Taxane and Taxane-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer
NCT ID: NCT04001829
Last Updated: 2025-11-12
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
249 participants
INTERVENTIONAL
2019-08-09
2027-03-31
Brief Summary
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Detailed Description
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I. Prospectively validate a prior germline predictor of 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.
EXPLORATORY OBJECTIVES:
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) subscale, 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 the impact on financial toxicity (Comprehensive Score for Financial Toxicity \[COST\] scores) for every three-week docetaxel compared with weekly paclitaxel.
IV. 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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm A (paclitaxel)
Patients receive paclitaxel 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.
Paclitaxel
Given IV
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm B (docetaxel)
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.
Docetaxel
Given IV
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Docetaxel
Given IV
Paclitaxel
Given IV
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 must self-identify their race as black, African American, or of African descent; patients may be of any ethnicity
* Patients with a history of other cancers are eligible if they have not received prior taxane or platinum or vinca alkaloid therapy
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patients must not be pregnant or lactating
* All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
* A female 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)
* Women 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
Exclusion Criteria
* Patients have pre-existing peripheral neuropathy
* Patients have a total bilirubin \> upper limit of normal (ULN)
* Patients 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
ECOG-ACRIN Cancer Research Group
NETWORK
Responsible Party
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Principal Investigators
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Bryan P Schneider
Role: PRINCIPAL_INVESTIGATOR
ECOG-ACRIN Cancer Research Group
Locations
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States
Alaska Women's Cancer Care
Anchorage, Alaska, United States
Anchorage Oncology Centre
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
Kingman Regional Medical Center
Kingman, Arizona, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States
PCR Oncology
Arroyo Grande, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
Epic Care-Dublin
Dublin, California, United States
Bay Area Breast Surgeons Inc
Emeryville, California, United States
Epic Care Partners in Cancer Care
Emeryville, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
Bay Area Tumor Institute
Oakland, California, United States
Epic Care Cyberknife Center
Walnut Creek, California, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Boulder Community Hospital
Boulder, Colorado, United States
Boulder Community Foothills Hospital
Boulder, Colorado, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, United States
Cancer Center of Colorado at Sloan's Lake
Denver, Colorado, United States
National Jewish Health-Main Campus
Denver, Colorado, United States
The Women's Imaging Center
Denver, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, United States
SCL Health Saint Joseph Hospital
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Western Surgical Care
Denver, Colorado, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, United States
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
The Melanoma and Skin Cancer Institute
Englewood, Colorado, United States
National Jewish Health-Western Hematology Oncology
Golden, Colorado, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States
North Colorado Medical Center
Greeley, Colorado, United States
Good Samaritan Medical Center
Lafayette, Colorado, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
McKee Medical Center
Loveland, Colorado, United States
National Jewish Health-Northern Hematology Oncology
Thornton, Colorado, United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, United States
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, United States
Beebe South Coastal Health Campus
Frankford, Delaware, United States
Beebe Medical Center
Lewes, Delaware, United States
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
TidalHealth Nanticoke / Allen Cancer Center
Seaford, Delaware, United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, United States
Grady Health System
Atlanta, Georgia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
John B Amos Cancer Center
Columbus, Georgia, United States
Northside Hospital - Duluth
Duluth, Georgia, United States
Northside Hospital - Gwinnett
Lawrenceville, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States
Suburban Hematology Oncology Associates - Snellville
Snellville, Georgia, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, United States
Saint Anthony's Health
Alton, Illinois, United States
Rush - Copley Medical Center
Aurora, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, United States
SIH Cancer Institute
Carterville, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Centralia Oncology Clinic
Centralia, Illinois, United States
Northwestern University
Chicago, Illinois, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
Carle on Vermilion
Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Illinois CancerCare-Dixon
Dixon, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Valley Radiation Oncology
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Southwest Illinois Health Services LLP
Swansea, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
The Carle Foundation Hospital
Urbana, Illinois, United States
Illinois CancerCare - Washington
Washington, Illinois, United States
Rush-Copley Healthcare Center
Yorkville, Illinois, United States
IU Health West Hospital
Avon, Indiana, United States
IU Health North Hospital
Carmel, Indiana, United States
Northwest Cancer Center - Main Campus
Crown Point, Indiana, United States
Northwest Oncology LLC
Dyer, Indiana, United States
Northwest Cancer Center - Hobart
Hobart, Indiana, United States
Saint Mary Medical Center
Hobart, Indiana, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
IU Health Methodist Hospital
Indianapolis, Indiana, United States
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, United States
Springmill Medical Center
Indianapolis, Indiana, United States
Saint Catherine Hospital
Indianapolis, Indiana, United States
The Community Hospital
Munster, Indiana, United States
Women's Diagnostic Center - Munster
Munster, Indiana, United States
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana, United States
Central Care Cancer Center - Garden City
Garden City, Kansas, United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas, United States
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, United States
Our Lady of The Lake
Baton Rouge, Louisiana, United States
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Our Lady of the Lake Physicians Group - Medical Oncology
Baton Rouge, Louisiana, United States
Louisiana Hematology Oncology Associates
Baton Rouge, Louisiana, United States
Our Lady of the Lake Medical Oncology
Baton Rouge, Louisiana, United States
Woman's Hospital
Baton Rouge, Louisiana, United States
Northshore Oncology Associates-Covington
Covington, Louisiana, United States
Terrebonne General Medical Center
Houma, Louisiana, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Saint Agnes Hospital
Baltimore, Maryland, United States
MedStar Good Samaritan Hospital
Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
University of Maryland Shore Medical Center at Easton
Easton, Maryland, United States
Northwest Hospital Center
Randallstown, Maryland, United States
William E Kahlert Regional Cancer Center/Sinai Hospital
Westminster, Maryland, United States
Mercy Medical Center
Springfield, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Bronson Battle Creek
Battle Creek, Michigan, United States
IHA Hematology Oncology Consultants-Brighton
Brighton, Michigan, United States
Saint Joseph Mercy Brighton
Brighton, Michigan, United States
IHA Hematology Oncology Consultants-Canton
Canton, Michigan, United States
Saint Joseph Mercy Canton
Canton, Michigan, United States
Caro Cancer Center
Caro, Michigan, United States
IHA Hematology Oncology Consultants-Chelsea
Chelsea, Michigan, United States
Saint Joseph Mercy Chelsea
Chelsea, Michigan, United States
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, United States
Newland Medical Associates-Clarkston
Clarkston, Michigan, United States
Ascension Saint John Hospital
Detroit, Michigan, United States
Great Lakes Cancer Management Specialists-Doctors Park
East China, Michigan, United States
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, United States
Genesee Hematology Oncology PC
Flint, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
Academic Hematology Oncology Specialists
Grosse Pointe Woods, Michigan, United States
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, United States
Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Ascension Borgess Cancer Center
Kalamazoo, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
Hope Cancer Clinic
Livonia, Michigan, United States
Saint Mary Mercy Hospital
Livonia, Michigan, United States
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan, United States
Michigan Breast Specialists-Macomb Township
Macomb, Michigan, United States
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan, United States
Mercy Health Mercy Campus
Muskegon, Michigan, United States
Lakeland Hospital Niles
Niles, Michigan, United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, United States
21st Century Oncology-Pontiac
Pontiac, Michigan, United States
Hope Cancer Center
Pontiac, Michigan, United States
Newland Medical Associates-Pontiac
Pontiac, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Spectrum Health Reed City Hospital
Reed City, Michigan, United States
Great Lakes Cancer Management Specialists-Rochester Hills
Rochester Hills, Michigan, United States
Ascension Saint Mary's Hospital
Saginaw, Michigan, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan, United States
Ascension Saint Joseph Hospital
Tawas City, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Advanced Breast Care Center PLLC
Warren, Michigan, United States
Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, Michigan, United States
Macomb Hematology Oncology PC
Warren, Michigan, United States
Michigan Breast Specialists-Warren
Warren, Michigan, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States
Huron Gastroenterology PC
Ypsilanti, Michigan, United States
IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti, Michigan, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, United States
Cambridge Medical Center
Cambridge, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Health Partners Inc
Minneapolis, Minnesota, United States
Monticello Cancer Center
Monticello, Minnesota, United States
New Ulm Medical Center
New Ulm, Minnesota, United States
Fairview Northland Medical Center
Princeton, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States
Fairview Lakes Medical Center
Wyoming, Minnesota, United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, United States
Baptist Cancer Center-Grenada
Grenada, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, United States
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, United States
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, United States
Cox Cancer Center Branson
Branson, Missouri, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Southeast Cancer Center
Cape Girardeau, Missouri, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States
Parkland Health Center - Farmington
Farmington, Missouri, United States
Capital Region Southwest Campus
Jefferson City, Missouri, United States
Freeman Health System
Joplin, Missouri, United States
Mercy Hospital Joplin
Joplin, Missouri, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mercy Hospital South
St Louis, Missouri, United States
Siteman Cancer Center-South County
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, United States
Mercy Hospital Washington
Washington, Missouri, United States
Saint Vincent Healthcare
Billings, Montana, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
Nebraska Medicine-Bellevue
Bellevue, Nebraska, United States
Nebraska Medicine-Village Pointe
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Carson Tahoe Regional Medical Center
Carson City, Nevada, United States
Cancer and Blood Specialists-Henderson
Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, United States
Las Vegas Cancer Center-Henderson
Henderson, Nevada, United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, United States
21st Century Oncology-Henderson
Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, United States
Las Vegas Urology - Green Valley
Henderson, Nevada, United States
Las Vegas Urology - Pebble
Henderson, Nevada, United States
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, United States
Las Vegas Urology - Pecos
Las Vegas, Nevada, United States
Desert West Surgery
Las Vegas, Nevada, United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Hope Cancer Care of Nevada
Las Vegas, Nevada, United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, United States
Urology Specialists of Nevada - Central
Las Vegas, Nevada, United States
21st Century Oncology
Las Vegas, Nevada, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States
Las Vegas Prostate Cancer Center
Las Vegas, Nevada, United States
Las Vegas Urology - Sunset
Las Vegas, Nevada, United States
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, United States
21st Century Oncology-Vegas Tenaya
Las Vegas, Nevada, United States
Ann M Wierman MD LTD
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, United States
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada, United States
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada, United States
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, United States
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, United States
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, United States
21st Century Oncology-Fort Apache
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, United States
University Cancer Center
Las Vegas, Nevada, United States
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada, United States
Renown Regional Medical Center
Reno, Nevada, United States
Saint Mary's Regional Medical Center
Reno, Nevada, United States
Radiation Oncology Associates
Reno, Nevada, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
The Cancer Institute of New Jersey Hamilton
Hamilton, New Jersey, United States
Morristown Medical Center
Morristown, New Jersey, United States
Inspira Medical Center Mullica Hill
Mullica Hill, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States
Overlook Hospital
Summit, New Jersey, United States
Holy Name Hospital
Teaneck, New Jersey, United States
Inspira Medical Center Vineland
Vineland, New Jersey, United States
University of Rochester
Rochester, New York, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Cleveland Clinic Akron General
Akron, Ohio, United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, United States
Strecker Cancer Center-Belpre
Belpre, Ohio, United States
Geauga Hospital
Chardon, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Mount Carmel East Hospital
Columbus, Ohio, United States
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Grant Medical Center
Columbus, Ohio, United States
The Mark H Zangmeister Center
Columbus, Ohio, United States
Mount Carmel Health Center West
Columbus, Ohio, United States
Doctors Hospital
Columbus, Ohio, United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Dublin Methodist Hospital
Dublin, Ohio, United States
Central Ohio Breast and Endocrine Surgery
Gahanna, Ohio, United States
Mount Carmel Grove City Hospital
Grove City, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Saint Rita's Medical Center
Lima, Ohio, United States
OhioHealth Mansfield Hospital
Mansfield, Ohio, United States
Marietta Memorial Hospital
Marietta, Ohio, United States
OhioHealth Marion General Hospital
Marion, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, United States
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio, United States
Knox Community Hospital
Mount Vernon, Ohio, United States
Licking Memorial Hospital
Newark, Ohio, United States
Newark Radiation Oncology
Newark, Ohio, United States
University Hospitals Parma Medical Center
Parma, Ohio, United States
Mercy Health Perrysburg Cancer Center
Perrysburg, Ohio, United States
Southern Ohio Medical Center
Portsmouth, Ohio, United States
University Hospitals Portage Medical Center
Ravenna, Ohio, United States
UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, United States
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States
Mercy Health - Saint Anne Hospital
Toledo, Ohio, United States
University Hospitals Sharon Health Center
Wadsworth, Ohio, United States
Saint Ann's Hospital
Westerville, Ohio, United States
UH Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States
Saint Charles Health System
Bend, Oregon, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, United States
Bay Area Hospital
Coos Bay, Oregon, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Saint Charles Health System-Redmond
Redmond, Oregon, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, United States
Main Line Health Center-Collegeville
Collegeville, Pennsylvania, United States
Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
East Norriton, Pennsylvania, United States
Pocono Medical Center
East Stroudsburg, Pennsylvania, United States
Main Line Health Center-Exton
Exton, Pennsylvania, United States
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, United States
Riddle Memorial Hospital
Media, Pennsylvania, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Tidelands Georgetown Memorial Hospital
Georgetown, South Carolina, United States
Self Regional Healthcare
Greenwood, South Carolina, United States
South Carolina Cancer Specialists PC
Hilton Head Island, South Carolina, United States
Lexington Medical Center
West Columbia, South Carolina, United States
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, United States
Baptist Memorial Hospital for Women
Memphis, Tennessee, United States
Baptist Hospitals of Southeast Texas Cancer Center
Beaumont, Texas, United States
Baptist Regional Cancer Network-Cancer Center of Southeast Texas
Port Arthur, Texas, United States
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, United States
Sandra L Maxwell Cancer Center
Cedar City, Utah, United States
Logan Regional Hospital
Logan, Utah, United States
Intermountain Medical Center
Murray, Utah, United States
McKay-Dee Hospital Center
Ogden, Utah, United States
Utah Valley Regional Medical Center
Provo, Utah, United States
Riverton Hospital
Riverton, Utah, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Dixie Medical Center Regional Cancer Center
St. George, Utah, United States
Augusta Health Center for Cancer and Blood Disorders
Fishersville, Virginia, United States
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, United States
Bon Secours Westchester Emergency Center
Midlothian, Virginia, United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, United States
Bon Secours DePaul Medical Center
Norfolk, Virginia, United States
Bon Secours Maryview Medical Center
Portsmouth, Virginia, United States
Bon Secours Saint Mary's Hospital
Richmond, Virginia, United States
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, United States
Bon Secours Health Center at Harbour View
Suffolk, Virginia, United States
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, United States
MultiCare Auburn Medical Center
Auburn, Washington, United States
Overlake Medical Center
Bellevue, Washington, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
MultiCare Gig Harbor Medical Park
Gig Harbor, Washington, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Providence Regional Cancer System-Lacey
Lacey, Washington, United States
PeaceHealth Saint John Medical Center
Longview, Washington, United States
Jefferson Healthcare
Port Townsend, Washington, United States
MultiCare Good Samaritan Hospital
Puyallup, Washington, United States
Valley Medical Center
Renton, Washington, United States
Pacific Gynecology Specialists
Seattle, Washington, United States
Swedish Medical Center-Ballard Campus
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
Swedish Medical Center-Cherry Hill
Seattle, Washington, United States
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, United States
Providence Regional Cancer System-Shelton
Shelton, Washington, United States
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Spokane, Washington, United States
MultiCare Deaconess Cancer and Blood Specialty Center - North
Spokane, Washington, United States
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
Spokane Valley, Washington, United States
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States
Providence Regional Cancer System-Yelm
Yelm, Washington, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, United States
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, United States
Aurora Health Center-Fond du Lac
Fond du Lac, Wisconsin, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States
Aurora Medical Center in Summit
Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, United States
Countries
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References
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Schneider BP, Zhao F, Ballinger TJ, Garcia SF, Shen F, Virani S, Cella D, Bales C, Jiang G, Hayes L, Miller N, Srinivasiah J, Stringer-Reasor EM, Chitalia A, Davis AA, Makower DF, Incorvati J, Simon MA, Mitchell EP, DeMichele A, Miller KD, Sparano JA, Wagner LI, Wolff AC. ECOG-ACRIN EAZ171: Prospective Validation Trial of Germline Predictors of Taxane-Induced Peripheral Neuropathy in Black Women With Early-Stage Breast Cancer. J Clin Oncol. 2024 Aug 20;42(24):2899-2907. doi: 10.1200/JCO.24.00526. Epub 2024 Jun 3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2019-00266
Identifier Type: REGISTRY
Identifier Source: secondary_id
EAZ171
Identifier Type: OTHER
Identifier Source: secondary_id
ECOG-ACRIN-EAZ171
Identifier Type: OTHER
Identifier Source: secondary_id
EAZ171
Identifier Type: OTHER
Identifier Source: secondary_id
EAZ171
Identifier Type: -
Identifier Source: org_study_id