AzTrials
AzTrials

Breast CancerPhase 2NCT00881361

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 2 study testing systemic chemotherapy, axillary lymph node dissection and neoadjuvant therapy in people with Breast Cancer, run by Alliance for Clinical Trials in Oncology at 324 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
systemic chemotherapy, axillary lymph node dissection and neoadjuvant therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
756 participants
Where
324 sitesUnited States
Study dates
Jul 2009to 15 Apr 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

324 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Lovelace Women's Hospital

    Albuquerque, New Mexico, 87109

  • Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital

    Albuquerque, New Mexico, 87110

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131-5636

  • Study site

    Alexandria, Minnesota, 56308

  • Sacred Heart Hospital

    Allentown, Pennsylvania, 18102

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, 62002

  • Texas Tech University Health Sciences Center School of Medicine - Amarillo

    Amarillo, Texas, 79106

  • Providence Cancer Center

    Anchorage, Alaska, 99508

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • DeCesaris Cancer Institute at Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Northside Hospital Cancer Center

    Atlanta, Georgia, 30342-1611

  • University of Colorado Cancer Center at UC Health Sciences Center

    Aurora, Colorado, 80045

  • WellStar Cobb Hospital

    Austell, Georgia, 30106

  • Clarian West Medical Center

    Avon, Indiana, 46123

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • Mary Rutan Hospital

    Bellefontaine, Ohio, 43311

  • St. Luke's Cancer Network at St. Luke's Hospital

    Bethlehem, Pennsylvania, 18015

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59102

  • Illinois CancerCare - Bloomington

    Bloomington, Illinois, 61701

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Graham Hospital

    Canton, Illinois, 61520

  • Illinois CancerCare - Canton

    Canton, Illinois, 61520

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Clarian North Medical Center

    Carmel, Indiana, 46032

  • Illinois CancerCare - Carthage

    Carthage, Illinois, 62321

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants - Castro Valley

    Castro Valley, California, 94546

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • John H. Stroger, Jr. Hospital of Cook County

    Chicago, Illinois, 60612-3785

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Good Samaritan Hospital Cancer Treatment Center

    Cincinnati, Ohio, 45220

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Medical Oncology and Hematology Associates - West Des Moines

    Clive, Iowa, 50325

  • North Coast Cancer Care - Clyde

    Clyde, Ohio, 43410

  • John B. Amos Cancer Center

    Columbus, Georgia, 31904

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Medical Center Cancer Care

    Columbus, Ohio, 43215

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Cancer Care Center at John Muir Health - Concord Campus

    Concord, California, 94524-4110

  • Baylor University Medical Center - Dallas

    Dallas, Texas, 75246

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • Charles B. Eberhart Cancer Center at DeKalb Medical Center

    Decatur, Georgia, 30033

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa, 50314

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • St. Elizabeth Medical Center

    Edgewood, Kentucky, 41017

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Elkhart Clinic, LLC

    Elkhart, Indiana, 46514-2098

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Community Cancer Center

    Elyria, Ohio, 44035

  • Hematology Oncology Center

    Elyria, Ohio, 44035

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • Illinois CancerCare - Eureka

    Eureka, Illinois, 61530

  • Evanston Hospital

    Evanston, Illinois, 60201-1781

  • Piedmont Fayette Hospital

    Fayetteville, Georgia, 30214

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Fredericksburg Oncology, Incorporated

    Fredericksburg, Virginia, 22401

  • Valley Medical Oncology

    Fremont, California, 94538

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Galesburg Clinic, PC

    Galesburg, Illinois, 61401

  • Illinois CancerCare - Galesburg

    Galesburg, Illinois, 61401

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54301-3526

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Illinois CancerCare - Havana

    Havana, Illinois, 62644

  • Mason District Hospital

    Havana, Illinois, 62644

  • Northern Montana Hospital

    Havre, Montana, 59501

  • Geisinger Hazleton Cancer Center

    Hazleton, Pennsylvania, 18201

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Hilton Head Regional Medical Center

    Hilton Head Island, South Carolina, 29926

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202-5289

  • William N. Wishard Memorial Hospital

    Indianapolis, Indiana, 46202

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • Dickinson County Healthcare System

    Iron Mountain, Michigan, 49801

  • St. John's Regional Medical Center

    Joplin, Missouri, 64804

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Truman Medical Center - Hospital Hill

    Kansas City, Missouri, 64108

  • Saint Luke's Cancer Institute at Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • St. Joseph Medical Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Illinois CancerCare - Kewanee Clinic

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • Gundersen Lutheran Center for Cancer and Blood

    La Crosse, Wisconsin, 54601

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Haematology-Oncology Associates of Ohio and Michigan, PC

    Lambertville, Michigan, 48144

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17604

  • Doctor's Hospital of Laredo

    Laredo, Texas, 78041

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Gwinnett Medical Center

    Lawrenceville, Georgia, 30045

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Central Baptist Hospital

    Lexington, Kentucky, 40503-9985

  • Cancer Center of Kansas, PA - Liberal

    Liberal, Kansas, 67905

  • Liberty Hospital

    Liberty, Missouri, 64068

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Todd Cancer Institute at Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410-1894

  • Illinois CancerCare - Macomb

    Macomb, Illinois, 61455

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • Medical Center of Central Georgia

    Macon, Georgia, 31208

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Kennestone Cancer Center at Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Vince Lombardi Cancer Clinic - Marinette

    Marinette, Wisconsin, 54143

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

    Marlton, New Jersey, 08053

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537-1839

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • University of Miami Sylvester Comprehensive Cancer Center - Miami

    Miami, Florida, 33136

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53201-0342

  • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Saint Joseph Regional Medical Center

    Mishawaka, Indiana, 46545-1470

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36688

  • Illinois CancerCare - Monmouth

    Monmouth, Illinois, 61462

  • OSF Holy Family Medical Center

    Monmouth, Illinois, 61462

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital - Monroe

    Monroe, Michigan, 48162

  • Community Hospital of the Monterey Peninsula Comprehensive Cancer Center

    Monterey, California, 93940

  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals

    Morgantown, West Virginia, 26506

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • Camino Medical Group - Treatment Center

    Mountain View, California, 94040

  • El Camino Hospital Cancer Center

    Mountain View, California, 94040

  • Mercy General Health Partners

    Muskegon, Michigan, 49443

  • Nashville Breast Center

    Nashville, Tennessee, 37203

  • MBCCOP - Meharry Medical College - Nashville

    Nashville, Tennessee, 37208-3599

  • Baptist Hospital

    Nashville, Tennessee, 37236

  • Beth Israel Medical Center - Petrie Division

    New York, New York, 10003-3803

  • St. Luke's - Roosevelt Hospital Center - St.Luke's Division

    New York, New York, 10025

  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

    New York, New York, 10032

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

  • Surgical Oncology Associates

    Newport News, Virginia, 23606

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Sentara Cancer Institute at Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • Illinois CancerCare - Community Cancer Center

    Normal, Illinois, 61761

  • Fisher-Titus Medical Center

    Norwalk, Ohio, 44857

  • Highland General Hospital

    Oakland, California, 94602

  • Bay Area Breast Surgeons, Incorporated

    Oakland, California, 94609

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Larry G Strieff MD Medical Corporation

    Oakland, California, 94609

  • Tom K Lee, Incorporated

    Oakland, California, 94609

  • Regional Cancer Center at Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • Green Bay Oncology, Limited - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

    Orange, California, 92868

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic - Oregon

    Oregon, Ohio, 43616

  • Willamette Falls Hospital

    Oregon City, Oregon, 97045

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • Oncology Hematology Associates of Central Illinois, PC - Ottawa

    Ottawa, Illinois, 61350

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Saint Luke's Hospital - South

    Overland Park, Kansas, 66213

  • Palo Alto Medical Foundation

    Palo Alto, California, 94301

  • Cancer Center of Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301-1792

  • Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital

    Parkersburg, West Virginia, 26102

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Illinois CancerCare - Pekin

    Pekin, Illinois, 61603

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare - Peru

    Peru, Illinois, 61354

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Allegheny Cancer Center at Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • UPMC Cancer Centers

    Pittsburgh, Pennsylvania, 15232

  • Maine Medical Center - Bramhall Campus

    Portland, Maine, 04102

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • Adventist Medical Center

    Portland, Oregon, 97216

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Dyson Center for Cancer Care at Vassar Brothers Medical Center

    Poughkeepsie, New York, 12601-3990

  • Saint Francis Hospital Cancer Center

    Poughkeepsie, New York, 12601

  • CCOP - Kansas City

    Prairie Village, Kansas, 66208

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Illinois CancerCare - Princeton

    Princeton, Illinois, 61356

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Women and Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

  • Reid Hospital & Health Care Services

    Richmond, Indiana, 47374

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Valley Hospital - Ridgewood

    Ridgewood, New Jersey, 07450

  • Southern Regional Medical Center

    Riverdale, Georgia, 30274-2600

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Harbin Clinic Cancer Center - Medical Oncology

    Rome, Georgia, 30165

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • CentraCare Clinic - River Campus

    Saint Cloud, Minnesota, 56303

  • Coborn Cancer Center

    Saint Cloud, Minnesota, 56303

  • Lakeland Regional Cancer Care Center - St. Joseph

    Saint Joseph, Michigan, 49085

  • Lakeside Cancer Specialists, PLLC

    Saint Joseph, Michigan, 49085

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67401

  • Peninsula Regional Medical Center

    Salisbury, Maryland, 21801

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112

  • Sharp Memorial Hospital Cancer Center

    San Diego, California, 92123

  • Doctors Medical Center - San Pablo Campus

    San Pablo, California, 94806

  • North Coast Cancer Care, Incorporated

    Sandusky, Ohio, 44870

  • Holy Cross Hospital

    Silver Spring, Maryland, 20910

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51104

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Michiana Hematology-Oncology, PC - South Bend

    South Bend, Indiana, 46601

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Providence Cancer Center at Sacred Heart Medical Center

    Spokane, Washington, 99204

  • Illinois CancerCare - Spring Valley

    Spring Valley, Illinois, 61362

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

  • Midwest Hematology Oncology Group, Incorporated

    St Louis, Missouri, 63109

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • David C. Pratt Cancer Center at St. John's Mercy

    St Louis, Missouri, 63141

  • Stanford Cancer Center

    Stanford, California, 94305-5824

  • Geisinger Medical Group - Scenery Park

    State College, Pennsylvania, 16801

  • Robert and Carol Weissman Cancer Center at Martin Memorial

    Stuart, Florida, 34994

  • Green Bay Oncology, Limited - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • Albert Einstein Cancer Center at Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • Medical University of Ohio Cancer Center

    Toledo, Ohio, 43614

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43617

  • St. Anne Mercy Hospital

    Toledo, Ohio, 43623

  • Cancer Institute at St. Joseph Medical Center

    Towson, Maryland, 21204

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373-1300

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center

    Upland, Pennsylvania, 19013

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Being tested
systemic chemotherapy, axillary lymph node dissection, neoadjuvant therapy, sentinel lymph node biopsy, therapeutic conventional surgery
Keywords
stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • systemic chemotherapyDrug

  • axillary lymph node dissectionProcedure or surgery

  • neoadjuvant therapyProcedure or surgery

  • sentinel lymph node biopsyProcedure or surgery

  • therapeutic conventional surgeryProcedure or surgery

  • ultrasound imagingProcedure or surgery

Study groups in NCT00881361
Study groupRoleWhat they receive
Study cohortOtherPatients 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.
Receives: Drug: systemic chemotherapy; Procedure: axillary lymph node dissection; Procedure: neoadjuvant therapy; Procedure: sentinel lymph node biopsy; Procedure: therapeutic conventional surgery; Procedure: ultrasound imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At time of surgery

Secondary outcomes (5)

  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 cN2 Breast Cancer [cN2 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 cN2 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. An interval estimate of the SLN false negative rate will be constructed using the Duffy-Santner approach.

    Measured: At time of surgery

  2. False-negative Rate (FNR) Under the Selection Process by Axillary Ultrasound (AUS) Status After Completion of Neoadjuvant Chemotherapy (NAC)

    False negative rate (FNR) (percentage) for sentinel lymph node (SLN) surgery after chemotherapy in women with normal AUS and at least 2 SLNs were excised, 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 with at least one positive lymph node by SLN or ALND multiplied by 100.

    Measured: At the time of surgery

  3. Node Status After Preoperative Chemotherapy, as Measured by the Total Number of Positive Nodes (SLN+ALND)

    Node status of patients after preoperative chemotherapy, as measured by the total number of positive nodes (SLN+ALND). Patients will be classified as node positive if they were determined to have at least one positive lymph node by SLN or ALND.

    Measured: At time of surgery

  4. Pathologic Complete Nodal Response (pCR) Rate

    Pathologic complete nodal response (pCR) rate (percentage) wherein a nodal pCR is pathologically node-negative (pN0) on the basis of SLN surgery and ALND. A 95% binomial confidence interval was constructed for the pCR rate.

    Measured: At the time of surgery

  5. Residual Cancer Burden Class

    Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. The calculated RCB index value can also be categorized as one of four RCB classes. The number of patients classified in the four RCB classes along with the number of patients missing this data by cohort are reported below. RCB of 0 represents a path complete response while increasing levels (I, then II, then III) indicate an increase in the 'amount' of residual disease remaining.

    Measured: At time of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionNov 2012
  4. Study completion15 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
756 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00881361
Sponsor's protocol ID
ACOSOG-Z1071
Other IDs
ACOSOG-Z1071, CDR0000640100
Status last verified
Apr 2023
First submitted
14 Apr 2009
Last updated
27 Apr 2023
Data monitoring committee
Yes

Publications

  • 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.

  • Boughey 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.

    PubMed 24101169

  • Boughey 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.

    PubMed 25646192

  • Armer 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.

    PubMed 29980907

  • Boughey 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.

    PubMed 28657941

  • Boughey 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.

    PubMed 25664534

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing systemic chemotherapy, axillary lymph node dissection and neoadjuvant therapy in people with Breast Cancer, run by Alliance for Clinical Trials in Oncology at 324 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 324 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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] (time frame: At time of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00881361, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT00881361 | AzTrials