AzTrials
AzTrials

Anatomic Stage I Breast Cancer AJCC v8Phase 2NCT04001829

Docetaxel or Paclitaxel in Reducing Chemotherapy-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer

A Phase 2 study testing Docetaxel, Paclitaxel and Quality-of-Life Assessment in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by ECOG-ACRIN Cancer Research Group at 482 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Docetaxel, Paclitaxel and Quality-of-Life Assessment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
249 participants
Where
482 sitesUnited States
Study dates
9 Aug 2019to 5 Apr 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • 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

Who cannot join

  • Patients must not have received prior taxane or prior/concurrent platinum therapy
  • Patients must not have received neoadjuvant anti-HER2 therapy
  • Patients must not have pre-existing peripheral neuropathy
  • 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)

Trial locations and contacts

482 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • OSF Saint Anthony's Health Center

    Alton, Illinois, 62002

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • PCR Oncology

    Arroyo Grande, California, 93420

  • Grady Health System

    Atlanta, Georgia, 30303

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • Northside Hospital

    Atlanta, Georgia, 30342

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

  • IU Health West Hospital

    Avon, Indiana, 46123

  • Mercy Oncology and Hematology - Clayton-Clarkson

    Ballwin, Missouri, 63011

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • MedStar Good Samaritan Hospital

    Baltimore, Maryland, 21239

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • LSU Health Baton Rouge-North Clinic

    Baton Rouge, Louisiana, 70805

  • Our Lady of the Lake Physician Group

    Baton Rouge, Louisiana, 70808

  • Our Lady of The Lake

    Baton Rouge, Louisiana, 70808

  • Louisiana Hematology Oncology Associates LLC

    Baton Rouge, Louisiana, 70809

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Louisiana Hematology Oncology Associates

    Baton Rouge, Louisiana, 70817

  • Our Lady of the Lake Medical Oncology

    Baton Rouge, Louisiana, 70817

  • Woman's Hospital

    Baton Rouge, Louisiana, 70817

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

  • Baptist Hospitals of Southeast Texas Cancer Center

    Beaumont, Texas, 77701

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

  • Overlake Medical Center

    Bellevue, Washington, 98004

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Joseph's/Candler - Bluffton Campus

    Bluffton, South Carolina, 29910

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

  • Boulder Community Foothills Hospital

    Boulder, Colorado, 80303

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

  • Mercy Cancer Center - Cape Girardeau

    Cape Girardeau, Missouri, 63703

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • IU Health North Hospital

    Carmel, Indiana, 46032

  • Caro Cancer Center

    Caro, Michigan, 48723

  • Carson Tahoe Regional Medical Center

    Carson City, Nevada, 89703

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Rocky Mountain Cancer Centers - Centennial

    Centennial, Colorado, 80112

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • Geauga Hospital

    Chardon, Ohio, 44024

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Chelsea Hospital

    Chelsea, Michigan, 48118

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wyoming, 82001

  • Northwestern University

    Chicago, Illinois, 60611

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Main Line Health Center-Collegeville

    Collegeville, Pennsylvania, 19426

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    Columbus, Mississippi, 39705

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Northshore Oncology Associates-Covington

    Covington, Louisiana, 70433

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • Northwest Cancer Center - Crown Point

    Crown Point, Indiana, 46307

  • Aurora Saint Luke's South Shore

    Cudahy, Wisconsin, 53110

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Cancer Center of Colorado at Sloan's Lake

    Denver, Colorado, 80204

  • National Jewish Health-Main Campus

    Denver, Colorado, 80206

  • The Women's Imaging Center

    Denver, Colorado, 80209

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • Saint Joseph Hospital - Cancer Centers of Colorado

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Rose Medical Center

    Denver, Colorado, 80220

  • Western Surgical Care

    Denver, Colorado, 80220

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • Epic Care-Dublin

    Dublin, California, 94568

  • Columbus Oncology and Hematology Associates

    Dublin, Ohio, 43016

  • Dublin Methodist Hospital

    Dublin, Ohio, 43016

  • Northside Hospital - Duluth

    Duluth, Georgia, 30096

  • Northwest Oncology LLC

    Dyer, Indiana, 46311

  • Henry Ford River District Hospital

    East China, Michigan, 48054

  • Fox Chase Cancer Center - East Norriton Hospital Outpatient Center

    East Norriton, Pennsylvania, 19401

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • University of Maryland Shore Medical Center at Easton

    Easton, Maryland, 21601

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608

  • Mountain Blue Cancer Care Center - Swedish

    Englewood, Colorado, 80113

  • Rocky Mountain Cancer Centers - Swedish

    Englewood, Colorado, 80113

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • The Melanoma and Skin Cancer Institute

    Englewood, Colorado, 80113

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Main Line Health Center-Exton

    Exton, Pennsylvania, 19341

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Augusta Health Center for Cancer and Blood Disorders

    Fishersville, Virginia, 22939

  • Cancer Hematology Centers - Flint

    Flint, Michigan, 48503

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Aurora Health Center-Fond du Lac

    Fond du Lac, Wisconsin, 54937

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • Central Ohio Breast and Endocrine Surgery

    Gahanna, Ohio, 43230

  • UF Health Cancer Institute - Gainesville

    Gainesville, Florida, 32610

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

  • Tidelands Georgetown Memorial Hospital

    Georgetown, South Carolina, 29440

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • MultiCare Gig Harbor Medical Park

    Gig Harbor, Washington, 98335

  • National Jewish Health-Western Hematology Oncology

    Golden, Colorado, 80401

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81501

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

  • Banner North Colorado Medical Center

    Greeley, Colorado, 80631

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646

  • Baptist Cancer Center-Grenada

    Grenada, Mississippi, 38901

  • Henry Ford Saint John Hospital - Academic

    Grosse Pointe Woods, Michigan, 48236

  • Henry Ford Saint John Hospital - Breast

    Grosse Pointe Woods, Michigan, 48236

  • Henry Ford Saint John Hospital - Van Elslander

    Grosse Pointe Woods, Michigan, 48236

  • Mount Carmel Grove City Hospital

    Grove City, Ohio, 43123

  • The Cancer Institute of New Jersey Hamilton

    Hamilton, New Jersey, 08690

  • Lehigh Valley Hospital-Hazleton

    Hazleton, Pennsylvania, 18201

  • Cancer and Blood Specialists-Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada-Horizon Ridge

    Henderson, Nevada, 89052

  • Las Vegas Cancer Center-Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada-Southeast Henderson

    Henderson, Nevada, 89074

  • Las Vegas Urology - Green Valley

    Henderson, Nevada, 89074

  • Las Vegas Urology - Pebble

    Henderson, Nevada, 89074

  • Oncology Las Vegas - Henderson

    Henderson, Nevada, 89074

  • Urology Specialists of Nevada - Green Valley

    Henderson, Nevada, 89074

  • South Carolina Cancer Specialists PC

    Hilton Head Island, South Carolina, 29926-3827

  • Northwest Cancer Center - Hobart

    Hobart, Indiana, 46342

  • Saint Mary Medical Center

    Hobart, Indiana, 46342

  • Terrebonne General Medical Center

    Houma, Louisiana, 70360

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • Sidney and Lois Eskenazi Hospital

    Indianapolis, Indiana, 46202

  • Springmill Medical Center

    Indianapolis, Indiana, 46290

  • Saint Catherine Hospital

    Indianapolis, Indiana, 46312

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

  • MU Health Care Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

    Jonesboro, Arkansas, 72401

  • Freeman Health System

    Joplin, Missouri, 64804

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Beacon Kalamazoo Cancer Center

    Kalamazoo, Michigan, 49009

  • Beacon Kalamazoo

    Kalamazoo, Michigan, 49048

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Kingman Regional Medical Center

    Kingman, Arizona, 86401

  • Providence Regional Cancer System-Lacey

    Lacey, Washington, 98503

  • Good Samaritan Hospital - Cancer Centers of Colorado

    Lafayette, Colorado, 80026

  • Rocky Mountain Cancer Centers-Lakewood

    Lakewood, Colorado, 80228

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

  • Las Vegas Urology - Pecos

    Las Vegas, Nevada, 89074

  • Desert West Surgery

    Las Vegas, Nevada, 89102

  • OptumCare Cancer Care at Charleston

    Las Vegas, Nevada, 89102

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Hope Cancer Care of Nevada

    Las Vegas, Nevada, 89103

  • Radiation Oncology Centers of Nevada Central

    Las Vegas, Nevada, 89106

  • Urology Specialists of Nevada - Central

    Las Vegas, Nevada, 89106

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109

  • Las Vegas Prostate Cancer Center

    Las Vegas, Nevada, 89113

  • Las Vegas Urology - Sunset

    Las Vegas, Nevada, 89113

  • Urology Specialists of Nevada - Southwest

    Las Vegas, Nevada, 89113

  • Radiation Oncology Centers of Nevada Southeast

    Las Vegas, Nevada, 89119

  • Ann M Wierman MD LTD

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada - Northwest

    Las Vegas, Nevada, 89128

  • Las Vegas Urology - Cathedral Rock

    Las Vegas, Nevada, 89128

  • Las Vegas Urology - Smoke Ranch

    Las Vegas, Nevada, 89128

  • Oncology Las Vegas - Tenaya

    Las Vegas, Nevada, 89128

  • OptumCare Cancer Care at MountainView

    Las Vegas, Nevada, 89128

  • Urology Specialists of Nevada - Northwest

    Las Vegas, Nevada, 89128

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada, 89135

  • Comprehensive Cancer Centers of Nevada - Town Center

    Las Vegas, Nevada, 89144

  • Comprehensive Cancer Centers of Nevada-Summerlin

    Las Vegas, Nevada, 89144

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada, 89144

  • Las Vegas Cancer Center-Medical Center

    Las Vegas, Nevada, 89148-2405

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89169

  • University Cancer Center

    Las Vegas, Nevada, 89169

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89183

  • Northside Hospital - Gwinnett

    Lawrenceville, Georgia, 30046

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Saint Rita's Medical Center

    Lima, Ohio, 45801

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado, 80120

  • Hope Cancer Clinic

    Livonia, Michigan, 48154

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • PeaceHealth Saint John Medical Center

    Longview, Washington, 98632

  • Banner North Colorado Medical Center - Loveland Campus

    Loveland, Colorado, 80539

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Henry Ford Saint John Hospital - Macomb Medical

    Macomb, Michigan, 48044

  • Henry Ford Warren Hospital - Breast Macomb

    Macomb, Michigan, 48044

  • OhioHealth Mansfield Hospital

    Mansfield, Ohio, 44903

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

  • OhioHealth Marion General Hospital

    Marion, Ohio, 43302

  • Saint Mary's Oncology/Hematology Associates of Marlette

    Marlette, Michigan, 48453

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Bon Secours Memorial Regional Medical Center

    Mechanicsville, Virginia, 23116

  • Riddle Memorial Hospital

    Media, Pennsylvania, 19063

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

  • Baptist Memorial Hospital for Women

    Memphis, Tennessee, 38120

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

  • UH Seidman Cancer Center at Southwest General Hospital

    Middleburg Heights, Ohio, 44130

  • Bon Secours Westchester Emergency Center

    Midlothian, Virginia, 23113

  • Bon Secours Saint Francis Medical Center

    Midlothian, Virginia, 23114

  • Beebe South Coastal Health Campus

    Millville, Delaware, 19967

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • SSM Health Good Samaritan

    Mount Vernon, Illinois, 62864

Other trials in United States

About this study

Official title: Prospective Validation Trial of Taxane Therapy (Docetaxel or Weekly Paclitaxel) and Risk of Chemotherapy-Induced Peripheral Neuropathy in African American Women

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

  1. Assess the ability of the high-risk genotype to predict TIPN risk for docetaxel.

CORRELATIVE STUDY OBJECTIVES:

  1. 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:

  1. 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.

  1. 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.

Being tested
Docetaxel, Paclitaxel, Quality-of-Life Assessment, Questionnaire Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Also called Docecad, RP 56976, RP-56976, RP56976

    Given IV

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT04001829
Study groupRoleWhat they receive
Arm A (paclitaxel)ExperimentalPatients 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.
Receives: Drug: Paclitaxel; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm B (docetaxel)ExperimentalPatients 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.
Receives: Drug: Docetaxel; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Grade 2-4 Taxane-Induced Peripheral Neuropathy (TIPN) by Genotype Risk Group in Arm A

    Grade 2-4 TIPN was assessed by treating physician using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. All patients who started protocol therapy on arm A (paclitaxel) were included in the analysis. The percentage of participants with grade 2-4 TIPN was calculated based on binomial distribution and was compared between high-risk vs low-risk genotype groups using Fisher exact test. Genotype risk group (high vs. low) was determined by genotyping. High-risk genotype was defined by FCAMR GG genotype (homozygous wild type) or SBF2 mutated. Low-risk genotype was defined by carriage of at least one variant allele in FCAMR (AG or AA) and SBF2 wild-type status.

    Measured: assessed at baseline, an end of each cycle, at 6 months and 1 year post registration

Secondary outcomes (5)

  1. Patient-Reported Neuropathy Score Change Between Baseline and End of Treatment by Genotype Risk Group in Patients on Arm A

    The patient-reported neurotoxicity was assessed using the 11 items about neurotoxicity in the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-Ntx) questionnaire (i.e., FACT/GOG-Ntx additional concerns subscale). The neurotoxicity total score was the sum of the scores for the 11 items, ranging from 0 to 44. Higher values of the FACT/GOG-Ntx neurotoxicity total score indicate less neurotoxicity. The FACT/GOG-Ntx neurotoxicity total score change between the baseline and at end of treatment (negative value indicates worsening symptom, positive value indicates improving symptom) was calculated and compared using two-sample t test. Genotype risk group (high vs. low) was determined by genotyping. High-risk genotype was defined by FCAMR GG genotype (homozygous wild type) or SBF2 mutated. Low-risk genotype was defined by carriage of at least one variant allele in FCAMR (AG or AA) and SBF2 wild-type status.

    Measured: assessed at baseline and at end of treatment, an average of 3 months

  2. Percentage of Participants With Grade 2-4 TIPN Based on CTCAE Between Arm A and Arm B

    Grade 2-4 TIPN was assessed by treating physician using CTCAE version 4.0. All patients who started protocol therapy were included in the analysis. The percentage of participants with grade 2-4 TIPN was calculated based on binomial distribution and was compared between treatment arms using Fisher exact test.

    Measured: assessed at baseline, an end of each cycle, at 6 months and 1 year post registration

  3. Percentage of Participants With Dose Reduction Due to TIPN Between Arm A and Arm B

    The percentage of patients with dose reduction due to TIPN was calculated as number of patients with dose reduction due to peripheral neuropathy for any dose of any cycle divided by total number of patients who started protocol therapy. The percentages were calculated along with exact 95% CI based on binomial distribution and were compared between arms using Fisher exact test.

    Measured: Dose reduction due to TIPN was assessed at end of each cycle, up to 4 cycles in arm A and 6 cycles in arm B

  4. Percentage of Participants With Dose Reduction Due to Any Reason Between Arm A and Arm B

    The percentage of patients with dose reduction due to any reason was calculated as number of patients with any dose reduction for any dose of any cycle, regardless of the reason, divided by total number of patients who started protocol therapy. The percentages were calculated along with exact 95% CI based on binomial distribution and were compared between arms using Fisher exact test.

    Measured: Dose reduction due to any reason was assessed at end of each cycle, up to 4 cycles in arm A and 6 cycles in arm B

  5. Percentage of Participants With Grade 2-4 TIPN by Genotype Risk Group in Arm B

    Grade 2-4 TIPN was assessed by treating physician using CTCAE version 4.0. All patients who started protocol therapy on arm B were included in the analysis. The percentage of participants with grade 2-4 TIPN was calculated based on binomial distribution and was compared between high-risk vs low-risk genotype groups using Fisher exact test. Genotype risk group (high vs. low) was determined by genotyping. High-risk genotype was defined by FCAMR GG genotype (homozygous wild type) or SBF2 mutated. Low-risk genotype was defined by carriage of at least one variant allele in FCAMR (AG or AA) and SBF2 wild-type status.

    Measured: assessed at baseline, at end of each cycle, at 6 months and 1 year post registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2019
  2. Study start9 Aug 2019
  3. Primary completion19 Sep 2023
  4. Study completion5 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
249 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04001829
Sponsor's protocol ID
EAZ171
Other IDs
NCI-2019-00266, EAZ171, ECOG-ACRIN-EAZ171, EAZ171, UG1CA189828
Status last verified
Sep 2026
First submitted
19 Jun 2019
Last updated
6 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38828938

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Paclitaxel and Quality-of-Life Assessment in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by ECOG-ACRIN Cancer Research Group at 482 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 482 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Grade 2-4 Taxane-Induced Peripheral Neuropathy (TIPN) by Genotype Risk Group in Arm A (time frame: assessed at baseline, an end of each cycle, at 6 months and 1 year post registration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04001829, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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