AzTrials
AzTrials

Breast CancerPhase 3NCT00016406

S0012 Doxorubicin, Cyclophosphamide, and Paclitaxel With or Without Filgrastim in Treating Women With Inflammatory or Locally Advanced Breast Cancer

A Phase 3 study testing filgrastim, cyclophosphamide and doxorubicin in people with Breast Cancer, run by SWOG Cancer Research Network at 314 sites in United States.

Completed

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

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether combination chemotherapy is more effective with or without filgrastim 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?
filgrastim, cyclophosphamide and doxorubicin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
399 participants
Where
314 sitesUnited States
Study dates
May 2001to Feb 2012
Phase
Phase 3
Are there results?
None posted in the registry

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed inflammatory or locally advanced breast cancer
  • Stage IIB (T3, N0, M0), IIIA (T3, N1-2, M0 or T0-2, N2, M0), or IIIB (T4, any N, M0 or any T, N3, M0)
  • Unresectable or otherwise appropriate for neoadjuvant therapy
  • Confirmed by core needle or incisional biopsy
  • Punch biopsy allowed if invasive disease is documented
  • No distant metastases
  • Hormone receptor status:
  • Not specified

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • SGOT or SGPT no greater than 2 times ULN

Renal:

  • Creatinine no greater than ULN

Cardiovascular:

  • No congestive heart failure or angina pectoris
  • LVEF greater than lower limit of normal

Other:

  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • HIV negative
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for breast cancer

Endocrine therapy:

  • No prior hormonal therapy for breast cancer

Radiotherapy:

  • No prior radiotherapy for breast cancer

Surgery:

  • No prior definitive surgery for breast cancer

Other:

  • No other concurrent anticancer therapy

Trial locations and contacts

314 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Kapiolani Medical Center at Pali Momi

    ‘Aiea, Hawaii, 96701

  • Oncology Services of Aberdeen

    Aberdeen, South Dakota, 57401

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87106

  • Lovelace Medical Center

    Albuquerque, New Mexico, 87108

  • 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

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • American Fork Hospital

    American Fork, Utah, 84003

  • Alaska Regional Hospital Cancer Center

    Anchorage, Alaska, 99508

  • Rose Ramer Cancer Clinic at Anderson Area Medical Center

    Anderson, South Carolina, 29621

  • Hope A Women's Cancer Center

    Asheville, North Carolina, 28801

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Auburn Regional Center for Cancer Care

    Auburn, Washington, 98002

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • Seton Shivers Cancer Program at Brackenridge Hospital

    Austin, Texas, 78701

  • CancerCare of Maine at Eastern Maine Medial Center

    Bangor, Maine, 04401

  • Baton Rouge General Regional Cancer Center

    Baton Rouge, Louisiana, 70806

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • St. Francis Hospital and Health Centers

    Beech Grove, Indiana, 46107

  • St. Joseph Hospital Community Cancer Center

    Bellingham, Washington, 98225

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • Mecosta County General Hospital

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Deaconess Billings Clinic - Downtown

    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

    Billings, Montana, 59101

  • Deaconess Billings Clinic Cancer Center

    Billings, Montana, 59107

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Cancer Care Center at Medcenter One Hospital

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, P. C.

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center

    Bismarck, North Dakota, 58501

  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • St. Luke's Mountain States Tumor Institute - Boise

    Boise, Idaho, 83712

  • Tufts - New England Medical Center

    Boston, Massachusetts, 02111

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Internal Medicine Associates of Bozeman

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • St. James Community Hospital

    Butte, Montana, 59701

  • St. Francis Medical Center

    Cape Girardeau, Missouri, 63701

  • Saint Anthony Regional Hospital

    Carroll, Iowa, 51401

  • St. Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Providence Centralia Hospital Regional Cancer Center

    Centralia, Washington, 98531

  • Cancer Center of Kansas, P.A. - Chanute

    Chanute, Kansas, 66720

  • Roper St. Francis Cancer Center at Roper Hospital

    Charleston, South Carolina, 29401

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • North Idaho Cancer Center

    Coeur d'Alene, Idaho, 83814

  • Memorial Hospital Cancer Center

    Colorado Springs, Colorado, 80909

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Genesis Regional Cancer Center at Genesis Medical Center

    Davenport, Iowa, 52803

  • Genesis Medical Center - West Campus

    Davenport, Iowa, 52804

  • 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

  • Halifax Medical Center

    Daytona Beach, Florida, 32115

  • 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

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48202

  • Cancer Center of Kansas, P.A. - Dodge City

    Dodge City, Kansas, 67801

  • Cancer Care Center at St. Luke's Hospital

    Duluth, Minnesota, 55805

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller-Dwan Medical Center

    Duluth, Minnesota, 55805

  • St. Mary's - Duluth Clinic Cancer Center

    Duluth, Minnesota, 55805

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas, P.A. - El Dorado

    El Dorado, Kansas, 67042

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

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

    Fort Lauderdale, Florida, 33308

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

    Fort Smith, Arkansas, 72903

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46815

  • Fremont Area Medical Center

    Fremont, Nebraska, 68025

  • Fremont Memorial Hospital

    Fremont, Ohio, 43420

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Medical and Surgical Specialists, L L C

    Galesburg, Illinois, 61401

  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

    Gape Girardeau, Missouri, 63701

  • Glendale Memorial Hospital Comprehensive Cancer Center

    Glendale, California, 91204

  • Legacy Mount Hood Medical Center

    Glesham, Oregon, 97030

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Center for Cancer Care at Goshen Health System

    Goshen, Indiana, 46527

  • Altru Cancer Center at Altru Hospital

    Grand Forks, North Dakota, 58201

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Mercy Medical Center

    Grand Rapids, Michigan, 49503

  • Spectrum Health Cancer Care - Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Metropolitan Hospital

    Grand Rapids, Michigan, 49506

  • Spectrum Health Hospital - Blodgett Campus

    Grand Rapids, Michigan, 49506

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Sletten Regional Cancer Institute

    Great Falls, Montana, 59405

  • Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital

    Greenville, North Carolina, 27858

  • Cancer Care Center at Catskill Regional Medical Center

    Harris, New York, 12742

  • Saint Rose Hospital

    Hayward, California, 94545

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Holland Community Hospital

    Holland, Michigan, 49423

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Cancer Research Center of Hawaii

    Honolula, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Lusitana

    Honolulu, Hawaii, 96813

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

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital, Incorporated

    Honolulu, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Kuakini

    Honolulu, Hawaii, 96817

  • St. Francis Medical Center

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224-9980

  • Joliet Oncology Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Borgess Medical Center

    Kalamazooaa, Michigan, 49001

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Good Samaritan Health Systems

    Kearney, Nebraska, 68847

  • Kenton Oncology, Incorporated

    Kenton, Ohio, 43326

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Cancer Center of Kansas, P.A. - Kingman

    Kingman, Kansas, 67068

  • Lenoir Memorial Cancer Center

    Kinston, North Carolina, 28501

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236

  • Haematology-Oncology Associates of Ohio and Michigan, P.C.

    Lambertville, Michigan, 48144

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Meeker County Memorial Hospital

    Litchfield, Minnesota, 55355

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

    Little Rock, Arkansas, 72205

  • Valley Memorial Hospital

    Livermore, California, 94550

  • Logan Regional Hospital

    Logan, Utah, 84321

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033-0804

  • UMC Southwest Cancer and Research Center

    Lubbock, Texas, 79415

  • MedCentral - Mansfield Hospital

    Mansfield, Ohio, 44903

  • St. John's Hospital

    Maplewood, Minnesota, 55109

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537

  • St. Luke's Hospital

    Maumee, Ohio, 43537

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Middletown Regional Hospital

    Middletown, Ohio, 45044

  • Eastern Montana Cancer Center

    Miles City, Montana, 59301

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Community Medical Center

    Missoula, Montana, 59801

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59802

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59802

  • Alegent Health Community Memorial Hospital

    Missouri Valley, Iowa, 51555

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36607

  • Trinity Medical Center - East

    Moline, Illinois, 61265

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital System

    Monroe, Michigan, 48162

  • Ted B. Wahby Cancer Center at Mount Clemens General Hospital

    Mount Clemens, Michigan, 48043

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98273

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Hackley Hospital

    Muskegon, Michigan, 49443

  • Hematology Oncology Consultants Ltd.

    Naperville, Illinois, 60540

  • Edward Hospital Cancer Center

    Naperville, Illinois, 60566

  • MBCCOP - Meharry Medical College - Nashville

    Nashville, Tennessee, 37208-3599

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Medical Center of Louisiana - New Orleans

    New Orleans, Louisiana, 70112

  • St. Vincent's Comprehensive Cancer Center - Manhattan

    New York, New York, 10011

  • Cancer Center of Kansas, P.A. - Newton

    Newton, Kansas, 67114

  • Highland General Hospital at St. George's University School of Medicine

    Oakland, California, 94602

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Summit Medical Center

    Oakland, California, 94609

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Providence St. Peter Hospital Regional Cancer Center

    Olympia, Washington, 95806

  • Capital Medical Center

    Olympia, Washington, 98507

  • Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields

    Olympia Fields, Illinois, 60461

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • Burgess Health Center

    Onawa, Iowa, 51040

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic - Oregon

    Oregon, Ohio, 43616

  • Comprehensive Cancer Center at Desert Regional Medical Center

    Palm Springs, California, 92262

  • Midlands Cancer Center at Midlands Community Hospital

    Papillion, Nebraska, 68046

  • Cancer Center of Kansas, P.A. - Parsons

    Parsons, Kansas, 67357

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Olympic Medical Center

    Port Angeles, Washington, 98362

  • Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center

    Portland, Oregon, 97210

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Institute of Oncology at Vilnius University

    Portland, Oregon, 97227

  • Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97239

  • Cancer Center of Kansas, P.A. - Pratt

    Pratt, Kansas, 67124

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84603

  • Good Samaritan Cancer Center

    Puyallup, Washington, 98372

  • Commonwealth Hematology-Oncology P. C. - Quincy

    Quincy, Massachusetts, 02169

  • All Saints Cancer Center at All Saints Healthcare

    Racine, Wisconsin, 53405

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Valley Medical Center

    Renton, Washington, 98055

  • Hubert H. Humphrey Cancer Center at North Memorial Medical Center

    Robbinsdale, Minnesota, 55422

  • Highland Hospital of Rochester

    Rochester, New York, 14620

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Swedish American Hospital

    Rockford, Illinois, 61104

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Health Services

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • St. Joseph's Hospital

    Saint Paul, Minnesota, 55102

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Salem Hospital Regional Cancer Center

    Salem, Oregon, 97309

  • Cancer Center of Kansas, P.A. - Salina

    Salina, Kansas, 67042

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas, 78209

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900

  • Cancer Therapy and Research Center

    San Antonio, Texas, 78229

  • University Hospital - San Antonio

    San Antonio, Texas, 78229

  • J.C. Robinson, M.D. Regional Cancer Center

    San Pablo, California, 94806

  • Firelands Regional Medical Center

    Sandusky, Ohio, 44870

  • North Coast Cancer Care, Incorporated

    Sandusky, Ohio, 44870

  • New Mexico Cancer Care Associates

    Santa Fe, New Mexico, 87505

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • Group Health Central Hospital

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98114

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195

  • North Puget Oncology at United General Hospital

    Sedro-Woolley, Washington, 98284

  • Saint Francis Cancer Center

    Shakopee, Minnesota, 55379

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Cancer Treatment Center at Christus Schumpert St. Mary Place

    Shreveport, Louisiana, 71101

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101-1733

  • Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center

    Sioux City, Iowa, 51101

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51104

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Providence Cancer Institute at Providence Hospital - Southfield Campus

    Southfield, Michigan, 48075

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29304

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Highlands Oncology Group - Springdale

    Springdale, Arkansas, 72764

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • David C. Pratt Cancer Center at St. John's Mercy

    St Louis, Missouri, 63141

  • Dixie Regional Medical Center

    St. George, Utah, 84770

  • Promedica Cancer Center at Flower Hospital

    Sylvania, Ohio, 43560

  • Allenmore Hospital

    Tacoma, Washington, 98405

  • CCOP - Northwest

    Tacoma, Washington, 98405

  • St. Joseph Medical Center at Franciscan Health System

    Tacoma, Washington, 98405

  • Madigan Army Medical Center

    Tacoma, Washington, 98431

  • St. Clare Hospital

    Tacoma, Washington, 98499

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • Toledo Hospital

    Toledo, Ohio, 43606

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Medical College of Ohio Cancer Institute

    Toledo, Ohio, 43614

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43623

  • Toledo Clinic, Incorporated - Main Clinic

    Toledo, Ohio, 43623

  • Toledo Surgical Specialists

    Toledo, Ohio, 43623

  • Stormont-Vail Cancer Center

    Topeka, Kansas, 66604

  • St. Francis Comprehensive Cancer Center

    Topeka, Kansas, 66606

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Southwest Washington Medical Center Cancer Center

    Vancouver, Washington, 98668

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • Cancer Center of Kansas, P.A. - Wellington

    Wellington, Kansas, 67152

  • Central Washington Hospital

    Wenatchee, Washington, 98801

  • Wenatchee Valley Clinic

    Wenatchee, Washington, 98801

Other trials in United States

About this study

Official title: A Comparative Randomized Study of Standard Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel Vs. Weekly Doxorubicin and Daily Oral Cyclophosphamide Plus G-CSF Followed by Weekly Paclitaxel As Neoadjuvant Therapy For Inflammatory and Locally Advanced Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether combination chemotherapy is more effective with or without filgrastim in treating breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combining doxorubicin, cyclophosphamide, and paclitaxel with or without filgrastim in treating women who have inflammatory or locally advanced breast cancer.

Read the detailed description

OBJECTIVES:

  • Compare the microscopic pathologic response rates in women with inflammatory or locally advanced breast cancer treated with standard neoadjuvant doxorubicin and cyclophosphamide followed by weekly paclitaxel vs weekly doxorubicin and daily oral cyclophosphamide with filgrastim (G-CSF) followed by weekly paclitaxel.
  • Compare the toxic effects of these regimens in this patient population.
  • Compare the delivered dose intensity of these regimens in this patient population.
  • Evaluate the association between microscopic pathologic complete response and clinical complete response at the primary tumor site in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease status (inflammatory vs other). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive doxorubicin IV followed by cyclophosphamide IV on day 1. Treatment repeats every 21 days for a total of 5 courses in the absence of disease progression or unacceptable toxicity. Three weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour weekly on day 1 for a total of 12 weeks.
  • Arm II: Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and filgrastim (G-CSF) subcutaneously on days 2-7. Treatment repeats weekly for a total of 15 courses of doxorubicin and cyclophosphamide and 16 courses of G-CSF in the absence of disease progression or unacceptable toxicity. One week after completion of G-CSF, patients receive paclitaxel as in arm I.

Within 3-6 weeks after completion of chemotherapy, patients with stable or responsive disease undergo surgical resection of tumor and affected nodes.

After surgery, patients may receive radiotherapy or additional chemotherapy and/or hormonal therapy at the discretion of the treating physician.

Patients are followed every 6 months for 1 year and then annually for 4 years.

PROJECTED ACCRUAL: A total of 350 patients (175 per treatment arm) will be accrued for this study within 3 years.

Conditions
Breast Cancer
Keywords
stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, inflammatory breast cancer
Medical subject headings
Breast Neoplasms, Inflammatory Breast Neoplasms

What participants receive

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

Study groups in NCT00016406
Study groupRoleWhat they receive
AC followed by PActive comparatordoxorubicin and cyclophosphamide followed by paclitaxel followed by surgery
Receives: Drug: cyclophosphamide; Drug: doxorubicin; Drug: paclitaxel; Procedure: surgery
AC+G followed by PExperimentalweekly doxorubicin and daily cyclophosphamide with filgrastim followed by paclitaxel followed by surgery
Receives: Biological: filgrastim; Drug: cyclophosphamide; Drug: doxorubicin; Drug: paclitaxel; Procedure: surgery

What is being measured

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

  1. Comparison of microscopic pathologic response rates

    Measured: no sooner than 21 days after chemo

  2. Toxicity

    Measured: during chemo and at surgery

  3. Comparison of delivered dose intensity

    Measured: after chemo

  4. Correlation of microscopic pathologic complete response with clinical complete response at the primary tumor site

    Measured: no sooner than 21 days after chemo

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startMay 2001
  3. Primary completionSep 2006
  4. Study completionFeb 2012

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
399 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00016406
Sponsor's protocol ID
CDR0000068630
Other IDs
S0012, U10CA032102
Status last verified
Jan 2013
First submitted
6 May 2001
Last updated
24 Jan 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Slovak ML, Bedell V, Lew D, et al.: Screening for clonal hematopoiesis as a predictive marker for development of t-AML following adjuvant therapy for breast cancer (S0012). [Abstract] J Clin Oncol 25 (Suppl 18): A-11051, 2007.

  • Ellis GK, Barlow WE, Gralow JR, Hortobagyi GN, Russell CA, Royce ME, Perez EA, Lew D, Livingston RB. Phase III comparison of standard doxorubicin and cyclophosphamide versus weekly doxorubicin and daily oral cyclophosphamide plus granulocyte colony-stimulating factor as neoadjuvant therapy for inflammatory and locally advanced breast cancer: SWOG 0012. J Clin Oncol. 2011 Mar 10;29(8):1014-21. doi: 10.1200/JCO.2009.27.6543. Epub 2011 Jan 10.

    PubMed 21220618

  • Slovak ML, Bedell V, Lew D, Albain KS, Ellis GK, Livingston RB, Martino S, Perez EA, Hortobagyi GN, Sher D, Stock W. Screening for clonal hematopoiesis as a predictive marker for development of therapy-related myeloid neoplasia (t-MN) following neoadjuvant therapy for breast cancer: a Southwest Oncology Group study (S0012). Breast Cancer Res Treat. 2010 Jan;119(2):391-8. doi: 10.1007/s10549-009-0597-5.

    PubMed 19851858

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing filgrastim, cyclophosphamide and doxorubicin in people with Breast Cancer, run by SWOG Cancer Research Network at 314 sites in United States.

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

Who may be eligible to take part?

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 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 314 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Comparison of microscopic pathologic response rates (time frame: no sooner than 21 days after chemo). The study lists 4 primary outcomes in all. 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 NCT00016406, which also lists 3 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 24 Jan 2013.

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