AzTrials
AzTrials

Breast CancerPhase 3NCT01547741

Docetaxel and Cyclophosphamide Compared to Anthracycline-Based Chemotherapy in Treating Women With HER2-Negative Breast Cancer

A Phase 3 study testing Doxorubicin, Cyclophosphamide and Docetaxel in people with Breast Cancer, run by NSABP Foundation Inc at 915 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of breast cancer cells, either by killing the cells or by stopping them from dividing. Giving the drugs in different combinations may kill more breast cancer cells. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Doxorubicin, Cyclophosphamide and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,242 participants
Where
915 sitesin 2 countries
Study dates
Apr 2012to 17 Oct 2025
Phase
Phase 3

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

  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
  • The breast cancer must be Human Epidermal Growth Factor Receptor 2 (HER2)-negative based on current American Society of Clinical Oncology (ASCO)/CAP Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer. If the result of the in situ hybridization testing (FISH, chromagen in situ hybridization [CISH], or other) is equivocal, the patient is eligible if there is no plan to administer HER2-targeted therapy.
  • All of the following staging criteria must be met according to American Joint Committee on Cancer (AJCC) criteria:
  • By pathologic evaluation, primary tumor must be pT1-3;
  • By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b.
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  • If pN0, at least one of the following criteria must be met:
  • ER negative and PgR negative; or
  • Pathologic tumor size greater than 2.0 cm; or
  • T1c (pathologic tumor size greater than 1.0 cm but less than or equal to 2.0 cm) and ER positive (PgR status may be positive or negative) and either grade 3 histology or Oncotype DX® Recurrence Score of greater than or equal to 25.
  • Patients must have undergone either a total mastectomy or breast-conserving surgery (lumpectomy).
  • For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures must be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection.)
  • For patients who undergo mastectomy, margins must be histologically free of invasive tumor and DCIS.
  • Patients must have completed one of the following procedures for evaluation of pathologic nodal status:
  • Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel lymphadenectomy is pN0, pN1mi, or pN1b;
  • Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel lymphadenectomy is pN1a limited to 1 or 2 positive nodes and primary tumor is T1 or T2 by pathologic evaluation;
  • Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive; or
  • Axillary lymphadenectomy with or without SN isolation procedure.
  • The interval between the last surgery for breast cancer (treatment or staging) and randomization must be no more than 84 days.
  • Patients must have ER analysis performed on the primary tumor prior to randomization. Breast cancer must be assessed for ER status by current ASCO/CAP Guideline Recommendations for hormone receptor testing. If negative for ER, assessment of PgR must also be performed according to current ASCO/CAP Guideline Recommendations for hormone receptor testing. (Either a core biopsy or surgical resection specimen can be used for ER/PgR testing.)
  • The most recent postoperative blood counts, performed within 6 weeks prior to randomization, must meet the following criteria:
  • absolute neutrophil count (ANC) must be greater than or equal to 1200/mm3;
  • platelet count must be greater than or equal to 100,000/mm3; and
  • hemoglobin must be greater than or equal to 10 g/dL.
  • The following criteria for evidence of adequate hepatic function must be met based on the results of the most recent postoperative tests performed within 6 weeks prior to randomization:
  • total bilirubin must be less than or equal to upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation greater than ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
  • alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab; and
  • aspartate transaminase (AST) must be less than or equal to 1.5 x ULN for the lab.
  • Alkaline phosphatase and AST may not both be greater than the ULN. For example, if the alkaline phosphatase is greater than the ULN but less than or equal to 2.5 x ULN, then the AST must be less than or equal to the ULN. If the AST is greater than the ULN but less than or equal to 1.5 x ULN, then the alkaline phosphatase must be less than or equal to ULN.
  • Note: If alanine aminotransferase (ALT) is performed instead of AST (per institution's standard practice), the ALT value must be less than or equal to 1.5 x ULN; if both were performed, the AST must be less than or equal to 1.5 x ULN.
  • Patients with AST or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET-CT, or PET scan performed within 90 days prior to randomization) does not demonstrate metastatic disease and the requirements for adequate hepatic function as described above are met.
  • Patients with alkaline phosphatase that is greater than ULN but less than or equal to 2.5 x ULN are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan performed within 90 days prior to randomization does not demonstrate metastatic disease.
  • The most recent postoperative serum creatinine performed within 6 weeks prior to randomization must be less than or equal to ULN for the lab.
  • Left ventricular ejection fraction (LVEF) assessment by 2-D echocardiogram or multigated acquisition (MUGA) scan must be performed within 90 days prior to randomization. The LVEF must be greater than or equal to 50% regardless of the facility's lower limit of normal (LLN). (If the facility performing the assessment has not reported the LVEF as a whole number, decimals reported as greater than or equal to 5 should be rounded up and decimals reported as less than 5 should be rounded down.)

Who cannot join

  • Patients with one or more of the following conditions are ineligible for this study.
  • T4 tumors including inflammatory breast cancer.
  • Definitive clinical or radiologic evidence of metastatic disease. (Chest imaging [mandatory for all patients] and other imaging [if required] must have been performed within 90 days prior to randomization.)
  • Synchronous or previous contralateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS are eligible.)
  • Any history of ipsilateral invasive breast cancer or ipsilateral DCIS.
  • History of non-breast malignancies within 5 years prior to randomization, except for the following: carcinoma in situ of the cervix, colorectal carcinoma in situ, melanoma in situ, and basal cell and squamous cell carcinomas of the skin.
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  • Previous therapy with anthracyclines or taxanes for any malignancy.
  • Chemotherapy administered for the currently diagnosed breast cancer prior to randomization.
  • Continued endocrine therapy such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. Patients are eligible if these medications are discontinued prior to randomization.
  • Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy. Patients are eligible if these medications are discontinued prior to randomization.
  • Known active hepatitis B or hepatitis C with abnormal liver function tests.
  • Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not confined to:
  • Active cardiac disease
  • angina pectoris that requires the use of anti-anginal medication;
  • ventricular arrhythmias except for benign premature ventricular contractions;
  • supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;
  • conduction abnormality requiring a pacemaker;
  • valvular disease with documented compromise in cardiac function;
  • symptomatic pericarditis.
  • History of cardiac disease
  • myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular function;
  • history of documented congestive heart failure (CHF);
  • documented cardiomyopathy.
  • Whole breast radiation therapy (RT) prior to randomization or partial breast RT that cannot be completed on or before the date of randomization.
  • Intrinsic lung disease resulting in dyspnea.
  • Unstable diabetes mellitus.
  • Active infection or chronic infection requiring suppressive antibiotics.
  • History of a major organ allograft or condition requiring chronic immunosuppression, e.g., kidney, liver, lung, heart, bone marrow transplant, or autoimmune diseases. (Patients who have received corneal transplants, cadaver skin, or bone transplants are eligible.)
  • Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) greater than or equal to grade 2, per the NCI CTCAE v4.0.
  • Conditions that would prohibit administration of corticosteroids.
  • Chronic daily treatment with corticosteroids (dose of greater than or equal to 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids).
  • History of hypersensitivity reaction to drugs formulated with polysorbate 80.
  • Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing must be performed within 2 weeks prior to randomization according to institutional standards for women of childbearing potential.)
  • Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
  • Use of any investigational product within 30 days prior to randomization.

Trial locations and contacts

915 sites in 2 countries.

301 sites in 2 countries

United States300 sites

  • Kapiolani Medical Center at Pali Momi

    ‘Aiea, Hawaii, 96701

  • Oncare Hawaii Inc - Kapiolani Medical Center at Pali Momi

    ‘Aiea, Hawaii, 96701

  • Conklin Regional Cancer Center

    Aberdeen, South Dakota, 57401

  • Texas Cancer Center

    Abilene, Texas, 79606

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Bixby Medical Center

    Adrian, Michigan, 49221

  • Hickman Cancer Center

    Adrian, Michigan, 49221

  • Summa Akron City Hospital

    Akron, Ohio, 44304

  • Akron General Medical Center

    Akron, Ohio, 44307

  • New York Oncology Hematology PC - Albany

    Albany, New York, 12206

  • New York Oncology Hematology PC -Albany Medical Center

    Albany, New York, 12208

  • Hematology Oncology Associates

    Albuquerque, New Mexico, 87106

  • University of New Mexico

    Albuquerque, New Mexico, 87106

  • New Mexico Oncology Hematology Consultants

    Albuquerque, New Mexico, 87109

  • Presbyterian Kaseman Hospital

    Albuquerque, New Mexico, 87110

  • Christus Saint Frances Cabrini Hospital

    Alexandria, Louisiana, 71301

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18105

  • Texas Oncology PA - Amarillo

    Amarillo, Texas, 79106

  • American Fork Hospital

    American Fork, Utah, 84003

  • McFarland Clinic

    Ames, Iowa, 50010

  • New York Oncology Hematology PC - Amsterdam

    Amsterdam, New York, 12010

  • Cancer Care Center at Island Hospital

    Anacortes, Washington, 98221

  • Kaiser Anaheim Medical Center

    Anaheim, California, 92807

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • AnMed Health Hospital

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Michigan Cancer Research Consortium Community Clinical Oncology Program

    Ann Arbor, Michigan, 48106

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531

  • Fox Valley Hematology and Oncology

    Appleton, Wisconsin, 54911-3496

  • Texas Oncology-Arlington South

    Arlington, Texas, 76014

  • Randolph Hospital

    Asheboro, North Carolina, 27203

  • Mission Hospitals

    Asheville, North Carolina, 28801

  • Hope Women's Cancer Centers-Asheville

    Asheville, North Carolina, 28816

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Auburn Regional Medical Center

    Auburn, Washington, 98002

  • Augusta Oncology Associates PC-Saint Sebastian

    Augusta, Georgia, 30901

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Kaiser Permanente Medical Group - Baldwin Park

    Baldwin Park, California, 91706

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • The Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Kaiser Permanente-Woodlawn Medical Center

    Baltimore, Maryland, 21244

  • Johns Hopkins University

    Baltimore, Maryland, 21287-8936

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Summa Barberton Hospital

    Barberton, Ohio, 44203

  • Hematology/Oncology Clinic LLP

    Baton Rouge, Louisiana, 70809

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Ochsner Clinic Foundation-Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Bay Regional Medical Center

    Bay City, Michigan, 48708

  • Cleveland Clinic Cancer Center Beachwood

    Beachwood, Ohio, 44122

  • Beaufort Memorial Hospital

    Beaufort, South Carolina, 29902

  • Texas Oncology PA Beaumont

    Beaumont, Texas, 77702

  • Texas Oncology PA - Bedford

    Bedford, Texas, 76022

  • Saint Francis Hospital and Health Centers

    Beech Grove, Indiana, 46107

  • Overlake Hospital Medical Center

    Bellevue, Washington, 98004

  • Kaiser Foundation Hospital

    Bellflower, California, 90706

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Sanford Clinic North-Bemidgi

    Bemidji, Minnesota, 56601

  • Mountainview Medical

    Berlin Corners, Vermont, 05602

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • Constantinou, Costas L MD (UIA Investigator)

    Bettendorf, Iowa, 52722

  • Hematology Oncology Associates-Quad Cities

    Bettendorf, Iowa, 52722

  • Beverly Hospital

    Beverly, Massachusetts, 01915

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • Montana Cancer Consortium CCOP

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies PC

    Billings, Montana, 59102

  • Billings Clinic

    Billings, Montana, 59107-7000

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic

    Bismarck, North Dakota, 58501

  • Saint Alexius Medical Center

    Bismarck, North Dakota, 58501

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61701

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Saint Luke's Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Central Care Cancer Center-Carrie J Babb Cancer Center

    Bolivar, Missouri, 65613

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Toledo Clinic Cancer Centers-Bowling Green

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • CoxHealth Cancer Center

    Branson, Missouri, 65616

  • Harrison Bremerton Hematology and Oncology

    Bremerton, Washington, 98310

  • Harrison Medical Center

    Bremerton, Washington, 98310

  • Blue Ridge Medical Specialists PC

    Bristol, Tennessee, 37620

  • Wellmont Bristol Regional Medical Center

    Bristol, Tennessee, 37620

  • Kings County Hospital

    Brooklyn, New York, 11203

  • State University of New York Downstate Medical Center

    Brooklyn, New York, 11203

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Saint Joseph Regional Cancer Center

    Bryan, Texas, 77802

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence Saint Joseph Medical Center

    Burbank, California, 91505

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

  • Kaiser Permanente-Burke Medical Center

    Burke, Virginia, 22015

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • Alamance Regional Medical Center

    Burlington, North Carolina, 27216

  • University of Vermont

    Burlington, Vermont, 05401

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Graham Hospital Association

    Canton, Illinois, 61520

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Mercy Medical Center

    Canton, Ohio, 44708

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Waverly Hematology Oncology

    Cary, North Carolina, 27518

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants-Castro Valley

    Castro Valley, California, 94546

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Helen G Nassif Community Cancer Center

    Cedar Rapids, Iowa, 52402

  • Saint Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Cedar Rapids Oncology Association

    Cedar Rapids, Iowa, 52403

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Providence Centralia Hospital

    Centralia, Washington, 98531

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Roper Hospital

    Charleston, South Carolina, 29401

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • West Virginia University Charleston

    Charleston, West Virginia, 25304

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Presbyterian Hospital

    Charlotte, North Carolina, 28204

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Erlanger Medical Center

    Chattanooga, Tennessee, 37403

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • Mount Sinai Hospital Medical Center

    Chicago, Illinois, 60608

  • Northwestern University

    Chicago, Illinois, 60611

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612-3785

  • University of Illinois

    Chicago, Illinois, 60612

  • Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Great Lakes Cancer Institute

    Clarkston, Michigan, 48346

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Maryland Oncology Hematology PA-Columbia

    Columbia, Maryland, 21044

  • University of Missouri - Ellis Fischel

    Columbia, Missouri, 65203

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Columbus CCOP

    Columbus, Ohio, 43215

  • 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

  • New Hampshire Oncology-Hematology PA

    Concord, New Hampshire, 03301

  • Carolinas Medical Center - Northeast

    Concord, North Carolina, 28025

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Baptist Regional Medical Center

    Corbin, Kentucky, 40701

  • Ochsner North Shore Medical Center

    Covington, Louisiana, 70433

  • Texas Cancer Center - Medical City Dallas

    Dallas, Texas, 75230

  • Texas Health Presbyterian Hospital Dallas

    Dallas, Texas, 75231

  • Texas Oncology Methodist Charlton Cancer Center

    Dallas, Texas, 75237

  • Texas Oncology PA

    Dallas, Texas, 75246

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Genesis Medical Center - East Campus

    Davenport, Iowa, 52803

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Health Center

    Dayton, Ohio, 45415

  • Dayton CCOP

    Dayton, Ohio, 45420

  • Oakwood Hospital

    Dearborn, Michigan, 48124

  • Dekalb Medical Center

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Texas Oncology-Denton South

    Denton, Texas, 76210

  • Saint Anthony Central Hospital

    Denver, Colorado, 80204

  • Kaiser Permanente-Franklin

    Denver, Colorado, 80205

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Exempla Saint Joseph Hospital

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • Colorado Cancer Research Program CCOP

    Denver, Colorado, 80224-2522

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa Oncology Research Association CCOP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Wayne State University

    Detroit, Michigan, 48202

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Bayhealth Medical Center at Kent General

    Dover, Delaware, 19901

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901

  • Epic Care-Dublin

    Dublin, California, 94568

  • Essentia Health Duluth Clinic CCOP

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Saint Luke's Hospital of Duluth

    Duluth, Minnesota, 55805

  • Hematology Oncology Associates of Central New York PC

    East Syracuse, New York, 13057

  • The Memorial Hospital at Easton

    Easton, Maryland, 21601

  • Marshfield Clinic Cancer Center at Sacred Heart

    Eau Claire, Wisconsin, 54701

  • Midelfort Clinic-Clairemont Campus

    Eau Claire, Wisconsin, 54702

  • Mayo Clinic Health System Eau Claire Hospital - Luther Campus

    Eau Claire, Wisconsin, 54703

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Puget Sound Cancer Center

    Edmonds, Washington, 98026

  • Swedish Medical Center-Edmonds

    Edmonds, Washington, 98026

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Texas Oncology-El Paso

    El Paso, Texas, 79915

  • Elkhart Clinic

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology Oncology PC-Elkhart

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • Community Health Partners Regional Medical Center

    Elyria, Ohio, 44035

  • Hematology Oncology Center Incorporated

    Elyria, Ohio, 44035

  • Newman Regional Health

    Emporia, Kansas, 66801

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

  • The Regional Cancer Center

    Erie, Pennsylvania, 16505

  • Green Bay Oncology - Escanaba

    Escanaba, Michigan, 49431

  • Eureka Hospital

    Eureka, Illinois, 61530

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Evanston CCOP-NorthShore University HealthSystem

    Evanston, Illinois, 60201

  • Saint Francis Hospital

    Evanston, Illinois, 60202

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Virginia Cancer Specialists-Fairfax

    Fairfax, Virginia, 22031

  • Kaiser Permanente - Fair Oaks Medical Center

    Fairfax, Virginia, 22033

  • Northbay Cancer Center

    Fairfield, California, 94533

  • Saint Anne's Hospital

    Fall River, Massachusetts, 02721

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

  • Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Sanford Clinic North-Fargo

    Fargo, North Dakota, 58122

  • Sanford Medical Center-Fargo

    Fargo, North Dakota, 58122

  • University of Connecticut

    Farmington, Connecticut, 06030

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Lake Region Healthcare Corporation-Cancer Care

    Fergus Falls, Minnesota, 56537

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Hurley Medical Center

    Flint, Michigan, 48502

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Genesys Regional Medical Center-West Flint Campus

    Flint, Michigan, 48532

  • McLaren Regional Cancer Center

    Flint, Michigan, 48532

  • Singh and Arora Hematology Oncology PC

    Flint, Michigan, 48532

  • McLeod Regional Medical Center

    Florence, South Carolina, 29506

  • Texas Oncology-Flower Mound

    Flower Mound, Texas, 75028

  • Kaiser Permanente Hospital

    Fontana, California, 92335

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Fort Wayne Medical Oncology and Hematology Inc - State Boulevard

    Fort Wayne, Indiana, 46845

  • Texas Oncology Fort Worth at 12th Avenue

    Fort Worth, Texas, 76104

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Frederick Memorial Hospital

    Frederick, Maryland, 21701

  • Fredericksburg Oncology Inc

    Fredericksburg, Virginia, 22401

  • Hematology Oncology Associates of Fredericksburg Inc

    Fredericksburg, Virginia, 22408

  • FHN Leonard C. Ferguson Cancer Center

    Freeport, Illinois, 61032

  • Kaiser Permanente, Fremont

    Fremont, California, 94538

  • Valley Medical Oncology Consultants-Fremont

    Fremont, California, 94538

  • Washington Hospital

    Fremont, California, 94538

  • California Cancer Center - North Fresno

    Fresno, California, 93720

  • Kaiser Permanente

    Fresno, California, 93720

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Mountain States Tumor Institute - Fruitland

    Fruitland, Idaho, 83619

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Kaiser Permanente-Gaithersburg Medical Center

    Gaithersburg, Maryland, 20879

  • Illinois CancerCare Galesburg

    Galesburg, Illinois, 61401

  • Medical and Surgical Specialists

    Galesburg, Illinois, 61401

  • Texas Oncology - Garland

    Garland, Texas, 75042

  • Gaston Memorial Hospital

    Gastonia, North Carolina, 28054

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Addison Gilbert Hospital

    Gloucester, Massachusetts, 01930

  • Peninsula Cancer Institute-Gloucester

    Gloucester, Virginia, 23061

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439

  • Altru Cancer Center

    Grand Forks, North Dakota, 58201

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Three Rivers Community Hospital

    Grants Pass, Oregon, 97527

  • Saint Rose Ambulatory and Surgery Center

    Great Bend, Kansas, 67530

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

Other trials in United States

Puerto Rico1 site

  • San Juan City Hospital

    San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of breast cancer cells, either by killing the cells or by stopping them from dividing. Giving the drugs in different combinations may kill more breast cancer cells. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating women with non-metastatic breast cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To determine if the docetaxel and cyclophosphamide (TC) regimen is non-inferior to the anthracycline-based chemotherapy regimens in terms of invasive disease-free survival (DFS) by combining B-49 data with the docetaxel, doxorubicin, and cyclophosphamide (TAC) and TC arms of NSABP B-46-I/US Oncology Research, Inc.(USOR) 07132 and the data from USOR 06-090.

Secondary

  • To determine rates of DFS-ductal carcinoma in situ (DCIS) for the TC and anthracycline-based chemotherapy regimens.
  • To determine rates of overall survival (OS) for the TC and anthracycline-based chemotherapy regimens.
  • To determine rates of recurrence-free interval (RFI) for the TC and anthracycline-based chemotherapy regimens.
  • To evaluate the toxicity associated with each of the regimens.
  • To determine the role of TOP2A in prognosis and prediction of degree of benefit from anthracycline-based chemotherapy over TC. (exploratory)
  • To develop predictive markers for benefit from doxorubicin. (exploratory)

OUTLINE: This is a multicenter randomized study. Patients are stratified according to number of positive nodes (0 vs 1-3 vs 4-9 vs 10+) and hormone-receptor status (estrogen receptor [ER] and/or progesterone receptor [PgR] positive vs ER and PgR negative). Patients are randomized to 1 of 2 treatment arms.

Conditions
Breast Cancer
Keywords
estrogen receptor-negative breast cancer, estrogen receptor-positive breast cancer, HER2-negative breast cancer, progesterone receptor-negative breast cancer, progesterone receptor-positive breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIC breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

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

Study groups in NCT01547741
Study groupRoleWhat they receive
Arm 1: Anthracycline-based chemotherapyActive comparator4 anthracycline-based chemotherapy regimens (Regimens A, B, C, or D). Regimen A (TAC): 75 mg/m2 docetaxel (T) + 50 mg/m2 doxorubicin (A) + 500 mg/m2 cyclophosphamide (C) IV every 3 weeks for 6 cycles. Regimen B (AC then WP): 60 mg/m2 doxorubicin (A) + 600 mg/m2 cyclophosphamide (C) every 3 weeks for 4 cycles followed by weekly paclitaxel (WP) 80 mg/m2 IV every week for 12 doses. Regimen C (DD AC then WP): 60 mg/m2 doxorubicin + 600 mg/m2 cyclophosphamide every 2 weeks for 4 cycles followed by weekly paclitaxel 80 mg/m2 IV every week for 12 doses. Regimen D (DD AC then DD P): 60 mg/m2 doxorubicin + 600 mg/m2 cyclophosphamide every 2 weeks for 4 cycles followed by paclitaxel (P) 175 mg/m2 IV every 2 weeks for 4 cycles.
Receives: Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Paclitaxel
Arm 2: docetaxel + cyclophosphamideActive comparatorTC: 75 mg/m2 docetaxel and 600 mg/m2 cyclophosphamide IV every 3 weeks for 6 cycles
Receives: Drug: Cyclophosphamide; Drug: Docetaxel

What is being measured

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

  1. Invasive Disease-free Survival (IDFS)

    The time to local recurrence following mastectomy, invasive local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, invasive contralateral breast cancer, second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause prior to recurrence or second primary cancer.

    Measured: Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly years 6-10.

Secondary outcomes (4)

  1. Disease-free Survival (DFS-DCIS)

    The time to local recurrence following mastectomy, local recurrence in the ipsilateral breast following lumpectomy (invasive or non-invasive), regional recurrence, distant recurrence, contralateral breast cancer (invasive or non-invasive), second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause prior to recurrence or second primary cancer.

    Measured: Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly years 6-10.

  2. Overall Survival (OS)

    Time from randomization until death from any cause.

    Measured: Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly years 6-10.

  3. Recurrence-free Interval (RFI)

    Time from randomization until local, regional, or distant recurrence.

    Measured: Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly years 6-10.

  4. Percentage of Participants With Adverse Events

    Adverse events categorized using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

    Measured: Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly years 6-10.

Timeline

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

  1. First posted8 Mar 2012 (estimated)
  2. Study startApr 2012
  3. Primary completion31 May 2022
  4. Study completion17 Oct 2025

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01547741
Sponsor's protocol ID
NSABP-B-49
Other IDs
NCI-2012-00701
Status last verified
Aug 2026
First submitted
6 Mar 2012
Last updated
6 Aug 2026
Data monitoring committee
Yes

Publications

  • Geyer CE Jr, Blum JL, Yothers G, Asmar L, Flynn PJ, Robert NJ, Hopkins JO, O'Shaughnessy JA, Rastogi P, Puhalla SL, Hilton CJ, Dang CT, Gomez HL, Vukelja SJ, Lyss AP, Paul D, Brufsky AM, Colangelo LH, Swain SM, Mamounas EP, Wolmark N. Long-Term Follow-Up of the Anthracyclines in Early Breast Cancer Trials (USOR 06-090, NSABP B-46-I/USOR 07132, and NSABP B-49 [NRG Oncology]). J Clin Oncol. 2024 Apr 20;42(12):1344-1349. doi: 10.1200/JCO.23.01428. Epub 2024 Feb 9.

    PubMed 38335467

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