Paclitaxel With or Without Carboplatin and/or Bevacizumab Followed by Doxorubicin and Cyclophosphamide in Treating Patients With Breast Cancer That Can Be Removed by Surgery

February 23, 2024 updated by: National Cancer Institute (NCI)

Randomized Phase II 2 x 2 Factorial Trial of the Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly Paclitaxel Followed by Dose-Dense AC in Hormone Receptor-Poor/HER2-Negative Resectable Breast Cancer

This randomized phase II trial studies how well paclitaxel with or without carboplatin and/or bevacizumab followed by doxorubicin and cyclophosphamide works in treating patients with breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine whether adding bevacizumab to neoadjuvant weekly paclitaxel (+/- carboplatin) and subsequent dose-dense doxorubicin and cyclophosphamide (ddAC) significantly raises the rate of pathologic complete response (pCR) in the breast in patients with hormone receptor (HR)-poor/human epidermal growth factor receptor 2 (HER2) (-), resectable breast cancer.

II. To determine whether adding carboplatin every 3 weeks to neoadjuvant weekly paclitaxel followed by ddAC (+/- bevacizumab) significantly raises the rate of pCR in the breast in patients with HR-poor/HER2(-), resectable breast cancer.

III. To determine whether adding bevacizumab every 2 weeks to neoadjuvant weekly paclitaxel (+/- carboplatin) and subsequent ddAC significantly raises the rate of pCR in the breast in patients with basal-like breast cancers, as defined by gene expression array.

IV. To determine whether adding carboplatin every 3 weeks to neoadjuvant weekly paclitaxel followed by ddAC (+/- bevacizumab) significantly raises the rate of pCR in the breast in patients with basal-like breast cancers, as defined by gene expression array.

SECONDARY OBJECTIVES:

I. To determine the pCR rates in the breast and axilla, using American Joint Committee On Cancer (AJCC) TNM criteria (version 6), to neoadjuvant weekly paclitaxel, with or without carboplatin, followed by ddAC, with or without bevacizumab, given concurrently with the weekly paclitaxel and ddAC, in (a) patients with HR-poor/HER2(-), resectable breast cancer and (b) the subset of patients with basal-like breast cancers, as defined by gene expression array.

II. To assess whether there is an interaction between the addition of carboplatin and bevacizumab to neoadjuvant chemotherapy (NAC) with weekly paclitaxel followed by ddAC as regards the path pCR rates in (a) patients with HR-poor/HER2(-), resectable breast cancer and (b) the subset of patients with basal-like breast cancers, as defined by gene expression array.

III. To assess the toxicity of the control regimen (weekly paclitaxel followed by ddAC) and any incremental toxicities associated with the addition of carboplatin and/or bevacizumab in this patient population, including the incidence of febrile neutropenia, grade >= 3 thrombocytopenia, grade >= 2 neurotoxicity, grade >= 3 hypertension, and clinically significant bleeding or thrombotic (including cardiovascular and cerebrovascular) events.

IV. To determine the recurrence-free survival (RFS) measured from definitive surgery to first event, and time to first failure (TFF) measured from study entry to first event.

V. To determine overall survival (OS), defined as time from registration to death from any cause.

VI. To assess the impact of NAC with weekly paclitaxel followed by ddAC, with or without carboplatin and/or bevacizumab, on axillary lymph node involvement at surgery, particularly in patients with clinically or histologically positive axillary lymph nodes prior to initiation of NAC.

VII. To assess the impact of the addition of bevacizumab to NAC on the incidence and severity of post-op complications, especially excessive bleeding, delayed wound healing, and thrombotic complications.

VIII. To evaluate residual cancer burden (RCB) as a predictor of RFS, TFF and OS.

IX. To determine the correlation between clinical, radiographic, and pathologic response.

TERTIARY OBJECTIVES:

I. To assess whether the impact of the addition of carboplatin and/or bevacizumab to NAC with weekly paclitaxel followed by ddAC on achievement of pathologic CRs in patients with HR-poor/HER2(-), resectable breast cancer is influenced by molecular subtype, as defined by gene expression array.

II. To obtain blood, fresh frozen and fixed tumor tissue to test specific hypotheses for which biomarker data exist and to evaluate biomarkers in tissue, blood, and serum that may influence response to and toxicity of weekly paclitaxel, ddAC, carboplatin, and/or bevacizumab.

III. To obtain blood samples to test specific hypotheses for which biomarker data exist and to evaluate biomarkers in blood that may influence response to and toxicity of weekly paclitaxel, ddAC, carboplatin and/or bevacizumab.

IV. To determine the surgical practice patterns for breast conservation and sentinel lymphadenectomy in patients undergoing neoadjuvant chemotherapy.

V. To examine the practice patterns and use of sentinel lymphadenectomy (pre-chemotherapy or post-chemotherapy) in patients with T2 or T3 breast cancer.

VI. To examine the proportion of patients who presented with T2 or T3 cancers who undergo mastectomy despite cytoreduction adequate for breast conservation.

VII. To determine the radiotherapy practice patterns for post-mastectomy and regional nodal irradiation in patients undergoing neoadjuvant chemotherapy.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 3-10 minutes and cyclophosphamide IV over 5-60 minutes (ddAC) once in weeks 13, 15, 17, and 19.

ARM II: Patients receive paclitaxel and ddAC as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes once in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.

ARM III: Patients receive paclitaxel and ddAC as in Arm I. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.

ARM IV: Patients receive paclitaxel and ddAC as in Arm I, bevacizumab as in Arm II, and carboplatin as in Arm III.

Patients in all arms undergo definitive surgery (i.e., modified radical mastectomy or breast-conserving surgery with appropriate management of the axilla) between 4-8 weeks after completion of neoadjuvant therapy.

After completion of study treatment, patients are followed up periodically for up to 10 years.

Study Type

Interventional

Enrollment (Actual)

454

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
      • Jonesboro, Arkansas, United States, 72401
        • NEA Baptist Memorial Hospital
      • Rogers, Arkansas, United States, 72758
        • Highlands Oncology Group - Rogers
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Burlingame, California, United States, 94010
        • Mills-Peninsula Medical Center
      • Castro Valley, California, United States, 94546
        • Eden Hospital Medical Center
      • Castro Valley, California, United States, 94546
        • East Bay Radiation Oncology Center
      • Castro Valley, California, United States, 94546
        • Valley Medical Oncology Consultants-Castro Valley
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Cancer Center
      • Emeryville, California, United States, 94608
        • Bay Area Breast Surgeons Inc
      • Emeryville, California, United States, 94608
        • Epic Care Partners in Cancer Care
      • Fremont, California, United States, 94538
        • Valley Medical Oncology Consultants-Fremont
      • Martinez, California, United States, 94553-3156
        • Contra Costa Regional Medical Center
      • Mountain View, California, United States, 94040
        • El Camino Hospital
      • Mountain View, California, United States, 94040
        • Palo Alto Medical Foundation-Camino Division
      • Novato, California, United States, 94945
        • Sutter Cancer Research Consortium
      • Oakland, California, United States, 94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland, California, United States, 94609
        • Hematology and Oncology Associates-Oakland
      • Oakland, California, United States, 94602
        • Highland General Hospital
      • Oakland, California, United States, 94609
        • Tom K Lee Inc
      • Oakland, California, United States, 94609
        • Bay Area Tumor Institute
      • Orange, California, United States, 92868
        • Saint Joseph Hospital - Orange
      • Palm Springs, California, United States, 92262
        • Desert Regional Medical Center
      • Palo Alto, California, United States, 94301
        • Palo Alto Medical Foundation Health Care
      • Pleasanton, California, United States, 94588
        • Valley Care Health System - Pleasanton
      • Pleasanton, California, United States, 94588
        • Valley Medical Oncology Consultants
      • Salinas, California, United States, 93901
        • Salinas Valley Memorial
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center-Pacific Campus
      • San Pablo, California, United States, 94806
        • Doctors Medical Center- JC Robinson Regional Cancer Center
      • Santa Ana, California, United States, 92705
        • Breastlink Medical Group Inc
      • Santa Rosa, California, United States, 95403
        • Sutter Pacific Medical Foundation
      • Vallejo, California, United States, 94589
        • Sutter Solano Medical Center/Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80012
        • The Medical Center of Aurora
      • Boulder, Colorado, United States, 80301
        • Boulder Community Hospital
      • Colorado Springs, Colorado, United States, 80907
        • Penrose-Saint Francis Healthcare
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, United States, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, United States, 80218
        • SCL Health Saint Joseph Hospital
      • Denver, Colorado, United States, 80220
        • Rose Medical Center
      • Denver, Colorado, United States, 80222
        • Western States Cancer Research NCORP
      • Englewood, Colorado, United States, 80113
        • Swedish Medical Center
      • Fort Collins, Colorado, United States, 80524
        • Poudre Valley Hospital
      • Grand Junction, Colorado, United States, 81501
        • Saint Mary's Hospital and Regional Medical Center
      • Greeley, Colorado, United States, 80631
        • North Colorado Medical Center
      • Lakewood, Colorado, United States, 80228
        • Saint Anthony Hospital
      • Littleton, Colorado, United States, 80122
        • Littleton Adventist Hospital
      • Lone Tree, Colorado, United States, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, United States, 80501
        • Longmont United Hospital
      • Loveland, Colorado, United States, 80539
        • McKee Medical Center
      • Parker, Colorado, United States, 80138
        • Parker Adventist Hospital
      • Pueblo, Colorado, United States, 81004
        • Saint Mary Corwin Medical Center
      • Thornton, Colorado, United States, 80229
        • North Suburban Medical Center
      • Wheat Ridge, Colorado, United States, 80033
        • SCL Health Lutheran Medical Center
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Hartford HealthCare - Saint Vincent's Medical Center
      • Greenwich, Connecticut, United States, 06830
        • Greenwich Hospital
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • Manchester, Connecticut, United States, 06040
        • Manchester Memorial Hospital
      • Norwalk, Connecticut, United States, 06856
        • Norwalk Hospital
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Beebe Medical Center
      • Newark, Delaware, United States, 19718
        • Christiana Care Health System-Christiana Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital
      • Washington, District of Columbia, United States, 20016
        • Sibley Memorial Hospital
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
      • Jupiter, Florida, United States, 33458
        • Jupiter Medical Center
      • Lake Worth, Florida, United States, 33461
        • Cancer Center of South Florida-Lake Worth
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando
    • Georgia
      • Albany, Georgia, United States, 31701
        • Phoebe Putney Memorial Hospital
      • Atlanta, Georgia, United States, 30342
        • Emory Saint Joseph's Hospital
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
      • Atlanta, Georgia, United States, 30342
        • Atlanta Regional CCOP
      • Austell, Georgia, United States, 30106
        • WellStar Cobb Hospital
      • Columbus, Georgia, United States, 31904
        • John B Amos Cancer Center
      • Decatur, Georgia, United States, 30033
        • Dekalb Medical Center
      • Fayetteville, Georgia, United States, 30214
        • Piedmont Fayette Hospital
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center-Gainesville
      • Lawrenceville, Georgia, United States, 30046
        • Northside Hospital - Gwinnett
      • Marietta, Georgia, United States, 30060
        • Wellstar Kennestone Hospital
      • Riverdale, Georgia, United States, 30274
        • Southern Regional Medical Center
      • Rome, Georgia, United States, 30165
        • Harbin Clinic Medical Oncology and Clinical Research
      • Savannah, Georgia, United States, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
      • Savannah, Georgia, United States, 31404
        • Memorial Health University Medical Center
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Pali Momi Medical Center
      • Honolulu, Hawaii, United States, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, United States, 96817
        • The Cancer Center of Hawaii-Liliha
      • Honolulu, Hawaii, United States, 96813
        • Hawaii Cancer Care Inc - Waterfront Plaza
      • Honolulu, Hawaii, United States, 96813
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, United States, 96813
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, United States, 96817
        • Hawaii Cancer Care Inc-Liliha
      • Honolulu, Hawaii, United States, 96817
        • Queen's Cancer Center - Kuakini
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center for Women and Children
      • Kailua, Hawaii, United States, 96734
        • Castle Medical Center
      • Lihue, Hawaii, United States, 96766
        • Wilcox Memorial Hospital and Kauai Medical Clinic
      • Wailuku, Hawaii, United States, 96793
        • Maui Memorial Medical Center
      • Wailuku, Hawaii, United States, 96793
        • Pacific Cancer Institute of Maui
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, United States, 60612
        • University of Illinois
      • Chicago, Illinois, United States, 60612
        • John H Stroger Jr Hospital of Cook County
      • Chicago, Illinois, United States, 60608
        • Mount Sinai Hospital Medical Center
      • Chicago, Illinois, United States, 60631
        • Presence Resurrection Medical Center
      • Chicago, Illinois, United States, 60640
        • Weiss Memorial Hospital
      • Downers Grove, Illinois, United States, 60515
        • Advocate Good Samaritan Hospital
      • La Grange, Illinois, United States, 60525
        • AMITA Health Adventist Medical Center
      • River Forest, Illinois, United States, 60305
        • West Suburban Medical Center
      • Rockford, Illinois, United States, 61104
        • Swedish American Hospital
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • Franciscan Saint Francis Health-Beech Grove
      • Elkhart, Indiana, United States, 46515
        • Elkhart General Hospital
      • Elkhart, Indiana, United States, 46514
        • Michiana Hematology Oncology PC-Elkhart
      • Elkhart, Indiana, United States, 46514-2098
        • Elkhart Clinic
      • Fort Wayne, Indiana, United States, 46845
        • Fort Wayne Medical Oncology and Hematology Inc-Parkview
      • Kokomo, Indiana, United States, 46904
        • Community Howard Regional Health
      • La Porte, Indiana, United States, 46350
        • IU Health La Porte Hospital
      • Mishawaka, Indiana, United States, 46545
        • Michiana Hematology Oncology PC-Mishawaka
      • Mishawaka, Indiana, United States, 46545
        • Saint Joseph Regional Medical Center-Mishawaka
      • Plymouth, Indiana, United States, 46563
        • Michiana Hematology Oncology PC-Plymouth
      • Richmond, Indiana, United States, 47374
        • Reid Health
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, United States, 46601
        • Michiana Hematology Oncology PC-South Bend
      • South Bend, Indiana, United States, 46628
        • Northern Indiana Cancer Research Consortium
      • South Bend, Indiana, United States, 46617
        • South Bend Clinic
      • Westville, Indiana, United States, 46391
        • Michiana Hematology Oncology PC-Westville
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
        • Mercy Hospital
      • Cedar Rapids, Iowa, United States, 52402
        • Saint Luke's Hospital
      • Cedar Rapids, Iowa, United States, 52402
        • Physicians' Clinic of Iowa PC
      • Iowa City, Iowa, United States, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
      • Sioux City, Iowa, United States, 51101
        • Siouxland Regional Cancer Center
      • Sioux City, Iowa, United States, 51102
        • Mercy Medical Center-Sioux City
      • Sioux City, Iowa, United States, 51104
        • Saint Luke's Regional Medical Center
    • Kansas
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, United States, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas - El Dorado
      • Fort Scott, Kansas, United States, 66701
        • Cancer Center of Kansas - Fort Scott
      • Hays, Kansas, United States, 67601
        • HaysMed University of Kansas Health System
      • Hutchinson, Kansas, United States, 67502
        • Hutchinson Regional Medical Center
      • Independence, Kansas, United States, 67301
        • Cancer Center of Kansas-Independence
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas-Kingman
      • Lawrence, Kansas, United States, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, United States, 67905
        • Cancer Center of Kansas-Liberal
      • McPherson, Kansas, United States, 67460
        • Cancer Center of Kansas - McPherson
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas - Newton
      • Overland Park, Kansas, United States, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, United States, 66213
        • Saint Luke's South Hospital
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas - Parsons
      • Pittsburg, Kansas, United States, 66762
        • Ascension Via Christi - Pittsburg
      • Prairie Village, Kansas, United States, 66208
        • Kansas City NCI Community Oncology Research Program
      • Pratt, Kansas, United States, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, United States, 67401
        • Salina Regional Health Center
      • Salina, Kansas, United States, 67401
        • Cancer Center of Kansas - Salina
      • Shawnee Mission, Kansas, United States, 66204
        • Advent Health - Shawnee Mission Medical Center
      • Topeka, Kansas, United States, 66606
        • University of Kansas Health System Saint Francis Campus
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, United States, 67214
        • Ascension Via Christi Hospitals Wichita
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas - Wichita
      • Wichita, Kansas, United States, 67208
        • Associates In Womens Health
      • Wichita, Kansas, United States, 67214
        • Wichita NCI Community Oncology Research Program
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas - Winfield
    • Maine
      • Bangor, Maine, United States, 04401
        • Eastern Maine Medical Center
      • Scarborough, Maine, United States, 04074
        • Maine Center for Cancer Medicine-Scarborough
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • MedStar Franklin Square Medical Center/Weinberg Cancer Institute
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center
      • Baltimore, Maryland, United States, 21201
        • University of Maryland/Greenebaum Cancer Center
      • Bethesda, Maryland, United States, 20889-5600
        • Walter Reed National Military Medical Center
      • Elkton, Maryland, United States, 21921
        • Christiana Care - Union Hospital
      • Frederick, Maryland, United States, 21701
        • Frederick Memorial Hospital
      • Salisbury, Maryland, United States, 21801
        • TidalHealth Peninsula Regional
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital and Medical Center
      • Gloucester, Massachusetts, United States, 01930
        • Addison Gilbert Hospital
      • Milford, Massachusetts, United States, 01757
        • Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
      • Newton, Massachusetts, United States, 02462
        • Newton-Wellesley Hospital
    • Michigan
      • Adrian, Michigan, United States, 49221
        • Bixby Medical Center
      • Adrian, Michigan, United States, 49221
        • Hickman Cancer Center
      • Escanaba, Michigan, United States, 49829
        • Green Bay Oncology - Escanaba
      • Iron Mountain, Michigan, United States, 49801
        • Green Bay Oncology - Iron Mountain
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, United States, 49048
        • Borgess Medical Center
      • Midland, Michigan, United States, 48670
        • MyMichigan Medical Center Midland
      • Monroe, Michigan, United States, 48162
        • Mercy Memorial Hospital
      • Monroe, Michigan, United States, 48162
        • Toledo Clinic Cancer Centers-Monroe
      • Niles, Michigan, United States, 49120
        • Corewell Health Lakeland Hospitals - Niles Hospital
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Medical Center Saint Joseph
      • Saint Joseph, Michigan, United States, 49085
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Cancer Center
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Saint Mary's Medical Center
      • Duluth, Minnesota, United States, 55805
        • Miller-Dwan Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Unity Hospital
      • Hutchinson, Minnesota, United States, 55350
        • Hutchinson Area Health Care
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • New Ulm, Minnesota, United States, 56073
        • New Ulm Medical Center
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Health Center
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Louis Park, Minnesota, United States, 55416
        • Metro Minnesota Community Oncology Research Consortium
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Shakopee, Minnesota, United States, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, United States, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology PA-Woodbury
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Bolivar, Missouri, United States, 65613
        • Central Care Cancer Center - Bolivar
      • Branson, Missouri, United States, 65616
        • Cox Cancer Center Branson
      • Cape Girardeau, Missouri, United States, 63703
        • Southeast Cancer Center
      • Chesterfield, Missouri, United States, 63017
        • Saint Luke's Hospital
      • Columbia, Missouri, United States, 65212
        • MU Health - University Hospital/Ellis Fischel Cancer Center
      • Jefferson City, Missouri, United States, 65109
        • Capital Region Southwest Campus
      • Kansas City, Missouri, United States, 64116
        • North Kansas City Hospital
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • Kansas City, Missouri, United States, 64108
        • Truman Medical Centers
      • Kansas City, Missouri, United States, 64118
        • Heartland Hematology and Oncology Associates Incorporated
      • Kansas City, Missouri, United States, 64114
        • Saint Joseph Health Center
      • Lee's Summit, Missouri, United States, 64086
        • Saint Luke's East - Lee's Summit
      • Liberty, Missouri, United States, 64068
        • Liberty Radiation Oncology Center
      • Rolla, Missouri, United States, 65401
        • Delbert Day Cancer Institute at PCRMC
      • Rolla, Missouri, United States, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Saint Joseph, Missouri, United States, 64506
        • Heartland Regional Medical Center
      • Saint Joseph, Missouri, United States, 64507
        • Saint Joseph Oncology Inc
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
      • Saint Louis, Missouri, United States, 63104
        • SSM Health Saint Louis University Hospital
      • Saint Louis, Missouri, United States, 63141
        • Center for Cancer Care and Research
      • Saint Louis, Missouri, United States, 63141
        • Comprehensive Cancer Care PC
      • Springfield, Missouri, United States, 65804
        • Cancer Research for the Ozarks NCORP
      • Springfield, Missouri, United States, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
      • Billings, Montana, United States, 59101
        • Saint Vincent Healthcare
      • Billings, Montana, United States, 59102
        • Montana Cancer Consortium NCORP
      • Billings, Montana, United States, 59102
        • Saint Vincent Frontier Cancer Center
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Hospital
      • Butte, Montana, United States, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic
      • Great Falls, Montana, United States, 59405
        • Benefis Healthcare- Sletten Cancer Institute
      • Havre, Montana, United States, 59501
        • Northern Montana Hospital
      • Helena, Montana, United States, 59601
        • Saint Peter's Community Hospital
      • Kalispell, Montana, United States, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, United States, 59901
        • Glacier Oncology PLLC
      • Kalispell, Montana, United States, 59901
        • Kalispell Medical Oncology
      • Missoula, Montana, United States, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, United States, 59802
        • Montana Cancer Specialists
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • New Hampshire Oncology Hematology PA-Concord
      • Exeter, New Hampshire, United States, 03833
        • Exeter Hospital
      • Laconia, New Hampshire, United States, 03246
        • LRGHealthcare-Lakes Region General Hospital
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
      • Manchester, New Hampshire, United States, 03102
        • Norris Cotton Cancer Center-Manchester
      • Manchester, New Hampshire, United States, 03103
        • Solinsky Center for Cancer Care
      • Manchester, New Hampshire, United States, 03103
        • Elliot Hospital
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Hospital University Medical Center
      • Long Branch, New Jersey, United States, 07740
        • Monmouth Medical Center
      • Mount Holly, New Jersey, United States, 08060
        • Virtua Memorial
      • Newark, New Jersey, United States, 07101
        • Rutgers New Jersey Medical School
      • Voorhees, New Jersey, United States, 08043
        • Virtua Voorhees
    • New York
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center
      • Brooklyn, New York, United States, 11235
        • Coney Island Hospital
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • East Syracuse, New York, United States, 13057
        • Hematology Oncology Associates of Central New York-East Syracuse
      • Elmhurst, New York, United States, 11373
        • Elmhurst Hospital Center
      • Glens Falls, New York, United States, 12801
        • Glens Falls Hospital
      • Jamaica, New York, United States, 11432
        • Queens Hospital Center
      • Middletown, New York, United States, 10940
        • Garnet Health Medical Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10019
        • Mount Sinai West
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
      • New York, New York, United States, 10003
        • Mount Sinai Union Square
      • Staten Island, New York, United States, 10305
        • Staten Island University Hospital
      • Syracuse, New York, United States, 13210
        • State University of New York Upstate Medical University
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Randolph Hospital
      • Asheville, North Carolina, United States, 28801
        • Mission Hospital
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Presbyterian Medical Center
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital
      • Greensboro, North Carolina, United States, 27403
        • Cone Health Cancer Center
      • Kinston, North Carolina, United States, 28501
        • Vidant Oncology-Kinston
      • Pinehurst, North Carolina, United States, 28374
        • FirstHealth of the Carolinas-Moore Regional Hospital
      • Raleigh, North Carolina, United States, 27607
        • UNC Rex Healthcare
      • Reidsville, North Carolina, United States, 27320
        • Annie Penn Memorial Hospital
      • Rocky Mount, North Carolina, United States, 27804
        • Nash General Hospital
      • Rutherfordton, North Carolina, United States, 28139
        • Rutherford Hospital
      • Statesville, North Carolina, United States, 28677
        • Iredell Memorial Hospital
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Forsyth Medical Center
      • Winston-Salem, North Carolina, United States, 27104
        • Southeast Clinical Oncology Research Consortium NCORP
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • Altru Cancer Center
    • Ohio
      • Akron, Ohio, United States, 44307
        • Cleveland Clinic Akron General
      • Akron, Ohio, United States, 44304
        • Summa Health System - Akron Campus
      • Barberton, Ohio, United States, 44203
        • Summa Health System - Barberton Campus
      • Bowling Green, Ohio, United States, 43402
        • Toledo Clinic Cancer Centers-Bowling Green
      • Canton, Ohio, United States, 44710
        • Aultman Health Foundation
      • Clyde, Ohio, United States, 43410
        • North Coast Cancer Care-Clyde
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
      • Dayton, Ohio, United States, 45406
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, United States, 45415
        • Miami Valley Hospital North
      • Dayton, Ohio, United States, 45405
        • Grandview Hospital
      • Dayton, Ohio, United States, 45459
        • Dayton NCI Community Oncology Research Program
      • Elyria, Ohio, United States, 44035
        • Mercy Cancer Center-Elyria
      • Elyria, Ohio, United States, 44035
        • Hematology Oncology Center Incorporated
      • Findlay, Ohio, United States, 45840
        • Blanchard Valley Hospital
      • Franklin, Ohio, United States, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Greenville, Ohio, United States, 45331
        • Wayne Hospital
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center
      • Lima, Ohio, United States, 45801
        • Saint Rita's Medical Center
      • Lima, Ohio, United States, 45804
        • Lima Memorial Hospital
      • Mansfield, Ohio, United States, 44903
        • OhioHealth Mansfield Hospital
      • Maumee, Ohio, United States, 43537
        • Toledo Clinic Cancer Centers-Maumee
      • Maumee, Ohio, United States, 43537
        • Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
      • Maumee, Ohio, United States, 43537
        • Saint Luke's Hospital
      • Norwalk, Ohio, United States, 44857
        • Fisher-Titus Medical Center
      • Oregon, Ohio, United States, 43616
        • Saint Charles Hospital
      • Oregon, Ohio, United States, 43616
        • Toledo Clinic Cancer Centers-Oregon
      • Sandusky, Ohio, United States, 44870
        • North Coast Cancer Care
      • Sylvania, Ohio, United States, 43560
        • ProMedica Flower Hospital
      • Tiffin, Ohio, United States, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, United States, 43606
        • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
      • Toledo, Ohio, United States, 43608
        • Saint Vincent Mercy Medical Center
      • Toledo, Ohio, United States, 43623
        • Mercy Health - Saint Anne Hospital
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic Cancer Centers-Toledo
      • Toledo, Ohio, United States, 43614
        • University of Toledo
      • Toledo, Ohio, United States, 43617
        • Toledo Community Hospital Oncology Program CCOP
      • Troy, Ohio, United States, 45373
        • Upper Valley Medical Center
      • Wauseon, Ohio, United States, 43567
        • Fulton County Health Center
      • Wilmington, Ohio, United States, 45177
        • Clinton Memorial Hospital
      • Xenia, Ohio, United States, 45385
        • Greene Memorial Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, United States, 73142
        • Integris Cancer Institute of Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Cancer Care Associates
    • Oregon
      • Coos Bay, Oregon, United States, 97420
        • Bay Area Hospital
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Saint Luke's University Hospital-Bethlehem Campus
      • Butler, Pennsylvania, United States, 16001
        • Butler Memorial Hospital
      • Gettysburg, Pennsylvania, United States, 17325
        • Adams Cancer Center
      • Hanover, Pennsylvania, United States, 17331
        • Cherry Tree Cancer Center
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Lewistown, Pennsylvania, United States, 17044
        • Lewistown Hospital
      • Philadelphia, Pennsylvania, United States, 19114
        • Jefferson Torresdale Hospital
      • Philadelphia, Pennsylvania, United States, 19141
        • Einstein Medical Center Philadelphia
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Medical Group PC-Robert Packer Hospital
      • State College, Pennsylvania, United States, 16803
        • Mount Nittany Medical Center
      • York, Pennsylvania, United States, 17403
        • WellSpan Health-York Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital
      • Providence, Rhode Island, United States, 02906
        • Miriam Hospital
      • Warwick, Rhode Island, United States, 02886
        • Kent Hospital
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Cancer Center
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Hospital
      • Boiling Springs, South Carolina, United States, 29316
        • Prisma Health Cancer Institute - Spartanburg
      • Charleston, South Carolina, United States, 29401
        • Roper Hospital
      • Easley, South Carolina, United States, 29640
        • Prisma Health Cancer Institute - Easley
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, United States, 29615
        • Prisma Health Cancer Institute - Eastside
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Cancer Institute - Butternut
      • Greenville, South Carolina, United States, 29601
        • Saint Francis Hospital
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Greenville Memorial Hospital
      • Greenwood, South Carolina, United States, 29646
        • Self Regional Healthcare
      • Greer, South Carolina, United States, 29650
        • Prisma Health Cancer Institute - Greer
      • Seneca, South Carolina, United States, 29672
        • Prisma Health Cancer Institute - Seneca
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Center
      • West Columbia, South Carolina, United States, 29169
        • Lexington Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, United States, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center Oncology Clinic
      • Sioux Falls, South Dakota, United States, 57105
        • Medical X-Ray Center
      • Sioux Falls, South Dakota, United States, 57117-5045
        • Avera McKennan Hospital and University Health Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Medical Center
      • Knoxville, Tennessee, United States, 37916
        • Thompson Cancer Survival Center
      • Nashville, Tennessee, United States, 37208
        • Meharry Medical College
      • Nashville, Tennessee, United States, 37203
        • Nashville Oncology Associates PC
    • Texas
      • Laredo, Texas, United States, 78041
        • Doctor's Hospital of Laredo
      • Lubbock, Texas, United States, 79430
        • Texas Tech University Health Sciences Center-Lubbock
    • Utah
      • American Fork, Utah, United States, 84003
        • American Fork Hospital / Huntsman Intermountain Cancer Center
      • Cedar City, Utah, United States, 84720
        • Sandra L Maxwell Cancer Center
      • Logan, Utah, United States, 84321
        • Logan Regional Hospital
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
      • Ogden, Utah, United States, 84403
        • McKay-Dee Hospital Center
      • Provo, Utah, United States, 84604
        • Utah Valley Regional Medical Center
      • Saint George, Utah, United States, 84770
        • Saint George Regional Medical Center
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists-Salt Lake City
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
      • Salt Lake City, Utah, United States, 84103
        • Intermountain Health Care
    • Virginia
      • Fredericksburg, Virginia, United States, 22401
        • Fredericksburg Oncology Inc
      • Fredericksburg, Virginia, United States, 22408
        • Hematology Oncology Associates of Fredericksburg Inc
      • Hampton, Virginia, United States, 23666
        • Virginia Oncology Associates-Hampton
    • Washington
      • Anacortes, Washington, United States, 98221
        • Cancer Care Center at Island Hospital
      • Auburn, Washington, United States, 98001
        • MultiCare Auburn Medical Center
      • Bellingham, Washington, United States, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Bremerton, Washington, United States, 98310
        • Harrison HealthPartners Hematology and Oncology-Bremerton
      • Burien, Washington, United States, 98166
        • Highline Medical Center-Main Campus
      • Centralia, Washington, United States, 98531
        • Providence Regional Cancer System-Centralia
      • Federal Way, Washington, United States, 98003
        • Saint Francis Hospital
      • Issaquah, Washington, United States, 98029
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, United States, 99336
        • Kadlec Clinic Hematology and Oncology
      • Lakewood, Washington, United States, 98499
        • Saint Clare Hospital
      • Mount Vernon, Washington, United States, 98274
        • Skagit Valley Hospital
      • Olympia, Washington, United States, 98506-5166
        • Providence - Saint Peter Hospital
      • Poulsbo, Washington, United States, 98370
        • Harrison HealthPartners Hematology and Oncology-Poulsbo
      • Puyallup, Washington, United States, 98372
        • MultiCare Good Samaritan Hospital
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center-First Hill
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center - Montlake
      • Seattle, Washington, United States, 98112
        • Kaiser Permanente Washington
      • Seattle, Washington, United States, 98104
        • Minor and James Medical PLLC
      • Sedro-Woolley, Washington, United States, 98284
        • PeaceHealth United General Medical Center
      • Spokane, Washington, United States, 99218
        • Evergreen Hematology and Oncology PS
      • Spokane, Washington, United States, 99202
        • Cancer Care Northwest - Spokane South
      • Tacoma, Washington, United States, 98405
        • MultiCare Tacoma General Hospital
      • Tacoma, Washington, United States, 98405
        • MultiCare Allenmore Hospital
      • Tacoma, Washington, United States, 98405
        • Northwest NCI Community Oncology Research Program
      • Tacoma, Washington, United States, 98405
        • Saint Joseph Medical Center
      • Walla Walla, Washington, United States, 99362
        • Providence Saint Mary Regional Cancer Center
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Hospital and Clinics
    • West Virginia
      • Huntington, West Virginia, United States, 25702
        • Saint Mary's Medical Center
      • Princeton, West Virginia, United States, 24740
        • Princeton Community Hospital
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • ThedaCare Regional Cancer Center
      • Appleton, Wisconsin, United States, 54911
        • Fox Valley Surgical Associates Limited
      • Burlington, Wisconsin, United States, 53105
        • Aurora Cancer Care-Southern Lakes VLCC
      • Franklin, Wisconsin, United States, 53132
        • Aurora Cancer Care-Franklin
      • Germantown, Wisconsin, United States, 53022
        • Aurora Health Care Germantown Health Center
      • Glendale, Wisconsin, United States, 53212
        • Aurora Cancer Care-Glendale
      • Green Bay, Wisconsin, United States, 54311
        • Aurora BayCare Medical Center
      • Green Bay, Wisconsin, United States, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, United States, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • Green Bay, Wisconsin, United States, 54303
        • Green Bay Oncology Limited at Saint Mary's Hospital
      • Green Bay, Wisconsin, United States, 54301-3526
        • Green Bay Oncology at Saint Vincent Hospital
      • Kenosha, Wisconsin, United States, 53142
        • Aurora Cancer Care-Kenosha South
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center
      • Manitowoc, Wisconsin, United States, 54221
        • Holy Family Memorial Hospital
      • Marinette, Wisconsin, United States, 54143
        • Aurora Bay Area Medical Group-Marinette
      • Marinette, Wisconsin, United States, 54143
        • Bay Area Medical Center
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Saint Luke's Medical Center
      • Oconto Falls, Wisconsin, United States, 54154
        • Saint Vincent Hospital Cancer Center at Oconto Falls
      • Racine, Wisconsin, United States, 53406
        • Aurora Cancer Care-Racine
      • Sheboygan, Wisconsin, United States, 53081
        • HSHS Saint Nicholas Hospital
      • Sturgeon Bay, Wisconsin, United States, 54235
        • Green Bay Oncology - Sturgeon Bay
      • Summit, Wisconsin, United States, 53066
        • Aurora Medical Center in Summit
      • Waukesha, Wisconsin, United States, 53188
        • Aurora Cancer Care-Waukesha
      • Wauwatosa, Wisconsin, United States, 53226
        • Aurora Cancer Care-Milwaukee West
      • West Allis, Wisconsin, United States, 53227
        • Aurora West Allis Medical Center
    • Wyoming
      • Casper, Wyoming, United States, 82609
        • Rocky Mountain Oncology
      • Sheridan, Wyoming, United States, 82801
        • Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Invasive breast cancer, diagnosed by core needle or incisional biopsy (excisional biopsy not permitted)
  • The invasive tumor must be hormone receptor-poor, defined as both estrogen receptor (ER) and progesterone receptor (PgR) negative or staining present in =< 10% of invasive cancer cells by immunohistochemistry (IHC)
  • The invasive tumor must be HER2-negative, defined as IHC 0-1+ or with a fluorescent in situ hybridization (FISH) ratio (HER2 gene copy/chromosome 17) of < 2.0 if IHC 2+
  • Clinical stage II-III invasive breast cancer with intent to perform surgical resection after neoadjuvant therapy; patients with inflammatory breast cancer are not eligible; staging to rule out metastatic disease is recommended for clinical stage III patients
  • Patients with multicentric or bilateral disease are eligible if the target lesion meets eligibility criteria
  • Patient agrees to undergo pretreatment research biopsies
  • No prior chemotherapy, hormone therapy, or radiation therapy with therapeutic intent for this cancer
  • The target lesion in the breast must be >= 1 cm, clinically or radiographically; palpable or radiographically measurable axillary adenopathy will be recorded but will not serve as measurable disease for the primary endpoint; patients with axillary disease only (no identifiable tumor in the breast that is >= 1 cm on physical exam or radiographic study) are not eligible to participate
  • Patients with a history of significant bleeding episodes (e.g., hemoptysis, upper or lower gastrointestinal [GI] bleeding) within 6 months of registration are not eligible
  • No serious or non-healing wound, skin ulcers or bone fracture; no abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within the past 6 months; no major surgical procedure within 28 days prior to randomization or anticipation of need for major surgery during the course of study
  • The following are not considered to be major surgical procedures that would be prohibited in the 28 days prior to, or following study randomization: obtaining the required research needle biopsies; placement of a radiopaque clip to localize a tumor or tumors for subsequent surgical resection; placement of a port for central venous access; fine needle aspiration of a prominent or suspicious axillary lymph node; needle biopsy of a clinically or radiographically detected lesion to rule out metastatic disease; or pretreatment sentinel lymph node sampling
  • No baseline neuropathy grade >= 2
  • Zubrod performance status 0-1
  • Pregnant or nursing women are not eligible; all women of reproductive potential must have a negative pregnancy test at baseline and agree to use an effective, non-hormonal method of contraception during the entire period of treatment on the study
  • Patients with congestive heart failure are not eligible, nor are patients with myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke or transient ischemia attack (TIA) within the past 12 months, uncontrolled hypertension (systolic blood pressure [SBP] > 160 or diastolic blood pressure [DBP] > 90), uncontrolled or symptomatic arrhythmia, or grade II or greater peripheral vascular disease
  • Patients must have a pretreatment multi gated acquisition (MUGA) scan or echocardiogram with a left ventricular ejection fraction (LVEF) above the institutional lower limit of normal
  • Granulocytes > 1,000/mcl
  • Platelets > 100,000/mcl
  • Total bilirubin =< 1.5 x upper limits of normal
  • Calculated or measured > 30 ml/min

  • Urine protein =< 1+ or urine protein to creatinine (UPC) ratio < 1

    • Patients discovered to have >= 2+ proteinuria at baseline must undergo a 24-hour urine collection that must demonstrate < 1 g of protein/24 hr, or UPC ratio < 1 to allow participation in the study
  • Serum alanine aminotransferase (ALT) =< 2.5 x upper limits of normal
  • Serum beta human chorionic gonadotropin (HCG) negative (for women of child bearing potential)

  • Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 x upper limit of normal (ULN)

    • Unless patient is on therapeutic doses of warfarin; if so, the patient must have an INR =< 3 on a stable dose of warfarin, must have not active bleeding or pathologic condition that is associated with a high risk of bleeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (paclitaxel, doxorubicin, cyclophosphamide)
Patients receive paclitaxel IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19.
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Drug: Cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • CTX
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • Cyclophosphamide Monohydrate
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719
  • Asta B 518
  • B-518
  • WR-138719
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • Adriamycin
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex
Experimental: Arm II (paclitaxel, ddAC, bevacizumab)
Patients receive paclitaxel and ddAC as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Drug: Cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • CTX
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • Cyclophosphamide Monohydrate
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719
  • Asta B 518
  • B-518
  • WR-138719
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • Adriamycin
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex
Biological: Bevacizumab
Given IV
Other Names:
  • Avastin
  • ABP 215
  • Anti-VEGF
  • Anti-VEGF Humanized Monoclonal Antibody
  • Anti-VEGF Monoclonal Antibody SIBP04
  • Anti-VEGF rhuMAb
  • Bevacizumab awwb
  • Bevacizumab Biosimilar ABP 215
  • Bevacizumab Biosimilar BEVZ92
  • Bevacizumab Biosimilar BI 695502
  • Bevacizumab Biosimilar CBT 124
  • Bevacizumab Biosimilar CT-P16
  • Bevacizumab Biosimilar FKB238
  • Bevacizumab Biosimilar GB-222
  • Bevacizumab Biosimilar HD204
  • Bevacizumab Biosimilar HLX04
  • Bevacizumab Biosimilar IBI305
  • Bevacizumab Biosimilar LY01008
  • Bevacizumab Biosimilar MIL60
  • Bevacizumab Biosimilar Mvasi
  • Bevacizumab Biosimilar MYL-1402O
  • Bevacizumab Biosimilar QL 1101
  • Bevacizumab Biosimilar RPH-001
  • Bevacizumab Biosimilar SCT501
  • Bevacizumab Biosimilar Zirabev
  • Bevacizumab-awwb
  • Bevacizumab-bvzr
  • BP102
  • BP102 Biosimilar
  • HD204
  • Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer
  • Mvasi
  • MYL-1402O
  • Recombinant Humanized Anti-VEGF Monoclonal Antibody
  • rhuMab-VEGF
  • SCT501
  • SIBP 04
  • SIBP-04
  • SIBP04
  • Zirabev
  • QL1101
  • Bevacizumab Biosimilar QL1101
  • BAT1706
  • BAT 1706
  • BAT-1706
  • BAT1706 Biosimilar
  • Bevacizumab Biosimilar BAT1706
  • Bevacizumab-adcd
  • CT-P16
  • Vegzelma
Experimental: Arm III (paclitaxel, ddAC, carboplatin)
Patients receive paclitaxel and ddAC as in Arm I. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
  • JM8
Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Drug: Cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • CTX
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • Cyclophosphamide Monohydrate
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719
  • Asta B 518
  • B-518
  • WR-138719
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • Adriamycin
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex
Experimental: Arm IV (paclitaxel, ddAC, bevacizumab, carboplatin)
Patients receive paclitaxel and ddAC as in Arm I, bevacizumab as in Arm II, and carboplatin as in Arm III.
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
  • JM8
Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Drug: Cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • CTX
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • Cyclophosphamide Monohydrate
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719
  • Asta B 518
  • B-518
  • WR-138719
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • Adriamycin
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex
Biological: Bevacizumab
Given IV
Other Names:
  • Avastin
  • ABP 215
  • Anti-VEGF
  • Anti-VEGF Humanized Monoclonal Antibody
  • Anti-VEGF Monoclonal Antibody SIBP04
  • Anti-VEGF rhuMAb
  • Bevacizumab awwb
  • Bevacizumab Biosimilar ABP 215
  • Bevacizumab Biosimilar BEVZ92
  • Bevacizumab Biosimilar BI 695502
  • Bevacizumab Biosimilar CBT 124
  • Bevacizumab Biosimilar CT-P16
  • Bevacizumab Biosimilar FKB238
  • Bevacizumab Biosimilar GB-222
  • Bevacizumab Biosimilar HD204
  • Bevacizumab Biosimilar HLX04
  • Bevacizumab Biosimilar IBI305
  • Bevacizumab Biosimilar LY01008
  • Bevacizumab Biosimilar MIL60
  • Bevacizumab Biosimilar Mvasi
  • Bevacizumab Biosimilar MYL-1402O
  • Bevacizumab Biosimilar QL 1101
  • Bevacizumab Biosimilar RPH-001
  • Bevacizumab Biosimilar SCT501
  • Bevacizumab Biosimilar Zirabev
  • Bevacizumab-awwb
  • Bevacizumab-bvzr
  • BP102
  • BP102 Biosimilar
  • HD204
  • Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer
  • Mvasi
  • MYL-1402O
  • Recombinant Humanized Anti-VEGF Monoclonal Antibody
  • rhuMab-VEGF
  • SCT501
  • SIBP 04
  • SIBP-04
  • SIBP04
  • Zirabev
  • QL1101
  • Bevacizumab Biosimilar QL1101
  • BAT1706
  • BAT 1706
  • BAT-1706
  • BAT1706 Biosimilar
  • Bevacizumab Biosimilar BAT1706
  • Bevacizumab-adcd
  • CT-P16
  • Vegzelma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).
Time Frame: At the time of definitive surgical removal, up to 28 weeks
Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain carboplatin (arms 3&4) versus not (arms 1&2) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.
At the time of definitive surgical removal, up to 28 weeks
Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).
Time Frame: At the time of definitive surgical removal, up to 28 weeks
Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain bevacizumab (arms 2&4) versus not (arms 1&3) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.
At the time of definitive surgical removal, up to 28 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).
Time Frame: At the time of definitive surgical removal, up to 28 weeks
Comparing regimens that contain carboplatin (arms 3&4) versus not (arms 1&2).
At the time of definitive surgical removal, up to 28 weeks
Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).
Time Frame: At the time of definitive surgical removal, up to 28 weeks
Comparing regimens that contain bevacizumab (arms 2&4) versus not (arms 1&3).
At the time of definitive surgical removal, up to 28 weeks
Pathologic Stage in the Breast and in the Breast Plus Axilla as Measured by American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM) Staging Criteria (Version 6)
Time Frame: at definitive surgery, up to 28 weeks
Stage II is (T2,T3, N0, M0) tumor size more than 2 cm but no deep extradermal structure invasion, no regional lymph node metastasis, and no distant metastasis. Stage III is (T4, N0, M0) tumor invasion of deep extradermal structures, no regional lymph node metasis, and no distant metasasis or (Any T, N1, M0) Any tumor size, regional lymph node metastasis, and no distant metastasis.
at definitive surgery, up to 28 weeks
Radiographic Response Assessed by Tumor Measurement
Time Frame: Baseline; at completion of neoadjuvant therapy
Assessed by RECIST, each patient will have a pre-therapy baseline radiographic tumor measurement, preferably by MRI, however if logistic or practical or financial issues preclude MRI use, mammogram or ultrasound may be substituted. The longest diameter (LD) of the target lesion at the time of study initiation will be reported as the baseline LD. The baseline LD of the target lesion will be used as reference to further characterize the objective tumor response of the measurable dimension of the disease. Radiographic complete response: Disappearance of the target lesion. Radiographic partial response (PR): At least a 30% decrease in the longest diameter (LD) of the target lesion taking as reference the baseline LD.
Baseline; at completion of neoadjuvant therapy
Clinical Response Assessed by Tumor Measurement
Time Frame: Baseline; at completion of neoadjuvant therapy
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST). Both target and, in the event of multifocal or multicentric invasive breast cancer, nontarget lesions should be followed clinically and their clinical size recorded at aseline. Measurements thereafter are required at the completion of 12 weeks of paclitaxel or paclitaxel/carboplatin and at the completion of all neoadjuvant chemotherapy. At any time point, these lesions should be categorized regarding whether there is evidence of progression. If "yes", the study chair should be notified in order to determine whether the patient should come off protocol treatment. In-situcarcinoma does not represent a non-target lesion and should not be recorded or followed.
Baseline; at completion of neoadjuvant therapy
Overall Survival
Time Frame: up to 10 years
Number of Participants who Died Due to Any Cause
up to 10 years
Recurrence-free Survival
Time Frame: up to 10 years
From definitive surgery to first instance of ipsilateral invasive breast tumor recurrence, local/regional invasive breast cancer recurrence, distant recurrence, or death from any cause. Number of Participants who Died Due to Any Cause or had a recurrence.
up to 10 years
Count of Participants With a First Failure, Defined as First Instance of Ipsilateral Invasive Breast Tumor Recurrence, Local/Regional Invasive Breast Cancer Recurrence, Distant Recurrence, or Death From Any Cause
Time Frame: up to 10 years
From study entry to first event.
up to 10 years
Incidence and Severity of Post-op Complications, Namely Excessive Bleeding, Delayed Wound Healing, and Wound Dehiscence.
Time Frame: at definitive surgery, up to 28 weeks
Assessed by physician observation.
at definitive surgery, up to 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: William M Sikov, Alliance for Clinical Trials in Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2009

Primary Completion (Actual)

August 1, 2014

Study Completion (Estimated)

February 22, 2025

Study Registration Dates

First Submitted

March 12, 2009

First Submitted That Met QC Criteria

March 12, 2009

First Posted (Estimated)

March 13, 2009

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2009-01172 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180821 (U.S. NIH Grant/Contract)
  • U10CA031946 (U.S. NIH Grant/Contract)
  • CALGB 40603/CTSU 40603
  • CALGB-40603 (Other Identifier: CTEP)
  • CDR0000636850
  • CALGB 40603 (Other Identifier: Alliance for Clinical Trials in Oncology)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Study Data/Documents

  1. Individual Participant Data Set

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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