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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00016406
First received: May 6, 2001
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Biological: filgrastim
Drug: cyclophosphamide
Drug: doxorubicin
Drug: paclitaxel
Procedure: surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Comparison of microscopic pathologic response rates [ Time Frame: no sooner than 21 days after chemo ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: during chemo and at surgery ] [ Designated as safety issue: Yes ]
  • Comparison of delivered dose intensity [ Time Frame: after chemo ] [ Designated as safety issue: No ]
  • Correlation of microscopic pathologic complete response with clinical complete response at the primary tumor site [ Time Frame: no sooner than 21 days after chemo ] [ Designated as safety issue: No ]

Enrollment: 399
Study Start Date: May 2001
Study Completion Date: February 2012
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AC followed by P
doxorubicin and cyclophosphamide followed by paclitaxel followed by surgery
Drug: cyclophosphamide
Other Name: cytoxan
Drug: doxorubicin
Other Name: Adriamycin
Drug: paclitaxel Procedure: surgery
Experimental: AC+G followed by P
weekly doxorubicin and daily cyclophosphamide with filgrastim followed by paclitaxel followed by surgery
Biological: filgrastim
Other Name: G-CSF
Drug: cyclophosphamide
Other Name: cytoxan
Drug: doxorubicin
Other Name: Adriamycin
Drug: paclitaxel Procedure: surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016406

  Hide Study Locations
Locations
United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
United States, Alaska
Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States, 99508
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks, Alaska, United States, 99701
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, Arkansas
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Ft. Smith, Arkansas, United States, 72903
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Highlands Oncology Group - Springdale
Springdale, Arkansas, United States, 72764
United States, California
Glendale Memorial Hospital Comprehensive Cancer Center
Glendale, California, United States, 91204
Saint Rose Hospital
Hayward, California, United States, 94545
Valley Memorial Hospital
Livermore, California, United States, 94550
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609
Highland General Hospital at St. George's University School of Medicine
Oakland, California, United States, 94602
Summit Medical Center
Oakland, California, United States, 94609
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, United States, 92262
J.C. Robinson, M.D. Regional Cancer Center
San Pablo, California, United States, 94806
United States, Colorado
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States, 80909
United States, Florida
Halifax Medical Center
Daytona Beach, Florida, United States, 32115
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224-9980
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States, 33458
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Hawaii
Kapiolani Medical Center at Pali Momi
Aiea, Hawaii, United States, 96701
Cancer Research Center of Hawaii
Honolula, Hawaii, United States, 96813
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
OnCare Hawaii, Incorporated - Kuakini
Honolulu, Hawaii, United States, 96817
OnCare Hawaii, Incorporated - Lusitana
Honolulu, Hawaii, United States, 96813
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, United States, 96813
St. Francis Medical Center
Honolulu, Hawaii, United States, 96817
Straub Clinic and Hospital, Incorporated
Honolulu, Hawaii, United States, 96813
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859
United States, Idaho
St. Luke's Mountain States Tumor Institute - Boise
Boise, Idaho, United States, 83712
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
North Idaho Cancer Center
Coeur D'Alene, Idaho, United States, 83814
United States, Illinois
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States, 62002
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
Medical and Surgical Specialists, L L C
Galesburg, Illinois, United States, 61401
Joliet Oncology Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Trinity Medical Center - East
Moline, Illinois, United States, 61265
Good Samaritan Regional Health Center
Mt. Vernon, Illinois, United States, 62864
Hematology Oncology Consultants Ltd.
Naperville, Illinois, United States, 60540
Edward Hospital Cancer Center
Naperville, Illinois, United States, 60566
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
Olympia Fields, Illinois, United States, 60461
Swedish American Hospital
Rockford, Illinois, United States, 61104
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
St. Francis Hospital and Health Centers
Beech Grove, Indiana, United States, 46107
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46815
Center for Cancer Care at Goshen Health System
Goshen, Indiana, United States, 46527
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
United States, Iowa
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States, 52722
Saint Anthony Regional Hospital
Carroll, Iowa, United States, 51401
St. Luke's Hospital
Cedar Rapids, Iowa, United States, 52402
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
Alegent Health Mercy Hospital
Council Bluffs, Iowa, United States, 51503
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, United States, 52803
Genesis Medical Center - West Campus
Davenport, Iowa, United States, 52804
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
Alegent Health Community Memorial Hospital
Missouri Valley, Iowa, United States, 51555
Burgess Health Center
Onawa, Iowa, United States, 51040
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
Sioux City, Iowa, United States, 51101
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101-1733
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, United States, 50266
United States, Kansas
Cancer Center of Kansas, P.A. - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, P.A. - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas, United States, 67042
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Cancer Center of Kansas, P.A. - Kingman
Kingman, Kansas, United States, 67068
Southwest Medical Center
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, P.A. - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, P.A. - Pratt
Pratt, Kansas, United States, 67124
Salina Regional Health Center
Salina, Kansas, United States, 67401
Cancer Center of Kansas, P.A. - Salina
Salina, Kansas, United States, 67042
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States, 66606
Stormont-Vail Cancer Center
Topeka, Kansas, United States, 66604
Cancer Center of Kansas, P.A. - Wellington
Wellington, Kansas, United States, 67152
CCOP - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, P.A. - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, United States, 67214
Associates in Womens Health, P.A. - North Review
Wichita, Kansas, United States, 67203
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, P.A. - Winfield
Winfield, Kansas, United States, 67156
United States, Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536
United States, Louisiana
Baton Rouge General Regional Cancer Center
Baton Rouge, Louisiana, United States, 70806
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States, 70809
Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, United States, 70112
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Cancer Treatment Center at Christus Schumpert St. Mary Place
Shreveport, Louisiana, United States, 71101
United States, Maine
CancerCare of Maine at Eastern Maine Medial Center
Bangor, Maine, United States, 04401
United States, Massachusetts
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States, 02118
Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
Commonwealth Hematology-Oncology P. C. - Quincy
Quincy, Massachusetts, United States, 02169
United States, Michigan
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
Mecosta County General Hospital
Big Rapids, Michigan, United States, 49307
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48202
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
Lacks Cancer Center at Saint Mary's Mercy Medical Center
Grand Rapids, Michigan, United States, 49503
Spectrum Health Hospital - Blodgett Campus
Grand Rapids, Michigan, United States, 49506
Spectrum Health Cancer Care - Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Metropolitan Hospital
Grand Rapids, Michigan, United States, 49506
Holland Community Hospital
Holland, Michigan, United States, 49423
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center
Kalamazooaa, Michigan, United States, 49001
Haematology-Oncology Associates of Ohio and Michigan, P.C.
Lambertville, Michigan, United States, 48144
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Mercy Memorial Hospital System
Monroe, Michigan, United States, 48162
Ted B. Wahby Cancer Center at Mount Clemens General Hospital
Mount Clemens, Michigan, United States, 48043
Hackley Hospital
Muskegon, Michigan, United States, 49443
Northern Michigan Hospital
Petoskey, Michigan, United States, 49770
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, United States, 48075
Munson Medical Center
Traverse City, Michigan, United States, 49684
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Miller-Dwan Medical Center
Duluth, Minnesota, United States, 55805
Cancer Care Center at St. Luke's Hospital
Duluth, Minnesota, United States, 55805
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States, 55805
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Meeker County Memorial Hospital
Litchfield, Minnesota, United States, 55355
St. John's Hospital
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, United States, 55101
Saint Francis Cancer Center
Shakopee, Minnesota, United States, 55379
St. Joseph's Hospital
St Paul, Minnesota, United States, 55102
Park Nicollet Health Services
St. Louis Park, Minnesota, United States, 55416
United Hospital
St. Paul, Minnesota, United States, 55102
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Woodwinds Hospital
Woodbury, Minnesota, United States, 55125
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
St. Francis Medical Center
Cape Girardeau, Missouri, United States, 63701
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Gape Girardeau, Missouri, United States, 63701
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
David C. Pratt Cancer Center at St. John's Mercy
St. Louis, Missouri, United States, 63141
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, United States, 63141
Missouri Baptist Cancer Center
St. Louis, Missouri, United States, 63131
United States, Montana
Deaconess Billings Clinic - Downtown
Billings, Montana, United States, 59101
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
St. Vincent Healthcare
Billings, Montana, United States, 59101
Deaconess Billings Clinic Cancer Center
Billings, Montana, United States, 59107
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Internal Medicine Associates of Bozeman
Bozeman, Montana, United States, 59715
St. James Community Hospital
Butte, Montana, United States, 59701
Great Falls Clinic
Great Falls, Montana, United States, 59405
Sletten Regional Cancer Institute
Great Falls, Montana, United States, 59405
St. Peter's Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Eastern Montana Cancer Center
Miles City, Montana, United States, 59301
Community Medical Center
Missoula, Montana, United States, 59801
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59802
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59802
United States, Nebraska
Fremont Area Medical Center
Fremont, Nebraska, United States, 68025
Good Samaritan Health Systems
Kearney, Nebraska, United States, 68847
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, United States, 68046
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
United States, New Mexico
Lovelace Medical Center
Albuquerque, New Mexico, United States, 87108
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87106
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States, 87505
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Cancer Care Center at Catskill Regional Medical Center
Harris, New York, United States, 12742
St. Vincent's Comprehensive Cancer Center - Manhattan
New York, New York, United States, 10011
Highland Hospital of Rochester
Rochester, New York, United States, 14620
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Hope A Women's Cancer Center
Asheville, North Carolina, United States, 28801
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
Greenville, North Carolina, United States, 27858
Lenoir Memorial Cancer Center
Kinston, North Carolina, United States, 28501
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Mid Dakota Clinic, P. C.
Bismarck, North Dakota, United States, 58501
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
Cancer Care Center at Medcenter One Hospital
Bismarck, North Dakota, United States, 58501
St. Alexius Medical Center
Bismarck, North Dakota, United States, 58501
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States, 58201
United States, Ohio
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Grandview Hospital
Dayton, Ohio, United States, 45405
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
CCOP - Dayton
Dayton, Ohio, United States, 45429
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Fremont Memorial Hospital
Fremont, Ohio, United States, 43420
Kenton Oncology, Incorporated
Kenton, Ohio, United States, 43326
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Lima Memorial Hospital
Lima, Ohio, United States, 45804
St. Rita's Medical Center
Lima, Ohio, United States, 45801
MedCentral - Mansfield Hospital
Mansfield, Ohio, United States, 44903
St. Luke's Hospital
Maumee, Ohio, United States, 43537
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537
Middletown Regional Hospital
Middletown, Ohio, United States, 45044
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
Promedica Cancer Center at Flower Hospital
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Medical College of Ohio Cancer Institute
Toledo, Ohio, United States, 43614
Toledo Hospital
Toledo, Ohio, United States, 43606
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623
Toledo Surgical Specialists
Toledo, Ohio, United States, 43623
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373
Fulton County Health Center
Wauseon, Ohio, United States, 43567
United States Air Force Medical Center Wright-Patterson
Wright-Patterson Afb, Ohio, United States, 45433-5529
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Legacy Mount Hood Medical Center
Glesham, Oregon, United States, 97030
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Institute of Oncology at Vilnius University
Portland, Oregon, United States, 97227
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Portland, Oregon, United States, 97210
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Salem Hospital Regional Cancer Center
Salem, Oregon, United States, 97309
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States, 18105
Jennersville Regional Hospital
West Grove, Pennsylvania, United States, 19390
United States, South Carolina
Rose Ramer Cancer Clinic at Anderson Area Medical Center
Anderson, South Carolina, United States, 29621
Roper St. Francis Cancer Center at Roper Hospital
Charleston, South Carolina, United States, 29401
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29304
United States, South Dakota
Oncology Services of Aberdeen
Aberdeen, South Dakota, United States, 57401
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
United States, Tennessee
MBCCOP - Meharry Medical College - Nashville
Nashville, Tennessee, United States, 37208-3599
United States, Texas
Harrington Cancer Center
Amarillo, Texas, United States, 79106
Seton Shivers Cancer Program at Brackenridge Hospital
Austin, Texas, United States, 78701
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Wilford Hall Medical Center
Lackland AFB, Texas, United States, 78236
UMC Southwest Cancer and Research Center
Lubbock, Texas, United States, 79415
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78209
University Hospital - San Antonio
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Utah
American Fork Hospital
American Fork, Utah, United States, 84003
Logan Regional Hospital
Logan, Utah, United States, 84321
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84603
LDS Hospital
Salt Lake City, Utah, United States, 84143
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
Dixie Regional Medical Center
St. George, Utah, United States, 84770
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
United States, Washington
Auburn Regional Center for Cancer Care
Auburn, Washington, United States, 98002
St. Joseph Hospital Community Cancer Center
Bellingham, Washington, United States, 98225
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
Providence Centralia Hospital Regional Cancer Center
Centralia, Washington, United States, 98531
St. Francis Hospital
Federal Way, Washington, United States, 98003
Skagit Valley Hospital Cancer Care Center
Mt. Vernon, Washington, United States, 98273
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, United States, 95806
Capital Medical Center
Olympia, Washington, United States, 98507
Olympic Medical Center
Port Angeles, Washington, United States, 98362
Good Samaritan Cancer Center
Puyallup, Washington, United States, 98372
Valley Medical Center
Renton, Washington, United States, 98055
Group Health Central Hospital
Seattle, Washington, United States, 98104
Harborview Medical Center
Seattle, Washington, United States, 98104
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98114
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
North Puget Oncology at United General Hospital
Sedro-Wooley, Washington, United States, 98284
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Allenmore Hospital
Tacoma, Washington, United States, 98405
St. Joseph Medical Center at Franciscan Health System
Tacoma, Washington, United States, 98405
CCOP - Northwest
Tacoma, Washington, United States, 98405
St. Clare Hospital
Tacoma, Washington, United States, 98499
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States, 98668
Central Washington Hospital
Wenatchee, Washington, United States, 98801
Wenatchee Valley Clinic
Wenatchee, Washington, United States, 98801
Washington Hematology - Oncology Specialists
Yakima, Washington, United States, 98902
North Star Lodge Cancer Center
Yakima, Washington, United States, 98902
United States, Wisconsin
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, United States, 53405
United States, Wyoming
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Georgiana K. Ellis, MD Seattle Cancer Care Alliance
  More Information

Additional Information:
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, Green SJ, Russell CA, et al.: SWOG 0012, a randomized phase III comparison of standard doxorubicin (A) and cyclophosphamide (C) followed by weekly paclitaxel (T) versus weekly doxorubicin and daily oral cyclophosphamide plus G-CSF (G) followed by weekly paclitaxel as neoadjuvant therapy for inflammatory and locally advanced breast cancer. [Abstract] J Clin Oncol 24 (Suppl 18): A-LBA537, 2006.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00016406     History of Changes
Other Study ID Numbers: CDR0000068630, S0012, U10CA032102
Study First Received: May 6, 2001
Last Updated: January 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
inflammatory breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Doxorubicin
Paclitaxel
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on April 22, 2014