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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00016406
• Other study ID #: CDR0000068630
• Secondary ID: S0012U10CA032102
• Status: Completed
• Phase: Phase 3
• First received: May 6, 2001
• Last updated: January 23, 2013
• Start date: May 2001
• Est. completion date: February 2012

Study information

• Verified date: January 2013
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: February 2012
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• filgrastim

Drug:
• cyclophosphamide

• doxorubicin

• paclitaxel

Procedure:
• surgery

Locations

Country	Name	City	State
United States	Oncology Services of Aberdeen	Aberdeen	South Dakota
United States	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan
United States	Kapiolani Medical Center at Pali Momi	Aiea	Hawaii
United States	Lovelace Medical Center	Albuquerque	New Mexico
United States	University of New Mexico Cancer Research and Treatment Center	Albuquerque	New Mexico
United States	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania
United States	Saint Anthony's Hospital at Saint Anthony's Health Center	Alton	Illinois
United States	Harrington Cancer Center	Amarillo	Texas
United States	American Fork Hospital	American Fork	Utah
United States	Alaska Regional Hospital Cancer Center	Anchorage	Alaska
United States	Rose Ramer Cancer Clinic at Anderson Area Medical Center	Anderson	South Carolina
United States	Hope A Women's Cancer Center	Asheville	North Carolina
United States	Mission Hospitals - Memorial Campus	Asheville	North Carolina
United States	Auburn Regional Center for Cancer Care	Auburn	Washington
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	Seton Shivers Cancer Program at Brackenridge Hospital	Austin	Texas
United States	CancerCare of Maine at Eastern Maine Medial Center	Bangor	Maine
United States	Baton Rouge General Regional Cancer Center	Baton Rouge	Louisiana
United States	Mary Bird Perkins Cancer Center - Baton Rouge	Baton Rouge	Louisiana
United States	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan
United States	St. Francis Hospital and Health Centers	Beech Grove	Indiana
United States	St. Joseph Hospital Community Cancer Center	Bellingham	Washington
United States	Hematology Oncology Associates of the Quad Cities	Bettendorf	Iowa
United States	Mecosta County General Hospital	Big Rapids	Michigan
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Deaconess Billings Clinic - Downtown	Billings	Montana
United States	Deaconess Billings Clinic Cancer Center	Billings	Montana
United States	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana
United States	Northern Rockies Radiation Oncology Center	Billings	Montana
United States	St. Vincent Healthcare	Billings	Montana
United States	Bismarck Cancer Center	Bismarck	North Dakota
United States	Cancer Care Center at Medcenter One Hospital	Bismarck	North Dakota
United States	Mid Dakota Clinic, P. C.	Bismarck	North Dakota
United States	St. Alexius Medical Center	Bismarck	North Dakota
United States	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center	Boise	Idaho
United States	St. Luke's Mountain States Tumor Institute - Boise	Boise	Idaho
United States	Cancer Research Center at Boston Medical Center	Boston	Massachusetts
United States	Tufts - New England Medical Center	Boston	Massachusetts
United States	Wood County Oncology Center	Bowling Green	Ohio
United States	Bozeman Deaconess Hospital	Bozeman	Montana
United States	Internal Medicine Associates of Bozeman	Bozeman	Montana
United States	Olympic Hematology and Oncology	Bremerton	Washington
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	St. James Community Hospital	Butte	Montana
United States	St. Francis Medical Center	Cape Girardeau	Missouri
United States	Saint Anthony Regional Hospital	Carroll	Iowa
United States	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa
United States	Mercy Regional Cancer Center at Mercy Medical Center	Cedar Rapids	Iowa
United States	St. Luke's Hospital	Cedar Rapids	Iowa
United States	Providence Centralia Hospital Regional Cancer Center	Centralia	Washington
United States	Cancer Center of Kansas, P.A. - Chanute	Chanute	Kansas
United States	Roper St. Francis Cancer Center at Roper Hospital	Charleston	South Carolina
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	North Idaho Cancer Center	Coeur D'Alene	Idaho
United States	Memorial Hospital Cancer Center	Colorado Springs	Colorado
United States	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota
United States	Alegent Health Mercy Hospital	Council Bluffs	Iowa
United States	Medical City Dallas Hospital	Dallas	Texas
United States	Danville Regional Medical Center	Danville	Virginia
United States	Genesis Medical Center - West Campus	Davenport	Iowa
United States	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa
United States	CCOP - Dayton	Dayton	Ohio
United States	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio
United States	Good Samaritan Hospital	Dayton	Ohio
United States	Grandview Hospital	Dayton	Ohio
United States	Samaritan North Cancer Care Center	Dayton	Ohio
United States	Veterans Affairs Medical Center - Dayton	Dayton	Ohio
United States	Halifax Medical Center	Daytona Beach	Florida
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa
United States	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa
United States	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa
United States	Mercy Capitol Hospital	Des Moines	Iowa
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Cancer Center of Kansas, P.A. - Dodge City	Dodge City	Kansas
United States	Cancer Care Center at St. Luke's Hospital	Duluth	Minnesota
United States	CCOP - Duluth	Duluth	Minnesota
United States	Miller-Dwan Medical Center	Duluth	Minnesota
United States	St. Mary's - Duluth Clinic Cancer Center	Duluth	Minnesota
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Cancer Center of Kansas, P.A. - El Dorado	El Dorado	Kansas
United States	Englewood Hospital and Medical Center	Englewood	New Jersey
United States	Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital	Fairbanks	Alaska
United States	St. Francis Hospital	Federal Way	Washington
United States	Blanchard Valley Medical Associates	Findlay	Ohio
United States	Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital	Fort Lauderdale	Florida
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana
United States	Fremont Area Medical Center	Fremont	Nebraska
United States	Fremont Memorial Hospital	Fremont	Ohio
United States	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota
United States	Hembree Mercy Cancer Center at St. Edward Mercy Medical Center	Ft. Smith	Arkansas
United States	Medical and Surgical Specialists, L L C	Galesburg	Illinois
United States	Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital	Gape Girardeau	Missouri
United States	Glendale Memorial Hospital Comprehensive Cancer Center	Glendale	California
United States	Legacy Mount Hood Medical Center	Glesham	Oregon
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Center for Cancer Care at Goshen Health System	Goshen	Indiana
United States	Altru Cancer Center at Altru Hospital	Grand Forks	North Dakota
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	Lacks Cancer Center at Saint Mary's Mercy Medical Center	Grand Rapids	Michigan
United States	Metropolitan Hospital	Grand Rapids	Michigan
United States	Spectrum Health Cancer Care - Butterworth Campus	Grand Rapids	Michigan
United States	Spectrum Health Hospital - Blodgett Campus	Grand Rapids	Michigan
United States	Great Falls Clinic	Great Falls	Montana
United States	Sletten Regional Cancer Institute	Great Falls	Montana
United States	Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital	Greenville	North Carolina
United States	Cancer Care Center at Catskill Regional Medical Center	Harris	New York
United States	Saint Rose Hospital	Hayward	California
United States	St. Peter's Hospital	Helena	Montana
United States	Holland Community Hospital	Holland	Michigan
United States	Memorial Cancer Institute at Memorial Regional Hospital	Hollywood	Florida
United States	Cancer Research Center of Hawaii	Honolula	Hawaii
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	OnCare Hawaii, Incorporated - Kuakini	Honolulu	Hawaii
United States	OnCare Hawaii, Incorporated - Lusitana	Honolulu	Hawaii
United States	Queen's Cancer Institute at Queen's Medical Center	Honolulu	Hawaii
United States	St. Francis Medical Center	Honolulu	Hawaii
United States	Straub Clinic and Hospital, Incorporated	Honolulu	Hawaii
United States	Tripler Army Medical Center	Honolulu	Hawaii
United States	Hutchinson Area Health Care	Hutchinson	Minnesota
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Joliet Oncology Hematology Associates, Limited - West	Joliet	Illinois
United States	Ella Milbank Foshay Cancer Center at Jupiter Medical Center	Jupiter	Florida
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Borgess Medical Center	Kalamazooaa	Michigan
United States	Glacier Oncology, PLLC	Kalispell	Montana
United States	Kalispell Medical Oncology	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas
United States	Good Samaritan Health Systems	Kearney	Nebraska
United States	Kenton Oncology, Incorporated	Kenton	Ohio
United States	Charles F. Kettering Memorial Hospital	Kettering	Ohio
United States	Cancer Center of Kansas, P.A. - Kingman	Kingman	Kansas
United States	Lenoir Memorial Cancer Center	Kinston	North Carolina
United States	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	Wilford Hall Medical Center	Lackland AFB	Texas
United States	Haematology-Oncology Associates of Ohio and Michigan, P.C.	Lambertville	Michigan
United States	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada
United States	Markey Cancer Center at University of Kentucky Chandler Medical Center	Lexington	Kentucky
United States	Southwest Medical Center	Liberal	Kansas
United States	Lima Memorial Hospital	Lima	Ohio
United States	St. Rita's Medical Center	Lima	Ohio
United States	Meeker County Memorial Hospital	Litchfield	Minnesota
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Valley Memorial Hospital	Livermore	California
United States	Logan Regional Hospital	Logan	Utah
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	UMC Southwest Cancer and Research Center	Lubbock	Texas
United States	MedCentral - Mansfield Hospital	Mansfield	Ohio
United States	St. John's Hospital	Maplewood	Minnesota
United States	Northwest Ohio Oncology Center	Maumee	Ohio
United States	St. Luke's Hospital	Maumee	Ohio
United States	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	Middletown Regional Hospital	Middletown	Ohio
United States	Eastern Montana Cancer Center	Miles City	Montana
United States	Providence Milwaukie Hospital	Milwaukie	Oregon
United States	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota
United States	Virginia Piper Cancer Institute at Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Community Medical Center	Missoula	Montana
United States	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana
United States	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana
United States	Alegent Health Community Memorial Hospital	Missouri Valley	Iowa
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	Trinity Medical Center - East	Moline	Illinois
United States	Community Cancer Center of Monroe	Monroe	Michigan
United States	Mercy Memorial Hospital System	Monroe	Michigan
United States	Ted B. Wahby Cancer Center at Mount Clemens General Hospital	Mount Clemens	Michigan
United States	Good Samaritan Regional Health Center	Mt. Vernon	Illinois
United States	Skagit Valley Hospital Cancer Care Center	Mt. Vernon	Washington
United States	Cottonwood Hospital Medical Center	Murray	Utah
United States	Hackley Hospital	Muskegon	Michigan
United States	Edward Hospital Cancer Center	Naperville	Illinois
United States	Hematology Oncology Consultants Ltd.	Naperville	Illinois
United States	MBCCOP - Meharry Medical College - Nashville	Nashville	Tennessee
United States	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana
United States	Medical Center of Louisiana - New Orleans	New Orleans	Louisiana
United States	St. Vincent's Comprehensive Cancer Center - Manhattan	New York	New York
United States	Cancer Center of Kansas, P.A. - Newton	Newton	Kansas
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Highland General Hospital at St. George's University School of Medicine	Oakland	California
United States	Summit Medical Center	Oakland	California
United States	McKay-Dee Hospital Center	Ogden	Utah
United States	Capital Medical Center	Olympia	Washington
United States	Providence St. Peter Hospital Regional Cancer Center	Olympia	Washington
United States	Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields	Olympia Fields	Illinois
United States	Bergan Mercy Medical Center	Omaha	Nebraska
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Immanuel Medical Center	Omaha	Nebraska
United States	Burgess Health Center	Onawa	Iowa
United States	St. Charles Mercy Hospital	Oregon	Ohio
United States	Toledo Clinic - Oregon	Oregon	Ohio
United States	Comprehensive Cancer Center at Desert Regional Medical Center	Palm Springs	California
United States	Midlands Cancer Center at Midlands Community Hospital	Papillion	Nebraska
United States	Cancer Center of Kansas, P.A. - Parsons	Parsons	Kansas
United States	Northern Michigan Hospital	Petoskey	Michigan
United States	Olympic Medical Center	Port Angeles	Washington
United States	Cancer Institute at Oregon Health and Science University	Portland	Oregon
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	Institute of Oncology at Vilnius University	Portland	Oregon
United States	Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center	Portland	Oregon
United States	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Cancer Center of Kansas, P.A. - Pratt	Pratt	Kansas
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	Good Samaritan Cancer Center	Puyallup	Washington
United States	Commonwealth Hematology-Oncology P. C. - Quincy	Quincy	Massachusetts
United States	All Saints Cancer Center at All Saints Healthcare	Racine	Wisconsin
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Valley Medical Center	Renton	Washington
United States	Hubert H. Humphrey Cancer Center at North Memorial Medical Center	Robbinsdale	Minnesota
United States	Highland Hospital of Rochester	Rochester	New York
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Swedish American Hospital	Rockford	Illinois
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Regions Hospital Cancer Care Center	Saint Paul	Minnesota
United States	Salem Hospital Regional Cancer Center	Salem	Oregon
United States	Cancer Center of Kansas, P.A. - Salina	Salina	Kansas
United States	Salina Regional Health Center	Salina	Kansas
United States	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah
United States	LDS Hospital	Salt Lake City	Utah
United States	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah
United States	Cancer Therapy and Research Center	San Antonio	Texas
United States	University Hospital - San Antonio	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas
United States	J.C. Robinson, M.D. Regional Cancer Center	San Pablo	California
United States	Firelands Regional Medical Center	Sandusky	Ohio
United States	North Coast Cancer Care, Incorporated	Sandusky	Ohio
United States	New Mexico Cancer Care Associates	Santa Fe	New Mexico
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona
United States	CCOP - Virginia Mason Research Center	Seattle	Washington
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Group Health Central Hospital	Seattle	Washington
United States	Harborview Medical Center	Seattle	Washington
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington
United States	North Puget Oncology at United General Hospital	Sedro-Wooley	Washington
United States	Saint Francis Cancer Center	Shakopee	Minnesota
United States	Welch Cancer Center	Sheridan	Wyoming
United States	Cancer Treatment Center at Christus Schumpert St. Mary Place	Shreveport	Louisiana
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center	Sioux City	Iowa
United States	Siouxland Regional Cancer Center	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	Providence Cancer Institute at Providence Hospital - Southfield Campus	Southfield	Michigan
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Cancer Care Northwest - Spokane South	Spokane	Washington
United States	Highlands Oncology Group - Springdale	Springdale	Arkansas
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	St. John's Regional Health Center	Springfield	Missouri
United States	St. Joseph's Hospital	St Paul	Minnesota
United States	Dixie Regional Medical Center	St. George	Utah
United States	CCOP - St. Louis-Cape Girardeau	St. Louis	Missouri
United States	David C. Pratt Cancer Center at St. John's Mercy	St. Louis	Missouri
United States	Missouri Baptist Cancer Center	St. Louis	Missouri
United States	Park Nicollet Health Services	St. Louis Park	Minnesota
United States	United Hospital	St. Paul	Minnesota
United States	Promedica Cancer Center at Flower Hospital	Sylvania	Ohio
United States	Allenmore Hospital	Tacoma	Washington
United States	CCOP - Northwest	Tacoma	Washington
United States	Madigan Army Medical Center	Tacoma	Washington
United States	St. Clare Hospital	Tacoma	Washington
United States	St. Joseph Medical Center at Franciscan Health System	Tacoma	Washington
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	Mercy Hospital of Tiffin	Tiffin	Ohio
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	Medical College of Ohio Cancer Institute	Toledo	Ohio
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio
United States	Toledo Hospital	Toledo	Ohio
United States	Toledo Surgical Specialists	Toledo	Ohio
United States	St. Francis Comprehensive Cancer Center	Topeka	Kansas
United States	Stormont-Vail Cancer Center	Topeka	Kansas
United States	Munson Medical Center	Traverse City	Michigan
United States	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio
United States	Legacy Meridian Park Hospital	Tualatin	Oregon
United States	Natalie Warren Bryant Cancer Center at St. Francis Hospital	Tulsa	Oklahoma
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Southwest Washington Medical Center Cancer Center	Vancouver	Washington
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	Fulton County Health Center	Wauseon	Ohio
United States	Cancer Center of Kansas, P.A. - Wellington	Wellington	Kansas
United States	Central Washington Hospital	Wenatchee	Washington
United States	Wenatchee Valley Clinic	Wenatchee	Washington
United States	Medical Oncology and Hematology Associates - West Des Moines	West Des Moines	Iowa
United States	Jennersville Regional Hospital	West Grove	Pennsylvania
United States	Associates in Womens Health, P.A. - North Review	Wichita	Kansas
United States	Cancer Center of Kansas, P.A. - Medical Arts Tower	Wichita	Kansas
United States	Cancer Center of Kansas, P.A. - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Cancer Center of Kansas, P.A. - Winfield	Winfield	Kansas
United States	Forsyth Regional Cancer Center at Forsyth Medical Center	Winston-Salem	North Carolina
United States	Woodwinds Hospital	Woodbury	Minnesota
United States	United States Air Force Medical Center Wright-Patterson	Wright-Patterson Afb	Ohio
United States	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio
United States	North Star Lodge Cancer Center	Yakima	Washington
United States	Washington Hematology - Oncology Specialists	Yakima	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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-stimul — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of microscopic pathologic response rates		no sooner than 21 days after chemo	No
Primary	Toxicity		during chemo and at surgery	Yes
Primary	Comparison of delivered dose intensity		after chemo	No
Primary	Correlation of microscopic pathologic complete response with clinical complete response at the primary tumor site		no sooner than 21 days after chemo	No