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

January 23, 2013 updated by: Southwest Oncology Group

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.

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

399

Phase

Phase 3

Contacts and Locations

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

Study Locations

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

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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

Study Plan

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

How is the study designed?

Design Details

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

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AC followed by P doxorubicin and cyclophosphamide followed by paclitaxel followed by surgery	Drug: cyclophosphamide Other Names: cytoxan Procedure: surgery Drug: paclitaxel Drug: doxorubicin Other Names: Adriamycin
Experimental: AC+G followed by P weekly doxorubicin and daily cyclophosphamide with filgrastim followed by paclitaxel followed by surgery	Drug: cyclophosphamide Other Names: cytoxan Procedure: surgery Drug: paclitaxel Biological: filgrastim Other Names: G-CSF Drug: doxorubicin Other Names: Adriamycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of microscopic pathologic response rates Time Frame: no sooner than 21 days after chemo	no sooner than 21 days after chemo
Toxicity Time Frame: during chemo and at surgery	during chemo and at surgery
Comparison of delivered dose intensity Time Frame: after chemo	after chemo
Correlation of microscopic pathologic complete response with clinical complete response at the primary tumor site Time Frame: no sooner than 21 days after chemo	no sooner than 21 days after chemo

Collaborators and Investigators

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

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Georgiana K. Ellis, MD, Seattle Cancer Care Alliance

Publications and helpful links

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

General Publications

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.
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.

Study record dates

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

Study Major Dates

Study Start

May 1, 2001

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

May 6, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000068630
U10CA032102 (U.S. NIH Grant/Contract)
S0012 (Other Identifier: SWOG)

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

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

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers