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Surgery to Remove the Sentinel Lymph Node and Axillary Lymph Nodes After Chemotherapy in Treating Women With Stage II, Stage IIIA, or Stage IIIB Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00881361
First received: April 14, 2009
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying surgery to remove the sentinel lymph node and axillary lymph nodes after chemotherapy in treating women with stage II, stage IIIA, or stage IIIB breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: systemic chemotherapy
Procedure: axillary lymph node dissection
Procedure: neoadjuvant therapy
Procedure: sentinel lymph node biopsy
Procedure: therapeutic conventional surgery
Procedure: ultrasound imaging
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Phase II Study Evaluating the Role of Sentinel Lymph Node Surgery and Axillary Lymph Node Dissection Following Preoperative Chemotherapy in Women With Node Positive Breast Cancer (T1-4, N1-2, M0) at Initial Diagnosis

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • False negative rate for SLN surgery, defined as the number of patients with no positive lymph nodes by SLN and with at least one positive lymph node by ALND divided by the total number of patients with at least one positive lymph node by SLN or ALND. [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Axillary ultrasound status after completion of preoperative chemotherapy [ Time Frame: At the time of surgery ] [ Designated as safety issue: No ]
  • Node status after preoperative chemotherapy [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
  • Extent of residual cancer burden [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
  • Relapsed-Free Survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Disease-Free Survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Enrollment: 660
Study Start Date: July 2009
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Study cohort
Patients who plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection.
Drug: systemic chemotherapy Procedure: axillary lymph node dissection Procedure: neoadjuvant therapy Procedure: sentinel lymph node biopsy Procedure: therapeutic conventional surgery Procedure: ultrasound imaging

Detailed Description:

This is a multicenter study. Patients who plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes prior to registration to confirm eligibility and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection. The primary and secondary objectives of the study are described below.

Primary Objective:

1. To determine the false negative rate for sentinel lymph node (SLN) surgery. Among the patients who have at least one sentinel lymph node identified and removed, false negative rate is defined as the number of patients declared to have no evidence of cancer in the SLN and are found to have at least one positive lymph node in the ALND divided by the total number of patients with at least one positive axillary lymph node by ALND.

Secondary Objectives:

  1. To determine how the axillary ultrasound status of the patient upon completion of preoperative chemotherapy (evidence of residual lymphadenopathy on the ultrasound examination versus no evidence of lymphadenopathy in the ultrasound examination) affects the false negative rate of SLN and how sonographic findings correlate with residual disease on final pathology.
  2. To determine the node status of patients after preoperative chemotherapy. Patients will be classified as node positive if they were determined to have at least one positive lymph node by SLN or ALND. Patients will be classified as node negative if all nodes examined by SLN and ALND were negative.
  3. To determine whether the false-negative rate for SLN surgery after preoperative chemotherapy is related to the extent of residual cancer burden (RCB) overall, or separately in the breast or regional nodal basin.
  4. To evaluate pathological complete response (pCR) rates (defined as no invasive disease in breast or lymph nodes) and disease-free survival (DFS) rates in node-positive patients receiving preoperative chemotherapy.

After completion of surgery, patients will visit the office for follow-up exams at 1-2 weeks then patients are followed every 6 months for 2 years, yearly for 2 years, then every other year for 6 years. The study closed to accrual and treatment on 5/29/12.

  Eligibility

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

Eligibility Criteria:

  1. ≥ 18 years old
  2. ECOG/Zubrod Performance Status 0-1
  3. Female. Note: Men are excluded from this study because the number of men with breast cancer is insufficient to provide a statistical basis for assessment of effects in this subpopulation of people with breast cancer.
  4. Histologic diagnosis of invasive breast cancer, clinical stage T0-4 N1-2 M0 (excluding inflammatory breast cancer).
  5. FNA biopsy or core needle biopsy of an axillary node documenting nodal disease at time of diagnosis and prior to preoperative chemotherapy.
  6. Preoperative chemotherapy must be completed or planned for patient. NOTE: Patients enrolling on studies involving preoperative chemotherapy (through cooperative groups or institutional studies) may be eligible for this study, provided sentinel node surgery prior to preoperative chemotherapy was not required in the other studies.
  7. No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or treatment of hidradenitis.
  8. No prior SLN surgery/excisional lymph node biopsy for pathological confirmation of axillary status.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881361

  Hide Study Locations
Locations
United States, Alabama
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States, 36688
United States, Alaska
Providence Cancer Center
Anchorage, Alaska, United States, 99508
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546
Valley Medical Oncology Consultants - Castro Valley
Castro Valley, California, United States, 94546
Cancer Care Center at John Muir Health - Concord Campus
Concord, California, United States, 94524-4110
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Valley Medical Oncology
Fremont, California, United States, 94538
Todd Cancer Institute at Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
Contra Costa Regional Medical Center
Martinez, California, United States, 94553-3156
Community Hospital of the Monterey Peninsula Comprehensive Cancer Center
Monterey, California, United States, 93940
El Camino Hospital Cancer Center
Mountain View, California, United States, 94040
Camino Medical Group - Treatment Center
Mountain View, California, United States, 94040
Bay Area Breast Surgeons, Incorporated
Oakland, California, United States, 94609
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609
Highland General Hospital
Oakland, California, United States, 94602
Larry G Strieff MD Medical Corporation
Oakland, California, United States, 94609
Tom K Lee, Incorporated
Oakland, California, United States, 94609
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
Palo Alto Medical Foundation
Palo Alto, California, United States, 94301
Sharp Memorial Hospital Cancer Center
San Diego, California, United States, 92123
Doctors Medical Center - San Pablo Campus
San Pablo, California, United States, 94806
Stanford Cancer Center
Stanford, California, United States, 94305-5824
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek, California, United States, 94598
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Connecticut
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Washington Cancer Institute at Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Morton Plant Hospital
Clearwater, Florida, United States, 33756
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States, 33458
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Robert and Carol Weissman Cancer Center at Martin Memorial
Stuart, Florida, United States, 34994
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Northside Hospital Cancer Center
Atlanta, Georgia, United States, 30342-1611
WellStar Cobb Hospital
Austell, Georgia, United States, 30106
John B. Amos Cancer Center
Columbus, Georgia, United States, 31904
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, United States, 30033
Piedmont Fayette Hospital
Fayetteville, Georgia, United States, 30214
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Gwinnett Medical Center
Lawrenceville, Georgia, United States, 30045
Medical Center of Central Georgia
Macon, Georgia, United States, 31208
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
Southern Regional Medical Center
Riverdale, Georgia, United States, 30274-2600
Harbin Clinic Cancer Center - Medical Oncology
Rome, Georgia, United States, 30165
United States, Illinois
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States, 62002
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare - Bloomington
Bloomington%, Illinois, United States, 61701
Illinois CancerCare - Canton
Canton, Illinois, United States, 61520
Graham Hospital
Canton, Illinois, United States, 61520
Illinois CancerCare - Carthage
Carthage, Illinois, United States, 62321
Memorial Hospital
Carthage, Illinois, United States, 62321
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612-3785
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Illinois CancerCare - Eureka
Eureka, Illinois, United States, 61530
Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Galesburg Clinic, PC
Galesburg, Illinois, United States, 61401
Illinois CancerCare - Galesburg
Galesburg, Illinois, United States, 61401
Illinois CancerCare - Havana
Havana, Illinois, United States, 62644
Mason District Hospital
Havana, Illinois, United States, 62644
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois, United States, 61443
Illinois CancerCare - Macomb
Macomb, Illinois, United States, 61455
McDonough District Hospital
Macomb, Illinois, United States, 61455
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Illinois CancerCare - Monmouth
Monmouth, Illinois, United States, 61462
OSF Holy Family Medical Center
Monmouth, Illinois, United States, 61462
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States, 62864
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center
Normal, Illinois, United States, 61761
Illinois CancerCare - Community Cancer Center
Normal, Illinois, United States, 61761
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States, 61350
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Illinois CancerCare - Pekin
Pekin, Illinois, United States, 61603
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
Illinois CancerCare - Peru
Peru, Illinois, United States, 61354
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Illinois CancerCare - Princeton
Princeton, Illinois, United States, 61356
Illinois CancerCare - Spring Valley
Spring Valley, Illinois, United States, 61362
United States, Indiana
Clarian West Medical Center
Avon, Indiana, United States, 46123
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
Clarian North Medical Center
Carmel, Indiana, United States, 46032
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Elkhart Clinic, LLC
Elkhart, Indiana, United States, 46514-2098
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289
William N. Wishard Memorial Hospital
Indianapolis, Indiana, United States, 46202
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States, 46545-1470
Reid Hospital & Health Care Services
Richmond, Indiana, United States, 47374
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology-Oncology, PC - South Bend
South Bend, Indiana, United States, 46601
United States, Iowa
Medical Oncology and Hematology Associates - West Des Moines
Clive, Iowa, United States, 50325
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
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
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, United States, 67905
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Saint Luke's Hospital - South
Overland Park, Kansas, United States, 66213
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
CCOP - Kansas City
Prairie Village, Kansas, United States, 66208
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
CCOP - Wichita
Wichita, Kansas, United States, 67214
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Kentucky
St. Elizabeth Medical Center
Edgewood, Kentucky, United States, 41017
Central Baptist Hospital
Lexington, Kentucky, United States, 40503-9985
United States, Maine
Maine Medical Center - Bramhall Campus
Portland, Maine, United States, 04102
United States, Maryland
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
Holy Cross Hospital
Silver Spring, Maryland, United States, 20910
Cancer Institute at St. Joseph Medical Center
Towson, Maryland, United States, 21204
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
Mecosta County Medical Center
Big Rapids, Michigan, United States, 49307
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Dickinson County Healthcare System
Iron Mountain, Michigan, United States, 49801
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, United States, 48144
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States, 48162
Mercy General Health Partners
Muskegon, Michigan, United States, 49443
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States, 49085
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
Metro Health Hospital
Wyoming, Michigan, United States, 49519
United States, Minnesota
Alexandria, Minnesota, United States, 56308
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States, 56303
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
United States, Missouri
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Saint Luke's Hospital
Chesterfield, Missouri, United States, 63017
St. John's Regional Medical Center
Joplin, Missouri, United States, 64804
Truman Medical Center - Hospital Hill
Kansas City, Missouri, United States, 64108
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
St. Joseph Medical Center
Kansas City, Missouri, United States, 64114
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Liberty Hospital
Liberty, Missouri, United States, 64068
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis, Missouri, United States, 63141
Midwest Hematology Oncology Group, Incorporated
Saint Louis, Missouri, United States, 63109
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59102
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States, 59101
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
St. James Healthcare Cancer Care
Butte, Montana, United States, 59701
Great Falls Clinic - Main Facility
Great Falls, Montana, United States, 59405
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
Northern Montana Hospital
Havre, Montana, United States, 59501
St. Peter's Hospital
Helena, Montana, United States, 59601
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States, 59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
Valley Hospital - Ridgewood
Ridgewood, New Jersey, United States, 07450
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Lovelace Women's Hospital
Albuquerque, New Mexico, United States, 87109
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
Albuquerque, New Mexico, United States, 87110
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Beth Israel Medical Center - Petrie Division
New York, New York, United States, 10003-3803
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
St. Luke's - Roosevelt Hospital Center - St.Luke's Division
New York, New York, United States, 10025
Saint Francis Hospital Cancer Center
Poughkeepsie, New York, United States, 12601
Dyson Center for Cancer Care at Vassar Brothers Medical Center
Poughkeepsie, New York, United States, 12601-3990
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
Mary Rutan Hospital
Bellefontaine, Ohio, United States, 43311
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242
Good Samaritan Hospital Cancer Treatment Center
Cincinnati, Ohio, United States, 45220
North Coast Cancer Care - Clyde
Clyde, Ohio, United States, 43410
CCOP - Columbus
Columbus, Ohio, United States, 43215
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Community Cancer Center
Elyria, Ohio, United States, 44035
Hematology Oncology Center
Elyria, Ohio, United States, 44035
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537-1839
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Fisher-Titus Medical Center
Norwalk, Ohio, United States, 44857
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
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
St. Anne Mercy Hospital
Toledo, Ohio, United States, 43623
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43617
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
Clinton Memorial Hospital
Wilmington, Ohio, United States, 45177
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
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Willamette Falls Hospital
Oregon City, Oregon, United States, 97045
Adventist Medical Center
Portland, Oregon, United States, 97216
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States, 18105
Sacred Heart Hospital
Allentown, Pennsylvania, United States, 18102
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem, Pennsylvania, United States, 18015
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, United States, 18201
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center
Upland, Pennsylvania, United States, 19013
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, United States, 17405
United States, Rhode Island
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Hilton Head Regional Medical Center
Hilton Head Island, South Carolina, United States, 29926
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Lexington Medical Center
West Columbia, South Carolina, United States, 29169
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Baptist Hospital
Nashville, Tennessee, United States, 37236
MBCCOP - Meharry Medical College - Nashville
Nashville, Tennessee, United States, 37208-3599
Nashville Breast Center
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Tech University Health Sciences Center School of Medicine - Amarillo
Amarillo, Texas, United States, 79106
Baylor University Medical Center - Dallas
Dallas, Texas, United States, 75246
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Doctor's Hospital of Laredo
Laredo, Texas, United States, 78041
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
United States, Utah
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
United States, Virginia
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States, 22401
Surgical Oncology Associates
Newport News, Virginia, United States, 23606
Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, Washington
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, United States, 99204
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States, 98668
United States, West Virginia
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States, 26102
United States, Wisconsin
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54301-3526
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Vince Lombardi Cancer Clinic - Marinette
Marinette, Wisconsin, United States, 54143
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States, 53201-0342
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States, 54904
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States, 53188
Aurora Women's Pavilion of West Allis Memorial Hospital
West Allis, Wisconsin, United States, 53227
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Judy Boughey, MD Mayo Clinic
  More Information

Additional Information:
No publications provided by Alliance for Clinical Trials in Oncology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00881361     History of Changes
Other Study ID Numbers: CDR0000640100, ACOSOG-Z1071
Study First Received: April 14, 2009
Last Updated: September 24, 2013
Health Authority: United States: Food and Drug Administration
United States: NCI Central Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014