AzTrials
AzTrials

Breast CancerPhase 3NCT00087178

Comparison of Two Combination Chemotherapy Regimens in Treating Women With Breast Cancer

A Phase 3 study testing cyclophosphamide, adriamycin and epirubicin in people with Breast Cancer, run by NSABP Foundation Inc at 606 sites in 3 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, such as fluorouracil, epirubicin, cyclophosphamide, and doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective in treating breast cancer. 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?
cyclophosphamide, adriamycin and epirubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,722 participants
Where
606 sitesin 3 countries
Study dates
May 2004to May 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

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

Eligibility

  • Patients must be greater than or equal to 18 years of age.
  • The patient must have a life expectancy of at least 10 years, excluding her diagnosis of breast cancer. (Comorbid conditions and performance status should be taken into consideration, but not the diagnosis of breast cancer.)
  • The interval between the last surgery for breast cancer treatment (lumpectomy, mastectomy, sentinel lymph node biopsy, axillary surgery, or re-excision of lumpectomy margins) and randomization must be no more than 84 days.
  • The tumor must be invasive adenocarcinoma on histologic examination. (Patients with tumors that are pure tubular or mucinous adenocarcinomas are not eligible.)
  • The primary tumor must be T1-3 by clinical and pathologic evaluation.
  • Lymph nodes obtained from all axillary staging procedures must be pN0 according to pathologic staging criteria of the 6th edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual.
  • Patients must have undergone axillary nodal staging procedures, for example sentinel node (SN) biopsy alone, SN biopsy followed by axillary sampling or completion dissection, or axillary node dissection to obtain lymph nodes for pathologic evaluation. If the patient has palpable nodes, axillary dissection is required.
  • Patients must have an estrogen receptor (ER) analysis performed on the primary tumor prior to randomization. If ER is negative, then progesterone receptor (PgR) analysis must be performed. If ER is positive, PgR analysis is desired, but not mandatory. ("Marginal" or "borderline" results [i.e., those not definitively negative] will be considered positive regardless of the methodology used.)
  • Patients must have had either a lumpectomy or total mastectomy.
  • Patients must have no clinical or radiologic evidence of metastatic disease.
  • Patients with skeletal pain are eligible for inclusion in the study if bone scan or roentgenological examination fail to disclose metastatic disease. Suspicious findings must be confirmed as benign by x-ray, MRI, or biopsy.
  • The patient's menopausal status must be determined prior to randomization.
  • Pre- and postmenopausal women are eligible. The following criteria will be used to define postmenopausal:
  • a prior documented bilateral oophorectomy, or
  • a history of at least 12 months without spontaneous menstrual bleeding, or
  • age 55 or older with a prior hysterectomy or
  • age 54 or younger with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown), with a documented follicle-stimulating hormone (FSH) level demonstrating confirmatory elevation in the lab's postmenopausal range.
  • Women failing to meet one of these criteria will be classified as premenopausal.
  • At the time of randomization, the patient must have had the following: history and physical exam, EKG, and PA and lateral chest x-ray or chest CT within the past 3 months; bilateral mammogram within the past 6 months; and pelvic exam (for women who have a uterus and who will be receiving tamoxifen) within the past year.
  • Within 3 months prior to entry, the patient must have a baseline LVEF measured by Multi Gated Acquisition (MUGA) scan or echocardiogram equal to or greater than the lower limit of normal for the facility performing the procedure.
  • At the time of randomization:
  • The postoperative absolute granulocyte count (AGC) must be greater than or equal to 1500/mm3 (or greater than or equal to 1200/mm3 if, in the opinion of the investigator, this represents an ethnic or racial variant of normal).
  • Postoperative platelet count must be greater than or equal to 100,000/mm3. Significant underlying hematologic disorders must be excluded when the platelet count is above the ULN for the lab.
  • There must be postoperative evidence of adequate hepatic function, i.e.,
  • total bilirubin must be less than or equal to ULN for the lab unless the patient has a chronic Grade 1 bilirubin elevation (greater than ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome due to slow conjugation of bilirubin; and
  • alkaline phosphatase must be less than 2.5 x ULN for the lab; and
  • the aspartate transaminase (AST) [serum glutamic-oxaloacetic transaminase (SGOT)] must be less than or equal to 1.5 x ULN for the lab.
  • There must be postoperative evidence of normal renal function (serum creatinine less than or equal to ULN).
  • Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
  • Special conditions for eligibility of lumpectomy patients: radiation therapy and surgery Patients treated by lumpectomy followed by breast radiation therapy must meet all the eligibility criteria in addition to the following:
  • Generally, lumpectomy should be reserved for tumors less than 5 cm. However, at the investigator's discretion, patients treated with lumpectomy for tumors greater than or equal to 5 cm are eligible if eligibility criteria for lumpectomy are met.
  • The margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. In patients in whom pathologic examination demonstrates tumor present at the line of resection, additional operative procedures may be performed to obtain clear margins. This is permissible even if axillary dissection has been performed. Patients in whom tumor is still present at the resected margin after re-excision(s) must undergo total mastectomy to be eligible.
  • This is a node-negative study, therefore irradiation of regional lymph nodes is prohibited in this trial.
  • Whole breast irradiation is required unless the patient is assigned to the partial breast irradiation group on NSABP B-39.
  • Postmastectomy chest wall irradiation at the investigator's discretion is permitted. However, this is a node-negative study; therefore irradiation of regional lymph nodes is prohibited in this trial.

Ineligibility

  • Male patients are not eligible for this study.
  • Pure tubular or mucinous adenocarcinomas.
  • Bilateral malignancy (including DCIS) or a mass or mammographic abnormality in the opposite breast suspicious for malignancy unless there is biopsy proof that the mass is not malignant.
  • Primary tumor staged as T4 for any reason.
  • Suspicious palpable nodes in the ipsilateral or contralateral axilla or palpable supraclavicular or infraclavicular nodes. Patients with these conditions are considered ineligible unless there is biopsy evidence that these are not involved with tumor.
  • Prior history of breast cancer, including DCIS (patients with a history of lobular carcinoma in situ [LCIS] are eligible).
  • Treatment including radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to randomization. The only exceptions are:
  • Hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before study entry. In such a case, hormonal therapy must stop at or before randomization and be re-started, if indicated, following chemotherapy.
  • If patient is enrolled in NSABP B-39 and randomized to Group 2, partial breast irradiation (PBI) may be completed prior to beginning treatment on NSABP B-36.
  • Prior anthracycline therapy for any malignancy.
  • Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc.. (These patients are eligible if this therapy is discontinued prior to randomization.)
  • Therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention. (Patients are eligible only if these medications are discontinued prior to randomization. With the exception of tamoxifen, these medications are not permitted while on the study.)
  • Cardiac disease that would preclude the use of anthracyclines. This includes:
  • any documented myocardial infarction;
  • angina pectoris that requires the use of anti-anginal medication;
  • any history of documented congestive heart failure;
  • serious cardiac arrhythmia requiring medication,
  • severe conduction abnormality;
  • valvular disease with documented cardiac function compromise; and
  • poorly controlled hypertension, i.e., diastolic greater than 100 mm/Hg. (Patients with hypertension that is well controlled on medication are eligible for entry.)
  • Non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude a patient from being subjected to any of the treatment options or would prevent prolonged follow-up.
  • Pregnancy or lactation at the time of proposed randomization. Women of reproductive potential must agree to use an effective non-hormonal method of contraception.
  • Concurrent treatment with investigational agents.
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
  • Special conditions for ineligibility of lumpectomy patients: radiation therapy and surgery. For patients treated by lumpectomy, breast irradiation is required. The following patients will be ineligible:
  • Patients with diffuse tumors (as demonstrated on mammography) that would not be considered surgically amenable to lumpectomy. (These patients are eligible if they undergo mastectomy.)
  • Patients treated with lumpectomy in whom there is another clinically dominant mass or mammographically suspicious abnormality within the ipsilateral breast remnant. Such a mass must be biopsied and demonstrated to be histologically benign prior to randomization or, if malignant, must be surgically removed with clear margins.
  • Patients in whom the margins of the resected specimen are involved with invasive tumor or ductal carcinoma in situ (DCIS). Additional surgical resections to obtain free margins are allowed. Patients in whom tumor is still present after the additional resection(s) must undergo mastectomy to be eligible. (Patients with margins positive for LCIS are eligible without additional resection.)

Trial locations and contacts

606 sites in 3 countries.

320 sites in 3 countries

United States300 sites

  • Oncology Services of Aberdeen

    Aberdeen, South Dakota, 57401

  • Rosenfeld Cancer Center at Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • New York Oncology Hematology, PC at Albany Regional Cancer Care

    Albany, New York, 12206

  • New York Oncology Hematology, PC at Albany Medical Center

    Albany, New York, 12208

  • Hematology Oncology Associates, PC

    Albuquerque, New Mexico, 87106

  • Lovelace Medical Center - Gibson

    Albuquerque, New Mexico, 87108

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131-5636

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, 62002

  • American Fork Hospital

    American Fork, Utah, 84003

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Amsterdam Community Cancer Program

    Amsterdam, New York, 12010

  • Providence Cancer Center

    Anchorage, Alaska, 99508

  • AnMed Cancer Center

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Randolph Hospital

    Asheboro, North Carolina, 27203-5400

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Cancer Resource Center at King's Daughters Medical Center

    Ashland, Kentucky, 41101-0151

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Northside Hospital Cancer Center

    Atlanta, Georgia, 30342-1611

  • Saint Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342-1701

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342

  • Augusta Oncology Associates - Walton Way

    Augusta, Georgia, 30901

  • MBCCOP - Medical College of Georgia Cancer Center

    Augusta, Georgia, 30912

  • Aurora Presbyterian Hospital

    Aurora, Colorado, 80012

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60504

  • WellStar Cobb Hospital

    Austell, Georgia, 30106

  • Texas Oncology - Midtown Austin

    Austin, Texas, 78705

  • Texas Oncology, PA at Texas Oncology Cancer Center - Central

    Austin, Texas, 78731

  • Texas Oncology, PA at South Austin Cancer Center

    Austin, Texas, 78745

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Greater Baltimore Medical Center Cancer Center

    Baltimore, Maryland, 21204

  • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

    Baltimore, Maryland, 21215

  • Harbor View Cancer Center at Harbor Hospital

    Baltimore, Maryland, 21225

  • St. Agnes Hospital Cancer Center

    Baltimore, Maryland, 21229

  • Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Pennington Cancer Center at Baton Rouge General

    Baton Rouge, Louisiana, 70806

  • Ochsner Health Center - Bluebonnet

    Baton Rouge, Louisiana, 70809

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • Bay Regional Medical Center

    Bay City, Michigan, 48708

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • Mary Rutan Hospital

    Bellefontaine, Ohio, 43311

  • Overlake Cancer Center at Overlake Hospital Medical Center

    Bellevue, Washington, 98004

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • MeritCare Bemidji

    Bemidji, Minnesota, 56601

  • Green Mountain Oncology Group

    Bennington, Vermont, 05201

  • Alta Bates Summit Comprehensive Cancer Center

    Berkeley, California, 94704

  • Suburban Hospital

    Bethesda, Maryland, 20814

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center Cancer Center

    Bismarck, North Dakota, 58502

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Tufts-NEMC Cancer Center

    Boston, Massachusetts, 02111

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Boulder Community Hospital

    Boulder, Colorado, 80301-9019

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • St. Joseph Regional Cancer Center

    Bryan, Texas, 77802

  • Peninsula Medical Center

    Burlingame, California, 94010

  • Alamance Cancer Center at Alamance Regional Medical Center

    Burlington, North Carolina, 27216

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Graham Hospital

    Canton, Illinois, 61520

  • Aultman Cancer Center at Aultman Hospital

    Canton, Ohio, 44710-1799

  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

    Cape Girardeau, Missouri, 63701

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital

    Carthage, Illinois, 62321

  • 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

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • John H. Stroger, Jr. Hospital of Cook County

    Chicago, Illinois, 60612-3785

  • Creticos Cancer Center at Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Christ Hospital Cancer Center

    Cincinnati, Ohio, 45219

  • Oncology Hematology Care, Incorporated - Blue Ash

    Cincinnati, Ohio, 45242

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • Finger Lakes Hematology and Oncology

    Clifton Springs, New York, 14432

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210-1240

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Medical Center Cancer Care

    Columbus, Ohio, 43215

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Commonwealth Hematology-Oncology, PC - Concord

    Concord, Massachusetts, 01742

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Hematology and Oncology Associates of Rhode Island

    Cranston, Rhode Island, 02920

  • Genesis Regional Cancer Center at Genesis Medical Center

    Davenport, Iowa, 52803

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • Herbert D. Kerman Regional Oncology Center - Daytona Beach

    Daytona Beach, Florida, 32115

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Charles B. Eberhart Cancer Center at DeKalb Medical Center

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • St. Anthony Central Hospital

    Denver, Colorado, 80204

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • St. Joseph Hospital

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • CCOP - Colorado Cancer Research Program

    Denver, Colorado, 80224-2522

  • Mercy Capitol Hospital

    Des Moines, Iowa, 50307

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa, 50314

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Commonwealth Hematology Oncology PC - Dorchester

    Dorchester, Massachusetts, 02124

  • Kent General Hospital

    Dover, Delaware, 19901

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center

    DuBois, Pennsylvania, 15801

  • St. Luke's Hospital Cancer Care Center

    Duluth, Minnesota, 55805

  • Dale and Frances Hughes Cancer Center at Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Easton Regional Cancer Center at Easton Hospital

    Easton, Pennsylvania, 18042

  • Center for Cancer Treatment & Prevention at Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Marshfield Clinic Cancer Care at Regional Cancer Center

    Eau Claire, Wisconsin, 54701

  • John Smith, Jr. - Dalton McMichael Cancer Center at Morehead Memorial Hospital

    Eden, North Carolina, 27288

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Sherman Hospital

    Elgin, Illinois, 60120

  • Alexian Brothers Radiation Oncology

    Elk Grove Village, Illinois, 60007

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn

    Elkhorn, Wisconsin, 53121

  • Union Hospital Cancer Program at Union Hospital

    Elkton, Maryland, 21921

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • Ephrata Cancer Center at Ephrata Community Hospital

    Ephrata, Pennsylvania, 17522

  • Regional Cancer Center - Erie

    Erie, Pennsylvania, 16505

  • Saint Vincent Health Center

    Erie, Pennsylvania, 16544

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • Evanston Northwestern Healthcare - Evanston Hospital

    Evanston, Illinois, 60201-1781

  • Center for Cancer Care at Exeter Hospital

    Exeter, New Hampshire, 03833

  • Kaiser Permanente Medical Center - Fair Oaks

    Fairfax, Virginia, 22033

  • North Bay Cancer Center

    Fairfield, California, 94533

  • Hudner Oncology Center at Saint Anne's Hospital - Fall River

    Fall River, Massachusetts, 02721

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • MeritCare Broadway

    Fargo, North Dakota, 58122

  • Cape Fear Valley Medical Center Cancer Center

    Fayetteville, North Carolina, 28302-2000

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Study site

    Fergus Falls, Minnesota, 56537

  • Hunterdon Regional Cancer Center at Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Great Lakes Cancer Institute at McLaren Regional Medical Center

    Flint, Michigan, 48532

  • Central Wisconsin Cancer Program at Agnesian HealthCare

    Fond du Lac, Wisconsin, 54935

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

  • Dwight David Eisenhower Army Medical Center

    Fort Gordon, Georgia, 30905-5650

  • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Broward General Medical Center Cancer Center

    Fort Lauderdale, Florida, 33316

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46815

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Kaiser Permanente - Fremont

    Fremont, California, 94538

  • Valley Medical Oncology

    Fremont, California, 94538

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Galesburg Clinic, PC

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • CaroMont Cancer Center at Gaston Memorial Hospital

    Gastonia, North Carolina, 28053

  • Delnor Community Hospital - Geneva

    Geneva, Illinois, 60134

  • Banner Thunderbird Medical Center

    Glendale, Arizona, 85306

  • Glendale Memorial Hospital Comprehensive Cancer Center

    Glendale, California, 91204

  • Oncology Alliance, SC - Milwaukee - East

    Glendale, Wisconsin, 53212-1038

  • Charles R. Wood Cancer Center at Glens Falls Hospital

    Glens Falls, New York, 12801

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81502

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Metro Health Hospital

    Grand Rapids, Michigan, 49506

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54301-3526

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • California Cancer Care, Incorporated - Greenbrae

    Greenbrae, California, 94904

  • Marin Cancer Institute at Marin General Hospital

    Greenbrae, California, 94904

  • Sutter Health - Western Division Cancer Research Group

    Greenbrae, California, 94904

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27403-1198

  • Leo W. Jenkins Cancer Center at ECU Medical School

    Greenville, North Carolina, 27835-6028

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Cancer Institute of New Jersey at Hamilton

    Hamilton, New Jersey, 08690

  • Virginia Oncology Associates - Hampton

    Hampton, Virginia, 23666

  • PinnacleHealth Regional Cancer Center at Polyclinic Hospital

    Harrisburg, Pennsylvania, 17110-2098

  • Helen and Harry Gray Cancer Center at Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • Hattiesburg Clinic, PA at Forrest General

    Hattiesburg, Mississippi, 39401

  • Hematology & Oncology Clinic

    Hattiesburg, Mississippi, 39402

  • Mason District Hospital

    Havana, Illinois, 62644

  • Commonwealth Hematology-Oncology, PC - Haverhill

    Haverhill, Massachusetts, 01830

  • Kaiser Permanente Medical Center - Hayward

    Hayward, California, 94545

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Hinsdale Hematology Oncology Associates

    Hinsdale, Illinois, 60521

  • Holland Community Hospital

    Holland, Michigan, 49423

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Queen's Cancer Institute at Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital, Incorporated

    Honolulu, Hawaii, 96813

  • Hawaii Medical Center - East

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Hopedale Medical Complex

    Hopedale, Illinois, 61747

  • Terrebonne General Medical Center

    Houma, Louisiana, 70360

  • Baylor University Medical Center - Houston

    Houston, Texas, 77030

  • New York Oncology Hematology, PC - Hudson

    Hudson, New York, 12534

  • Edwards Comprehensive Cancer Center at Cabell Huntington Hospital

    Huntington, West Virginia, 25701

  • St. Mary's Regional Cancer Center at St. Mary's Medical Center

    Huntington, West Virginia, 25702

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Independence Regional Health Center

    Independence, Missouri, 64050

  • Methodist Cancer Center at Methodist Hospital

    Indianapolis, Indiana, 46202

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • Queens Cancer Center of Queens Hospital

    Jamaica, New York, 11432

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Freeman Cancer Institute at Freeman Health System

    Joplin, Missouri, 64804

  • St. John's Regional Medical Center

    Joplin, Missouri, 64804

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Provena St. Mary's Regional Cancer Center - Kankakee

    Kankakee, Illinois, 60901

  • Providence Medical Center

    Kansas City, Kansas, 66112

  • Truman Medical Center - Hospital Hill

    Kansas City, Missouri, 64108

  • Saint Luke's Cancer Institute at Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • Kansas City Cancer Center at St. Joseph's Medical Mall

    Kansas City, Missouri, 64114

  • St. Joseph Medical Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Parvin Radiation Oncology

    Kansas City, Missouri, 64116

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center

    Kansas City, Missouri, 64154

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Richard G. Laube Cancer Center at ACMH

    Kittanning, Pennsylvania, 16201

  • U.T. Medical Center Cancer Institute

    Knoxville, Tennessee, 37920-6999

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • La Grange Memorial Hospital

    La Grange, Illinois, 60525

  • Scripps Cancer Center - San Diego

    La Jolla, California, 92037

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Clarian Arnett Cancer Care

    Lafayette, Indiana, 47904

  • Center for Cancer Care and Research at Watson Clinic, LLP

    Lakeland, Florida, 33805

  • Lakeland Regional Cancer Center at Lakeland Regional Medical Center

    Lakeland, Florida, 33805

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Breslin Cancer Center at Ingham Regional Medical Center

    Lansing, Michigan, 48910

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • Lapeer Regional Hospital

    Lapeer, Michigan, 48446

  • Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility

    Largo, Maryland, 20774

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • New York Oncology Hematology, PC - Latham

    Latham, New York, 12110

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Commonwealth Hematology-Oncology, PC - Lawrence

    Lawrence, Massachusetts, 01842

  • Gwinnett Medical Center

    Lawrenceville, Georgia, 30045

  • Cleo Craig Cancer Research Clinic

    Lawton, Oklahoma, 73505

  • Commonwealth Hematology Oncology PC - Leominster

    Leominster, Massachusetts, 01453

  • St. Mary's Hospital

    Leonardtown, Maryland, 20650

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Cancer Resource Center - Lincoln

    Lincoln, Nebraska, 68510

  • Meeker County Memorial Hospital

    Litchfield, Minnesota, 55355

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Loma Linda University Cancer Institute at Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Pacific Shores Medical Group - Long Beach

    Long Beach, California, 90813

Other trials in United States

Canada16 sites

  • Tom Baker Cancer Centre - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute at University of Alberta

    Edmonton, Alberta, T6G 1Z2

  • Trillium Health Centre - Mississauga Site

    Mississauga, Ontario, L5B 1B8

  • Carlo Fidani Peel Regional Cancer Centre at Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • Hopital Notre-Dame du CHUM

    Montreal, Quebec, H2L 4M1

  • CHUM - Hotel Dieu Hospital

    Montreal, Quebec, H2W 1T8

  • CHUM - Hopital Saint-Luc

    Montreal, Quebec, H2X 3J4

  • Royal Victoria Hospital - Montreal

    Montreal, Quebec, H3A 1A1

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Jewish General Hospital - Montreal

    Montreal, Quebec, H3T 1E2

  • Ottawa Hospital Regional Cancer Centre - General Campus

    Ottawa, Ontario, K1Y 4K7

  • Hopital du Saint-Sacrement - Quebec

    Québec, Quebec, G1S 4L8

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Edmond Odette Cancer Centre at Sunnybrook

    Toronto, Ontario, M4N 3M5

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Puerto Rico4 sites

  • Andres Grillasca Hospital

    Ponce, 00733

  • Hato Rey Hematology/Oncology Group, PSC

    San Juan, 00917

  • I. Gonzalez Martinez Oncologic Hospital

    San Juan, 00919

  • San Juan City Hospital

    San Juan, 00928

Other trials in Puerto Rico

About this study

Official title: A Clinical Trial Of Adjuvant Therapy Comparing Six Cycles Of 5-Fluorouracil, Epirubicin And Cyclophosphamide (FEC) To Four Cycles Of Adriamycin And Cyclophosphamide (AC) In Patients With Node-Negative Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, epirubicin, cyclophosphamide, and doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective in treating breast cancer.

PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens to compare how well they work in treating women who have undergone surgery for breast cancer that has not spread to the lymph nodes.

Read the detailed description

OBJECTIVES:

Primary

  • Compare disease-free survival of women with node-negative breast cancer treated with adjuvant fluorouracil, epirubicin, and cyclophosphamide vs doxorubicin and cyclophosphamide.

Secondary

  • Compare survival, recurrence-free interval, and distant recurrence-free interval in patients treated with these regimens.
  • Compare adverse events in patients treated with these regimens.
  • Compare quality of life, with regard to physical functioning, vitality, symptoms, and rates of post-chemotherapy amenorrhea, in premenopausal patients treated with these regimens.
  • Determine the effect of induction of post-chemotherapy amenorrhea on disease-free survival in premenopausal patients treated with these regimens.
  • Correlate post-chemotherapy amenorrhea and disease-free survival with hormone receptor status in premenopausal patients treated with these regimens.
  • Correlate changes in left ventricular ejection fraction (LVEF) with self-reported physical functioning in patients treated with these regimens.
  • Compare the efficacy of these regimens in patients with Human Epidermal Growth Factor Receptor 2 (HER2)/neu and/or topoisomerase-2-alpha gene amplification.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to hormone receptor status (estrogen receptor [ER] positive or progesterone receptor [PR] positive vs ER negative or PR negative) and type of prior surgery (lumpectomy vs total mastectomy). Patients are randomized to 1 of 2 treatment arms.

  • Arm 1: Patients receive doxorubicin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses.
  • Arm 2: Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

All patients with ER- or PR-positive tumors receive hormonal therapy daily beginning within 3-12 weeks after the completion of chemotherapy and continuing for at least 5 years.

All patients who have undergone prior lumpectomy undergo whole-breast radiotherapy beginning as soon as possible after the completion of chemotherapy. Patients who have undergone prior total mastectomy may undergo chest wall radiotherapy at the investigator's discretion. Patients assigned to the partial breast irradiation (PBI) group of protocol NSABP-B-39 undergo PBI according to protocol-specific guidelines.

Quality of life is assessed at baseline, on day 1 of course 4 of chemotherapy, and then every 6 months for 3 years.

Patients are followed every 6 months for up to 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 2,700 patients (1,350 per treatment arm) will be accrued for this study within 3.75 years.

Conditions
Breast Cancer
Being tested
cyclophosphamide, adriamycin, epirubicin, fluorouracil
Keywords
stage I breast cancer, stage II 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.

  • cyclophosphamideDrug

    Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles

  • adriamycinDrug

    Also called doxorubicin, doxorubicin hydrochloride

    adriamycin 60 mg/m2 IV every 21 days for 4 cycles

  • epirubicinDrug

    Also called epirubicin hydrochloride

    epirubicin 100 mg/m2 IV every 21 days for 6 cycles

  • fluorouracilDrug

    Also called 5-fluorouracil, 5-FU

    fluorouracil 500 mg/m2 IV every 21 days for 6 cycles

Study groups in NCT00087178
Study groupRoleWhat they receive
Arm 1: adriamycin + cyclophosphamideActive comparatorPatients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses.
Receives: Drug: cyclophosphamide; Drug: adriamycin
Arm 2: fluorouracil + epirubicin + cyclophosphamideExperimentalPatients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.
Receives: Drug: cyclophosphamide; Drug: epirubicin; Drug: fluorouracil

What is being measured

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

  1. Disease Free Survival

    Percentage of patients free from DFS event. DFS events include local, regional, or distant recurrence, second primary cancer or death from any cause prior to recurrence or second primary cancer

    Measured: 9 years

Secondary outcomes (8)

  1. Survival

    Percentage of patients alive

    Measured: 9 years

  2. Adverse Events

    Percentage of patients with at least one grade 2 or higher adverse event reported

    Measured: 9 years

  3. Quality of Life-Functional Assessment of Cancer Therapy

    Functional Assessment of Cancer Therapy (FACT-B) trial outcome index (TOI) score. FACT-B TOI score ranges from 0 to 92, with a higher score indicating better QOL.

    Measured: 12 months

  4. Post Chemotherapy Amenorrhea

    Percent with post chemotherapy amenorrhea

    Measured: 18 months

  5. Change in Left Ventricular Ejection Fraction (LVEF) at the 12-month Evaluation

    Change in LVEF from randomization to 12 months

    Measured: 12 months

  6. HER-2 and Topo II Gene Amplification

    Measured: 6 years

  7. Recurrence-free Interval

    Percentage of patients with local-regional recurrence or distant recurrence

    Measured: 9 years

  8. Distant Recurrence-free Interval

    Percentage of patients with distant recurrence

    Measured: 9 years

Timeline

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

  1. First posted12 Jul 2004 (estimated)
  2. Study startMay 2004
  3. Primary completionMar 2014
  4. Study completionMay 2016

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
2,722 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00087178
Sponsor's protocol ID
NSABP B-36
Other IDs
U10CA012027
Status last verified
Aug 2022
First submitted
8 Jul 2004
Last updated
11 Aug 2022
Data monitoring committee
Yes

Publications

  • Geyer CE Jr, Bandos H, Rastogi P, Jacobs SA, Robidoux A, Fehrenbacher L, Ward PJ, Polikoff J, Brufsky AM, Provencher L, Paterson AHG, Hamm JT, Carolla RL, Baez-Diaz L, Julian TB, Swain SM, Mamounas EP, Wolmark N. Definitive results of a phase III adjuvant trial comparing six cycles of FEC-100 to four cycles of AC in women with operable node-negative breast cancer: the NSABP B-36 trial (NRG Oncology). Breast Cancer Res Treat. 2022 Jun;193(3):555-564. doi: 10.1007/s10549-021-06417-y. Epub 2022 Mar 1.

    PubMed 35230585

  • Ganz PA, Bandos H, Geyer CE Jr, Robidoux A, Paterson AHG, Polikoff J, Baez-Diaz L, Brufsky AM, Fehrenbacher L, Parsons AW, Ward PJ, Provencher L, Hamm JT, Stella PJ, Carolla RL, Margolese RG, Shibata HR, Perez EA, Wolmark N. Behavioral and health outcomes from the NRG Oncology/NSABP B-36 trial comparing two different adjuvant therapy regimens for early-stage node-negative breast cancer. Breast Cancer Res Treat. 2022 Feb;192(1):153-161. doi: 10.1007/s10549-021-06475-2. Epub 2022 Feb 3.

    PubMed 35112166

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cyclophosphamide, adriamycin and epirubicin in people with Breast Cancer, run by NSABP Foundation Inc at 606 sites in 3 countries.

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

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 606 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Disease Free Survival (time frame: 9 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00087178, which also lists 2 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.

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