients of childbearing potential must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
United States
AK
Anchorage
Alaska Breast Care and Surgery LLC
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Alaska Oncology and Hematology LLC
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Alaska Women's Cancer Care
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Anchorage Associates in Radiation Medicine
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Anchorage Oncology Centre
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Anchorage Radiation Therapy Center
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Katmai Oncology Group
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Providence Alaska Medical Center
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AL
Birmingham
University of Alabama at Birmingham Cancer Center
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AR
Ft. Smith
Mercy Hospital Fort Smith
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Jonesboro
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
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AZ
CA
Burbank
Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Dublin
Epic Care-Dublin
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Emeryville
Bay Area Breast Surgeons Inc
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Epic Care Partners in Cancer Care
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Martinez
Contra Costa Regional Medical Center
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Oakland
Alta Bates Summit Medical Center - Summit Campus
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Bay Area Tumor Institute
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CO
Aurora
Rocky Mountain Cancer Centers-Aurora
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The Medical Center of Aurora
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Boulder
Boulder Community Foothills Hospital
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Rocky Mountain Cancer Centers-Boulder
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Centennial
Rocky Mountain Cancer Centers - Centennial
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Denver
Cancer Center of Colorado at Sloan's Lake
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Colorado Blood Cancer Institute
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National Jewish Health-Main Campus
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Presbyterian - Saint Lukes Medical Center - Health One
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Rose Medical Center
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Saint Joseph Hospital - Cancer Centers of Colorado
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The Women's Imaging Center
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Western Surgical Care
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Mountain Blue Cancer Care Center - Swedish
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Rocky Mountain Cancer Centers - Swedish
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Swedish Medical Center
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The Melanoma and Skin Cancer Institute
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Golden
National Jewish Health-Western Hematology Oncology
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Grand Junction
Saint Mary's Hospital and Regional Medical Center
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Lafayette
Good Samaritan Hospital - Cancer Centers of Colorado
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Littleton
Rocky Mountain Cancer Centers-Littleton
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Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
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Sky Ridge Medical Center
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Loveland
Banner North Colorado Medical Center - Loveland Campus
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Thornton
National Jewish Health-Northern Hematology Oncology
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Rocky Mountain Cancer Centers-Thornton
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Wheat Ridge
Intermountain Health Lutheran Hospital
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Washington
MedStar Washington Hospital Center
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DE
Newark
Christiana Care Health System-Christiana Hospital
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Delaware Clinical and Laboratory Physicians PA
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Helen F Graham Cancer Center
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Medical Oncology Hematology Consultants PA
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Seaford
TidalHealth Nanticoke / Allen Cancer Center
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Wilmington
Christiana Care Health System-Wilmington Hospital
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FL
Fort Lauderdale
Holy Cross Hospital
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Gainesville
UF Health Cancer Institute - Gainesville
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Atlanta
Emory Saint Joseph's Hospital
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Grady Health System
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Northside Hospital
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Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Snellville
Suburban Hematology Oncology Associates - Snellville
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ID
Fruitland
Saint Luke's Cancer Institute - Fruitland
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Meridian
Saint Luke's Cancer Institute - Meridian
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Twin Falls
Saint Luke's Cancer Institute - Twin Falls
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IL
Alton
OSF Saint Anthony's Health Center
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Chicago
John H Stroger Jr Hospital of Cook County
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Northwestern University
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Decatur
Cancer Care Specialists of Illinois - Decatur
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Decatur Memorial Hospital
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Dixon
Illinois CancerCare-Dixon
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Effingham
Carle Physician Group-Effingham
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Crossroads Cancer Center
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Galesburg
Illinois CancerCare-Galesburg
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Western Illinois Cancer Treatment Center
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Mount Vernon
SSM Health Good Samaritan
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Peoria
Illinois CancerCare-Peoria
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Methodist Medical Center of Illinois
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Peru
Illinois CancerCare-Peru
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Valley Radiation Oncology
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Springfield
Southern Illinois University School of Medicine
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Springfield Clinic
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Springfield Memorial Hospital
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Urbana
Carle Cancer Center
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The Carle Foundation Hospital
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IN
Crown Point
Northwest Cancer Center - Crown Point
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Dyer
Northwest Oncology LLC
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Hobart
Northwest Cancer Center - Hobart
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Saint Mary Medical Center
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Indianapolis
IU Health Methodist Hospital
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Indiana University/Melvin and Bren Simon Cancer Center
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Saint Catherine Hospital
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Sidney and Lois Eskenazi Hospital
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Springmill Medical Center
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Munster
The Community Hospital
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Women's Diagnostic Center - Munster
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KS
Garden City
Central Care Cancer Center - Garden City
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Great Bend
Central Care Cancer Center - Great Bend
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LA
Baton Rouge
LSU Health Baton Rouge-North Clinic
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Louisiana Hematology Oncology Associates
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Louisiana Hematology Oncology Associates LLC
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Mary Bird Perkins Cancer Center
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Our Lady of The Lake
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Our Lady of the Lake Medical Oncology
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Our Lady of the Lake Physician Group
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Woman's Hospital
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Covington
Northshore Oncology Associates-Covington
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New Orleans
Louisiana State University Health Science Center
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University Medical Center New Orleans
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MA
Springfield
Baystate Medical Center
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Mercy Medical Center
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MD
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
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MedStar Good Samaritan Hospital
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Saint Agnes Hospital
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Sinai Hospital of Baltimore
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Easton
University of Maryland Shore Medical Center at Easton
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Westminster
William E Kahlert Regional Cancer Center/Sinai Hospital
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MI
Ann Arbor
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Brighton
Trinity Health IHA Medical Group Hematology Oncology - Brighton
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Trinity Health Medical Center - Brighton
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Canton
Trinity Health IHA Medical Group Hematology Oncology - Canton
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Trinity Health Medical Center - Canton
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Chelsea
Chelsea Hospital
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Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Clarkston
Hematology Oncology Consultants-Clarkston
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Newland Medical Associates-Clarkston
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Flint
Cancer Hematology Centers - Flint
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Genesee Hematology Oncology PC
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Genesys Hurley Cancer Institute
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Hurley Medical Center
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Grand Rapids
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Trinity Health Grand Rapids Hospital
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Grosse Pointe Woods
Henry Ford Saint John Hospital - Academic
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Henry Ford Saint John Hospital - Breast
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Henry Ford Saint John Hospital - Van Elslander
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Kalamazoo
Beacon Kalamazoo
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Beacon Kalamazoo Cancer Center
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Bronson Methodist Hospital
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West Michigan Cancer Center
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Lansing
University of Michigan Health - Sparrow Lansing
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Livonia
Hope Cancer Clinic
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Trinity Health Saint Mary Mercy Livonia Hospital
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Macomb Township
Henry Ford Saint John Hospital - Macomb Medical
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Henry Ford Warren Hospital - Breast Macomb
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Marlette
Saint Mary's Oncology/Hematology Associates of Marlette
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Niles
Corewell Health Lakeland Hospitals - Niles Hospital
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Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
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Pontiac
Hope Cancer Center
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Michigan Healthcare Professionals Pontiac
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Newland Medical Associates-Pontiac
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Trinity Health Saint Joseph Mercy Oakland Hospital
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Saginaw
MyMichigan Medical Center Saginaw
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Oncology Hematology Associates of Saginaw Valley PC
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Saint Joseph
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Corewell Health Lakeland Hospitals - Saint Joseph Hospital
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Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
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Warren
Advanced Breast Care Center PLLC
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Henry Ford Health Warren Hospital
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Henry Ford Madison Heights Hospital - Breast
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Henry Ford Warren Hospital - GLCMS
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Macomb Hematology Oncology PC
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West Branch
Saint Mary's Oncology/Hematology Associates of West Branch
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Ypsilanti
Huron Gastroenterology PC
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Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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MN
Burnsville
Fairview Ridges Hospital
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Minnesota Oncology - Burnsville
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Maple Grove
Fairview Clinics and Surgery Center Maple Grove
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Maplewood
Minnesota Oncology Hematology PA-Maplewood
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Saint John's Hospital - Healtheast
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Minneapolis
Abbott-Northwestern Hospital
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Health Partners Inc
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Hennepin County Medical Center
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Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
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Saint Paul
Regions Hospital
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United Hospital
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Woodbury
Minnesota Oncology Hematology PA-Woodbury
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MO
Ballwin
Mercy Oncology and Hematology - Clayton-Clarkson
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Bonne Terre
Parkland Health Center-Bonne Terre
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Branson
Cox Cancer Center Branson
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Cape Girardeau
Mercy Cancer Center - Cape Girardeau
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Saint Francis Medical Center
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Creve Coeur
Siteman Cancer Center at West County Hospital
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Farmington
Parkland Health Center - Farmington
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Jefferson City
MU Health Care Goldschmidt Cancer Center
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Joplin
Freeman Health System
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Mercy Hospital Joplin
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Rolla
Mercy Clinic-Rolla-Cancer and Hematology
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Phelps Health Delbert Day Cancer Institute
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Saint Louis
Mercy Hospital Saint Louis
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Mercy Hospital South
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Mercy Infusion Center - Chippewa
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Missouri Baptist Medical Center
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Siteman Cancer Center at Christian Hospital
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Siteman Cancer Center-South County
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Washington University School of Medicine
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Saint Peters
Siteman Cancer Center at Saint Peters Hospital
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Sainte Genevieve
Sainte Genevieve County Memorial Hospital
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Springfield
CoxHealth South Hospital
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Mercy Hospital Springfield
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Sullivan
Missouri Baptist Sullivan Hospital
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Washington
Mercy Hospital Washington
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MS
Columbus
Baptist Memorial Hospital and Cancer Center-Golden Triangle
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New Albany
Baptist Memorial Hospital and Cancer Center-Union County
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Oxford
Baptist Memorial Hospital and Cancer Center-Oxford
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Southhaven
Baptist Memorial Hospital and Cancer Center-Desoto
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MT
Billings
Saint Vincent Frontier Cancer Center
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Saint Vincent Healthcare
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Butte
Saint James Community Hospital and Cancer Treatment Center
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Missoula
Saint Patrick Hospital - Community Hospital
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NE
Omaha
Nebraska Medicine-Village Pointe
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University of Nebraska Medical Center
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NJ
Englewood
Englewood Hospital and Medical Center
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Hamilton
The Cancer Institute of New Jersey Hamilton
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Morristown
Morristown Medical Center
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New Brunswick
Rutgers Cancer Institute of New Jersey
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Sewell
Sidney Kimmel Cancer Center Washington Township
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Somerville
Robert Wood Johnson University Hospital Somerset
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Summit
Overlook Hospital
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Teaneck
Holy Name Hospital
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Vineland
Inspira Medical Center Vineland
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NV
Henderson
Cancer and Blood Specialists-Henderson
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Comprehensive Cancer Centers of Nevada - Henderson
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Comprehensive Cancer Centers of Nevada-Horizon Ridge
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Comprehensive Cancer Centers of Nevada-Southeast Henderson
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Las Vegas Cancer Center-Henderson
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Las Vegas Urology - Green Valley
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Las Vegas Urology - Pebble
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Oncology Las Vegas - Henderson
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Urology Specialists of Nevada - Green Valley
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Las Vegas
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Ann M Wierman MD LTD
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Comprehensive Cancer Centers of Nevada
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Comprehensive Cancer Centers of Nevada - Central Valley
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Comprehensive Cancer Centers of Nevada - Northwest
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Comprehensive Cancer Centers of Nevada - Town Center
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Comprehensive Cancer Centers of Nevada-Summerlin
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Desert West Surgery
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Hope Cancer Care of Nevada
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Las Vegas Cancer Center-Medical Center
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Las Vegas Prostate Cancer Center
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Las Vegas Urology - Cathedral Rock
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Las Vegas Urology - Pecos
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Las Vegas Urology - Smoke Ranch
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Las Vegas Urology - Sunset
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Oncology Las Vegas - Tenaya
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OptumCare Cancer Care at Charleston
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OptumCare Cancer Care at Fort Apache
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OptumCare Cancer Care at MountainView
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Radiation Oncology Centers of Nevada Central
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Radiation Oncology Centers of Nevada Southeast
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Summerlin Hospital Medical Center
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Sunrise Hospital and Medical Center
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University Cancer Center
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University Medical Center of Southern Nevada
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Urology Specialists of Nevada - Central
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Urology Specialists of Nevada - Northwest
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Urology Specialists of Nevada - Southwest
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Reno
Radiation Oncology Associates
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Renown Regional Medical Center
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Saint Mary's Regional Medical Center
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NY
Bronx
Montefiore Medical Center - Moses Campus
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Montefiore Medical Center-Einstein Campus
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Montefiore Medical Center-Weiler Hospital
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Rochester
University of Rochester
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OH
Cleveland
Case Western Reserve University
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MetroHealth Medical Center
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Columbus
Columbus Oncology and Hematology Associates Inc
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Doctors Hospital
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Grant Medical Center
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Mount Carmel East Hospital
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Mount Carmel Health Center West
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Riverside Methodist Hospital
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The Mark H Zangmeister Center
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Delaware
Delaware Health Center-Grady Cancer Center
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Grady Memorial Hospital
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Dublin
Columbus Oncology and Hematology Associates
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Dublin Methodist Hospital
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Gahanna
Central Ohio Breast and Endocrine Surgery
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Lima
Saint Rita's Medical Center
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Mentor
UH Seidman Cancer Center at Lake Health Mentor Campus
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Middleburg Heights
UH Seidman Cancer Center at Southwest General Hospital
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Newark
Licking Memorial Hospital
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Newark Radiation Oncology
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Ravenna
University Hospitals Portage Medical Center
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Sandusky
UH Seidman Cancer Center at Firelands Regional Medical Center
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Toledo
Mercy Health Sylvania Radiation Oncology Center
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Mercy Health - Saint Anne Hospital
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Mercy Health - Saint Vincent Hospital
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Wadsworth
University Hospitals Sharon Health Center
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Westlake
UH Seidman Cancer Center at Saint John Medical Center
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Zanesville
Genesis Healthcare System Cancer Care Center
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OK
Oklahoma City
Mercy Hospital Oklahoma City
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OR
Clackamas
Clackamas Radiation Oncology Center
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Email: [email protected]
Providence Cancer Institute Clackamas Clinic
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Portland
Providence Portland Medical Center
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Providence Saint Vincent Medical Center
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Redmond
Saint Charles Health System-Redmond
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PA
Chadds Ford
Christiana Care Health System-Concord Health Center
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Collegeville
Main Line Health Center-Collegeville
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East Norriton
Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
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Philadelphia
Fox Chase Cancer Center
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Jefferson Torresdale Hospital
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Email: [email protected]
Temple University Hospital
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Thomas Jefferson University Hospital
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SC
Bluffton
Saint Joseph's/Candler - Bluffton Campus
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Email: [email protected]
Georgetown
Tidelands Georgetown Memorial Hospital
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Hilton Head Island
South Carolina Cancer Specialists PC
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TN
Collierville
Baptist Memorial Hospital and Cancer Center-Collierville
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Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
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Baptist Memorial Hospital for Women
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TX
Beaumont
Baptist Hospitals of Southeast Texas Cancer Center
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Port Arthur
Baptist Regional Cancer Network-Cancer Center of Southeast Texas
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UT
American Fork
American Fork Hospital / Huntsman Intermountain Cancer Center
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Saint George
Saint George Regional Medical Center
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Salt Lake City
LDS Hospital
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Utah Cancer Specialists-Salt Lake City
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VA
Fishersville
Augusta Health Center for Cancer and Blood Disorders
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Mechanicsville
Bon Secours Memorial Regional Medical Center
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Midlothian
Bon Secours Saint Francis Medical Center
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Bon Secours Westchester Emergency Center
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Richmond
Bon Secours Cancer Institute at Reynolds Crossing
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Bon Secours Saint Mary's Hospital
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Suffolk
Bon Secours Health Center at Harbour View
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WA
Aberdeen
Providence Regional Cancer System-Aberdeen
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Bellingham
PeaceHealth Saint Joseph Medical Center
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Centralia
Providence Regional Cancer System-Centralia
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Port Townsend
Jefferson Healthcare
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Seattle
Pacific Gynecology Specialists
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Swedish Medical Center-Ballard Campus
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Swedish Medical Center-Cherry Hill
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Swedish Medical Center-First Hill
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Sedro-Woolley
PeaceHealth United General Medical Center
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Shelton
Providence Regional Cancer System-Shelton
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Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
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MultiCare Deaconess Cancer and Blood Specialty Center - North
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Spokane Valley
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
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Tacoma
Mary Bridge Children's Hospital and Health Center
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MultiCare Tacoma General Hospital
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Walla Walla
Providence Saint Mary Regional Cancer Center
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Yakima
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
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WI
Burlington
Aurora Cancer Care-Southern Lakes VLCC
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Germantown
Aurora Health Care Germantown Health Center
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Marinette
Aurora Bay Area Medical Group-Marinette
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Milwaukee
Aurora Cancer Care-Milwaukee
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Aurora Saint Luke's Medical Center
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Aurora Sinai Medical Center
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Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
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WY
PRIMARY OBJECTIVE: I. Prospectively validate a prior germline predictor of paclitaxel-induced peripheral neuropathy (TIPN) using the Common Terminology Criteria for Adverse Events (CTCAE). Specifically, this study will demonstrate that patients with a high-risk TIPN genotype have significantly more grade 2-4 TIPN than patients with a low risk genotype. SECONDARY OBJECTIVES: I. Validate a prior germline predictor of TIPN using the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) neurotoxicity subscale in Arm A. II. Compare grade 2-4 TIPN based on CTCAE between weekly paclitaxel (Arm A) versus (vs.) every three-week docetaxel (Arm B). III. Prospectively confirm dose reductions due to TIPN are lower for every three-week docetaxel compared with weekly paclitaxel in a prospective cohort of patients of African ancestry. IV. Prospectively confirm dose reductions due to any cause are lower for every three-week docetaxel compared with weekly paclitaxel in a prospective cohort of patients of African ancestry. V. Assess the ability of the high-risk genotype to predict TIPN risk for docetaxel. CORRELATIVE STUDY OBJECTIVES: I. Identify novel markers of TIPN and elucidate the mechanism. II. Whole genome sequencing of germline blood to evaluate for additional predictors of TIPN. III. Create induced pluripotent stem cell (iPSC) derived neurons from patient samples. IIIa. Evaluate whether clinical findings can be mimicked in vitro. IIIb. Evaluate gene expression (ribonucleic acid [RNA] sequencing [seq]) and the epigenome at baseline versus after exposure in those prone to TIPN versus those not. IV. Create a biorepository of patient derived samples for future translational research. PATIENT REPORTED OUTCOME OBJECTIVES: I. Compare grade 2-4 TIPN (moderate to life threatening) based on Patient Reported Outcomes (PRO)-CTCAE items between weekly paclitaxel (Arm A) vs. every three-week docetaxel (Arm B). II. Prospectively compare FACT/GOG-NTX Health-Related Quality of Life (HRQoL) scores (from the FACT-General [G] portion and Patient-Reported Outcomes Measurement Information System [PROMIS] Physical Function version [v.]2 Short Form [SF] 10a, scores between every three-week docetaxel and weekly paclitaxel and between high risk and low risk genotypes (Arm A) in a cohort of African ancestry. III. Compare Chemotherapy-Induced Peripheral Neuropathy (CIPN)-20 sensory neuropathy score between weekly paclitaxel (Arm A) vs. every three-week docetaxel (Arm B). IV. Compare the impact on financial toxicity (Comprehensive Score for Financial Toxicity [COST] scores) for every three-week docetaxel compared with weekly paclitaxel. V. Examine associations between social determinants of health (zip code, marital status, education, income & insurance status) and dose reductions and treatment discontinuation. OUTLINE: Patients are assigned to 1 of 2 arms. ARM A: Patients receive paclitaxel intravenously (IV) over 3 hours once weekly. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may also receive trastuzumab and/or pertuzumab per institution routine care per treating physician’s discretion. ARM B: Patients receive docetaxel IV over 1 hour once every 3 weeks. Treatment repeats every 21 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity. Patients may also receive cyclophosphamide, doxorubicin, trastuzumab, and/or pertuzumab per institution routine care per treating physician’s discretion. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.
The ECOG-ACRIN Cancer Research Group designed and conducted this trial with funding from the National Cancer Institute through its NCI Community Oncology Research Program (NCORP).

Breast cancer survivors and advocates from R.E.D Alliance and Pink 4 Ever, Inc. discuss their experiences.
Study Chair Bryan P. Schneider, MD of the Indiana University Melvin and Bren Simon Cancer Center discusses EAZ171

