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
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
2 other identifiers
interventional
756
1 country
324
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Jul 2009
Longer than P75 for phase_2 breast-cancer
324 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2009
CompletedFirst Posted
Study publicly available on registry
April 15, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedResults Posted
Study results publicly available
December 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2023
CompletedApril 27, 2023
April 1, 2023
3.3 years
April 14, 2009
September 19, 2018
April 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
False Negative Rate (FNR) for Sentinel Lymph Node (SLN) Surgery After Chemotherapy When at Least 2 SLNs Were Excised in Women Initially Presenting With Biopsy-proven cN1 Breast Cancer [cN1 Cohort]
False negative rate (FNR) (percentage) for sentinel lymph node (SLN) surgery after chemotherapy when at least 2 SLNs were excised in women initially presenting with biopsy-proven cN1 breast cancer, defined as the number of patients with no positive lymph nodes by SLN and with at least one positive lymph node by axillary lymph node dissection (ALND) divided by the total number of patients initially presenting with biopsy-proven cN1 breast cancer with at least one positive lymph node by SLN or ALND multiplied by 100. A 2-sided Bayesian credible interval (BCI) for the true FNR was constructed.
At time of surgery
Secondary Outcomes (5)
False Negative Rate (FNR) for Sentinel Lymph Node (SLN) Surgery After Chemotherapy When at Least 2 SLNs Were Excised in Women Initially Presenting With Biopsy-proven cN2 Breast Cancer [cN2 Cohort]
At time of surgery
False-negative Rate (FNR) Under the Selection Process by Axillary Ultrasound (AUS) Status After Completion of Neoadjuvant Chemotherapy (NAC)
At the time of surgery
Node Status After Preoperative Chemotherapy, as Measured by the Total Number of Positive Nodes (SLN+ALND)
At time of surgery
Pathologic Complete Nodal Response (pCR) Rate
At the time of surgery
Residual Cancer Burden Class
At time of surgery
Other Outcomes (1)
Disease-Free Survival
Up to 10 years
Study Arms (1)
Study cohort
OTHERPatients 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.
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (324)
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36688, United States
Providence Cancer Center
Anchorage, Alaska, 99508, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
East Bay Radiation Oncology Center
Castro Valley, California, 94546, United States
Valley Medical Oncology Consultants - Castro Valley
Castro Valley, California, 94546, United States
Cancer Care Center at John Muir Health - Concord Campus
Concord, California, 94524-4110, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000, United States
Valley Medical Oncology
Fremont, California, 94538, United States
Todd Cancer Institute at Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90089-9181, United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156, United States
Community Hospital of the Monterey Peninsula Comprehensive Cancer Center
Monterey, California, 93940, United States
Camino Medical Group - Treatment Center
Mountain View, California, 94040, United States
El Camino Hospital Cancer Center
Mountain View, California, 94040, United States
Highland General Hospital
Oakland, California, 94602, United States
Bay Area Breast Surgeons, Incorporated
Oakland, California, 94609, United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609, United States
Larry G Strieff MD Medical Corporation
Oakland, California, 94609, United States
Tom K Lee, Incorporated
Oakland, California, 94609, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, 92868, United States
Palo Alto Medical Foundation
Palo Alto, California, 94301, United States
Sharp Memorial Hospital Cancer Center
San Diego, California, 92123, United States
Doctors Medical Center - San Pablo Campus
San Pablo, California, 94806, United States
Stanford Cancer Center
Stanford, California, 94305-5824, United States
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek, California, 94598, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, 80045, United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Washington Cancer Institute at Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, 33458, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, 33136, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Robert and Carol Weissman Cancer Center at Martin Memorial
Stuart, Florida, 34994, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Northside Hospital Cancer Center
Atlanta, Georgia, 30342-1611, United States
WellStar Cobb Hospital
Austell, Georgia, 30106, United States
John B. Amos Cancer Center
Columbus, Georgia, 31904, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, 30033, United States
Piedmont Fayette Hospital
Fayetteville, Georgia, 30214, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Gwinnett Medical Center
Lawrenceville, Georgia, 30045, United States
Medical Center of Central Georgia
Macon, Georgia, 31208, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, Georgia, 30060, United States
Southern Regional Medical Center
Riverdale, Georgia, 30274-2600, United States
Harbin Clinic Cancer Center - Medical Oncology
Rome, Georgia, 30165, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, 62002, United States
Illinois CancerCare - Bloomington
Bloomington, Illinois, 61701, United States
St. Joseph Medical Center
Bloomington, Illinois, 61701, United States
Graham Hospital
Canton, Illinois, 61520, United States
Illinois CancerCare - Canton
Canton, Illinois, 61520, United States
Illinois CancerCare - Carthage
Carthage, Illinois, 62321, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, 60612-3785, United States
Eureka Community Hospital
Eureka, Illinois, 61530, United States
Illinois CancerCare - Eureka
Eureka, Illinois, 61530, United States
Evanston Hospital
Evanston, Illinois, 60201-1781, United States
Galesburg Clinic, PC
Galesburg, Illinois, 61401, United States
Illinois CancerCare - Galesburg
Galesburg, Illinois, 61401, United States
Illinois CancerCare - Havana
Havana, Illinois, 62644, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois, 61443, United States
Illinois CancerCare - Macomb
Macomb, Illinois, 61455, United States
McDonough District Hospital
Macomb, Illinois, 61455, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, 60153, United States
Illinois CancerCare - Monmouth
Monmouth, Illinois, 61462, United States
OSF Holy Family Medical Center
Monmouth, Illinois, 61462, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, United States
BroMenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center
Normal, Illinois, 61761, United States
Illinois CancerCare - Community Cancer Center
Normal, Illinois, 61761, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, 61554, United States
Illinois CancerCare - Pekin
Pekin, Illinois, 61603, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61615, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare - Peru
Peru, Illinois, 61354, United States
Illinois Valley Community Hospital
Peru, Illinois, 61354, United States
Illinois CancerCare - Princeton
Princeton, Illinois, 61356, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
Illinois CancerCare - Spring Valley
Spring Valley, Illinois, 61362, United States
Clarian West Medical Center
Avon, Indiana, 46123, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, 46107, United States
Clarian North Medical Center
Carmel, Indiana, 46032, United States
Elkhart Clinic, LLC
Elkhart, Indiana, 46514-2098, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202-5289, United States
William N. Wishard Memorial Hospital
Indianapolis, Indiana, 46202, United States
Howard Community Hospital
Kokomo, Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350, United States
Saint Joseph Regional Medical Center
Mishawaka, Indiana, 46545-1470, United States
Reid Hospital & Health Care Services
Richmond, Indiana, 47374, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Michiana Hematology-Oncology, PC - South Bend
South Bend, Indiana, 46601, United States
Medical Oncology and Hematology Associates - West Des Moines
Clive, Iowa, 50325, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1002, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, 66160-7357, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, 67905, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, 67114, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Saint Luke's Hospital - South
Overland Park, Kansas, 66213, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, 67357, United States
CCOP - Kansas City
Prairie Village, Kansas, 66208, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, 67214, United States
CCOP - Wichita
Wichita, Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, 67156, United States
St. Elizabeth Medical Center
Edgewood, Kentucky, 41017, United States
Central Baptist Hospital
Lexington, Kentucky, 40503-9985, United States
Maine Medical Center - Bramhall Campus
Portland, Maine, 04102, United States
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Peninsula Regional Medical Center
Salisbury, Maryland, 21801, United States
Holy Cross Hospital
Silver Spring, Maryland, 20910, United States
Cancer Institute at St. Joseph Medical Center
Towson, Maryland, 21204, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, 49221, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0942, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, 49017, United States
Mecosta County Medical Center
Big Rapids, Michigan, 49307, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, 49431, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, 49503, United States
Dickinson County Healthcare System
Iron Mountain, Michigan, 49801, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, 48144, United States
Community Cancer Center of Monroe
Monroe, Michigan, 48162, United States
Mercy Memorial Hospital - Monroe
Monroe, Michigan, 48162, United States
Mercy General Health Partners
Muskegon, Michigan, 49443, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, 48073, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, 49085, United States
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, 49085, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
Unknown Facility
Alexandria, Minnesota, 56308, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, 56303, United States
Coborn Cancer Center
Saint Cloud, Minnesota, 56303, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Saint Luke's Hospital
Chesterfield, Missouri, 63017, United States
St. John's Regional Medical Center
Joplin, Missouri, 64804, United States
Truman Medical Center - Hospital Hill
Kansas City, Missouri, 64108, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, 64111, United States
St. Joseph Medical Center
Kansas City, Missouri, 64114, United States
North Kansas City Hospital
Kansas City, Missouri, 64116, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, 64086, United States
Liberty Hospital
Liberty, Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65802, United States
St. John's Regional Health Center
Springfield, Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807, United States
Midwest Hematology Oncology Group, Incorporated
St Louis, Missouri, 63109, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, 63141, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings, Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, 59102, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
St. James Healthcare Cancer Care
Butte, Montana, 59701, United States
Great Falls Clinic - Main Facility
Great Falls, Montana, 59405, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, 59405, United States
Northern Montana Hospital
Havre, Montana, 59501, United States
St. Peter's Hospital
Helena, Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology at KRMC
Kalispell, Montana, 59901, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, 59807-7877, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, 59807, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, 08053, United States
Valley Hospital - Ridgewood
Ridgewood, New Jersey, 07450, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees Township, New Jersey, 08043, United States
Lovelace Women's Hospital
Albuquerque, New Mexico, 87109, United States
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131-5636, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001, United States
Beth Israel Medical Center - Petrie Division
New York, New York, 10003-3803, United States
St. Luke's - Roosevelt Hospital Center - St.Luke's Division
New York, New York, 10025, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, 10032, United States
Dyson Center for Cancer Care at Vassar Brothers Medical Center
Poughkeepsie, New York, 12601-3990, United States
Saint Francis Hospital Cancer Center
Poughkeepsie, New York, 12601, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, 28232-2861, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, 28233-3549, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, 44307, United States
Mary Rutan Hospital
Bellefontaine, Ohio, 43311, United States
Wood County Oncology Center
Bowling Green, Ohio, 43402, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Good Samaritan Hospital Cancer Treatment Center
Cincinnati, Ohio, 45220, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
North Coast Cancer Care - Clyde
Clyde, Ohio, 43410, United States
CCOP - Columbus
Columbus, Ohio, 43215, United States
Grant Medical Center Cancer Care
Columbus, Ohio, 43215, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, 43222, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, 43228, United States
Good Samaritan Hospital
Dayton, Ohio, 45406, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Cancer Care Center
Dayton, Ohio, 45415, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Community Cancer Center
Elyria, Ohio, 44035, United States
Hematology Oncology Center
Elyria, Ohio, 44035, United States
Blanchard Valley Medical Associates
Findlay, Ohio, 45840, United States
Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, 45429, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Northwest Ohio Oncology Center
Maumee, Ohio, 43537-1839, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, 43055, United States
Fisher-Titus Medical Center
Norwalk, Ohio, 44857, United States
St. Charles Mercy Hospital
Oregon, Ohio, 43616, United States
Toledo Clinic - Oregon
Oregon, Ohio, 43616, United States
North Coast Cancer Care, Incorporated
Sandusky, Ohio, 44870, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, 45505, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, 43614, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43617, United States
St. Anne Mercy Hospital
Toledo, Ohio, 43623, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, 45373-1300, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, 43081, United States
Clinton Memorial Hospital
Wilmington, Ohio, 45177, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, 74136, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, 97222, United States
Providence Newberg Medical Center
Newberg, Oregon, 97132, United States
Willamette Falls Hospital
Oregon City, Oregon, 97045, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213-2967, United States
Adventist Medical Center
Portland, Oregon, 97216, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Sacred Heart Hospital
Allentown, Pennsylvania, 18102, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, 18105, United States
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem, Pennsylvania, 18015, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, 17822-0001, United States
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, 18201, United States
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17604, United States
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541, United States
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232, United States
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, 16801, United States
Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center
Upland, Pennsylvania, 19013, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, 17405, United States
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Hilton Head Regional Medical Center
Hilton Head Island, South Carolina, 29926, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Lexington Medical Center
West Columbia, South Carolina, 29169, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Nashville Breast Center
Nashville, Tennessee, 37203, United States
MBCCOP - Meharry Medical College - Nashville
Nashville, Tennessee, 37208-3599, United States
Baptist Hospital
Nashville, Tennessee, 37236, United States
Texas Tech University Health Sciences Center School of Medicine - Amarillo
Amarillo, Texas, 79106, United States
Baylor University Medical Center - Dallas
Dallas, Texas, 75246, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009, United States
Doctor's Hospital of Laredo
Laredo, Texas, 78041, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410-1894, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112, United States
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, 22401, United States
Surgical Oncology Associates
Newport News, Virginia, 23606, United States
Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298-0037, United States
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, 99204, United States
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, 98668, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, 26506, United States
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Parkersburg, West Virginia, 26102, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301-3526, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508, United States
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164, United States
Vince Lombardi Cancer Clinic - Marinette
Marinette, Wisconsin, 54143, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53201-0342, United States
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226, United States
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, 53188, United States
Aurora Women's Pavilion of West Allis Memorial Hospital
West Allis, Wisconsin, 53227, United States
Rocky Mountain Oncology
Casper, Wyoming, 82609, United States
Related Publications (6)
Le-Petross HT, McCall LM, Hunt K, et al.: Role of axillary ultrasound after neoadjuvant chemotherapy in women with node-positive breast cancer (T1-4, N1-2, M0) at initial diagnosis (ACOSOG Z1071). [Abstract] J Clin Oncol 30 (Suppl 15): A-1107, 2012.
RESULTBoughey JC, Suman VJ, Mittendorf EA, Ahrendt GM, Wilke LG, Taback B, Leitch AM, Kuerer HM, Bowling M, Flippo-Morton TS, Byrd DR, Ollila DW, Julian TB, McLaughlin SA, McCall L, Symmans WF, Le-Petross HT, Haffty BG, Buchholz TA, Nelson H, Hunt KK; Alliance for Clinical Trials in Oncology. Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer: the ACOSOG Z1071 (Alliance) clinical trial. JAMA. 2013 Oct 9;310(14):1455-61. doi: 10.1001/jama.2013.278932.
PMID: 24101169RESULTBoughey JC, Ballman KV, Hunt KK, McCall LM, Mittendorf EA, Ahrendt GM, Wilke LG, Le-Petross HT. Axillary Ultrasound After Neoadjuvant Chemotherapy and Its Impact on Sentinel Lymph Node Surgery: Results From the American College of Surgeons Oncology Group Z1071 Trial (Alliance). J Clin Oncol. 2015 Oct 20;33(30):3386-93. doi: 10.1200/JCO.2014.57.8401. Epub 2015 Feb 2.
PMID: 25646192RESULTArmer JM, Ballman KV, McCall L, Armer NC, Sun Y, Udmuangpia T, Hunt KK, Mittendorf EA, Byrd DR, Julian TB, Boughey JC. Lymphedema symptoms and limb measurement changes in breast cancer survivors treated with neoadjuvant chemotherapy and axillary dissection: results of American College of Surgeons Oncology Group (ACOSOG) Z1071 (Alliance) substudy. Support Care Cancer. 2019 Feb;27(2):495-503. doi: 10.1007/s00520-018-4334-7. Epub 2018 Jul 6.
PMID: 29980907DERIVEDBoughey JC, Ballman KV, McCall LM, Mittendorf EA, Symmans WF, Julian TB, Byrd D, Hunt KK. Tumor Biology and Response to Chemotherapy Impact Breast Cancer-specific Survival in Node-positive Breast Cancer Patients Treated With Neoadjuvant Chemotherapy: Long-term Follow-up From ACOSOG Z1071 (Alliance). Ann Surg. 2017 Oct;266(4):667-676. doi: 10.1097/SLA.0000000000002373.
PMID: 28657941DERIVEDBoughey JC, Suman VJ, Mittendorf EA, Ahrendt GM, Wilke LG, Taback B, Leitch AM, Flippo-Morton TS, Kuerer HM, Bowling M, Hunt KK; Alliance for Clinical Trials in Oncology. Factors affecting sentinel lymph node identification rate after neoadjuvant chemotherapy for breast cancer patients enrolled in ACOSOG Z1071 (Alliance). Ann Surg. 2015 Mar;261(3):547-52. doi: 10.1097/SLA.0000000000000551.
PMID: 25664534DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Judy C. Boughey, MD
- Organization
- Mayo Clinic
Study Officials
- STUDY CHAIR
Judy Boughey, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2009
First Posted
April 15, 2009
Study Start
July 1, 2009
Primary Completion
November 1, 2012
Study Completion
April 15, 2023
Last Updated
April 27, 2023
Results First Posted
December 5, 2018
Record last verified: 2023-04