AzTrials
AzTrials

Breast CancerPhase 3NCT00003854

Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer

A Phase 3 study testing immunohistochemistry staining method, lymphangiography and sentinel lymph node biopsy in people with Breast Cancer, run by Alliance for Clinical Trials in Oncology at 116 sites in 3 countries.

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: Biopsy of sentinel lymph nodes and bone marrow may improve the ability to detect and determine the extent of cancer. PURPOSE: Phase III prognostic study of sentinel lymph node metastases and bone marrow metastases in women who have stage I or stage IIA breast cancer. 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?
immunohistochemistry staining method, lymphangiography and sentinel lymph node biopsy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,590 participants
Where
116 sitesin 3 countries
Study dates
Apr 1999to Jul 2011
Phase
Phase 3
Are there results?
None posted in the registry

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

Who may be able to join

  • Patient must be female.
  • Patient's clinical stage must be I or II (T1 or T2 N0 M0) and the tumor must be amenable to segmental mastectomy (lumpectomy).
  • Patient must have a tissue diagnosis of invasive breast carcinoma. Note: A patient can be registered to this study if they have a cytologic diagnosis suggestive of carcinoma from a fine needle aspiration (FNA) of a palpable or non-palpable breast lesion and the investigator believes the breast lesion is clinically suspicious for invasive breast carcinoma.
  • The date of the patient's first tissue diagnosis of invasive breast carcinoma or cytologic diagnosis of breast carcinoma must be no more than 60 days prior to SLND.
  • The patient who had segmental mastectomy (lumpectomy) performed previously, and is now referred to the local investigator for SLND, is eligible if the lumpectomy was less than or equal to 60 days prior to the SLND. Copies of the operative and pathology reports must be submitted as a part of the registration process.
  • Patient must have ECOG/Zubrod status of ≤2, as documented in patient's medical record.
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  • Patient must be available for follow-up.
  • The patient with a history of a previous malignancy is eligible for this study as long as the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided that the following criteria are met:
  • The patient has undergone potentially curative therapy for all prior malignancies.
  • There has been no evidence of any prior malignancies for at least five years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone), and
  • The patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
  • Signed and dated informed consent is obtained prior to patient registration.
  • Patients of childbearing potential must have a negative serum or urine pregnancy test within 14 days of beginning study interventions.
  • Patient must be able to physically undergo bilateral anterior iliac crest bone marrow aspiration.

Who cannot join

  • Patient is lactating (breastfeeding).
  • Patient has been previously treated with chemotherapy, estrogen receptor antagonists (i.e. Tamoxifen) or selective estrogen receptor modulators (SERMs, i.e. Raloxifene) for this invasive breast cancer.
  • Patient has a previously placed pre-pectoral breast implant. NOTE: A subpectoral implant is allowed.
  • Patient is considered a poor surgical risk due to a non-malignant systemic disease (cardiovascular, renal, etc.), which would preclude the treatment options.
  • Patient has concurrent bilateral invasive breast malignancies.
  • Patient is not able to undergo and does not have access to radiation therapy as describedin Adjuvant Radiation Therapy in the Interventions section of the protocol.
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  • Patients with active connective tissue disorders and those that live too far from a radiation treatment center, for example, would not be eligible.
  • Patient has clinically and radiologically identified multi-centric disease that is not amenable to a single lumpectomy.
  • Patient has had previous ipsilateral axillary surgery such as excisional biopsy of lymph node(s), treatment of hidradenitis.

Trial locations and contacts

116 sites in 3 countries.

116 sites in 3 countries

United States113 sites

  • Sacred Heart Hospital

    Allentown, Pennsylvania, 18102

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Texas Cancer Center at Brackenridge Hospital

    Austin, Texas, 78701

  • Woman's Hospital

    Baton Rouge, Louisiana, 70815

  • Baton Rouge General Medical Center

    Baton Rouge, Louisiana, 70821-2511

  • St. Elizabeth's Hospital

    Belleville, Illinois, 62220-1998

  • Belleville Memorial Hospital

    Belleville, Illinois, 62226-5399

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • St. Luke's Regional Medical Center

    Boise, Idaho, 83712

  • Lutheran Medical Center

    Brooklyn, New York, 11220

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Lahey Clinic - Burlington

    Burlington, Massachusetts, 01805

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

  • Northwestern University Medical Center

    Chicago, Illinois, 60611

  • Carilion New River Valley Medical Center

    Christiansburg, Virginia, 24073

  • Tri-Health Good Samaritan Hospital

    Cincinnati, Ohio, 90027

  • Morton Plant Mease Health Care

    Clearwater, Florida, 33756

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Memorial Hospital Cancer Center

    Colorado Springs, Colorado, 80909

  • Columbia Regional Hospital

    Columbia, Missouri, 65201

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri, 65203

  • University of Missouri-Columbia Hospital and Clinics

    Columbia, Missouri, 65212

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210-1228

  • Zale Lipshy University Hospital

    Dallas, Texas, 75235-7786

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • St. Paul University Hospital

    Dallas, Texas, 75235

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • DeKalb Medical Center, Inc.

    Decatur, Georgia, 30033

  • University of Colorado Cancer Center

    Denver, Colorado, 80010

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Durham Regional Hospital

    Durham, North Carolina, 27704-2763

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • Evanston Northwestern Health Care

    Evanston, Illinois, 60201

  • Little Company of Mary Hospital - Evergreen Park

    Evergreen Park, Illinois, 60805-2746

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042-3300

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030-3955

  • Washington Regional Medical Center

    Fayetteville, Arkansas, 72703

  • Cape Fear Valley Health System

    Fayetteville, North Carolina, 28302-2000

  • McLaren Regional Cancer Center

    Flint, Michigan, 48432

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0542

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439-8066

  • Spectrum Health - Butterworth Campus

    Grand Rapids, Michigan, 49546

  • St. Francis Medical Center

    Honolulu, Hawaii, 96817

  • Kaiser Permanente Medical Center

    Honolulu, Hawaii, 96819

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Ben Taub General Hospital

    Houston, Texas, 77030

  • Methodist Hospital

    Houston, Texas, 77030

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Keesler Medical Center - Keesler AFB

    Keesler Air Force Base, Mississippi, 39534-2576

  • Kingston Hospital

    Kingston, New York, 12401-4692

  • Benedictine Hospital

    Kingston, New York, 12401

  • Lakeland Regional Medical Center

    Lakeland, Florida, 33804

  • Watson Clinic

    Lakeland, Florida, 33805

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756-0002

  • Central Baptist Hospital

    Lexington, Kentucky, 40503-9985

  • St. Vincent Doctors Doctors Hospital

    Little Rock, Arkansas, 72205-5331

  • Baptist Health Medical Center

    Little Rock, Arkansas, 72205-7200

  • Kaiser Permanente Medical Center - Los Angeles

    Los Angeles, California, 90027

  • Norton Healthcare System

    Louisville, Kentucky, 40202-5070

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410-1894

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Saint Anthony Memorial Health Center - Michigan City Campus

    Michigan City, Indiana, 46360

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53201-0342

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215-5166

  • Froedtert Memorial Lutheran Hospital

    Milwaukee, Wisconsin, 53226

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36640-0460

  • Providence Hospital - Mobile AL

    Mobile, Alabama, 36685

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital

    Mount Holly, New Jersey, 08060

  • Sarah Cannon-Minnie Pearl Cancer Center

    Nashville, Tennessee, 37203

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • Baptist Hospital

    Nashville, Tennessee, 37236

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

    New York, New York, 10019

  • New York Presbyterian Hospital - Cornell Campus

    New York, New York, 10021

  • Summit Medical Center

    Oakland, California, 94609

  • St. Joseph Hospital - Orange

    Orange, California, 92868-3849

  • Huntington Memorial Hospital

    Pasadena, California, 91109-7013

  • Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Mercy Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15219

  • Women and Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

  • Carilion Health System - Cancer Center of Western Virginia

    Roanoke, Virginia, 24033

  • Highland Hospital of Rochester

    Rochester, New York, 14620

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Park Nicollet Clinic

    Saint Louis Park, Minnesota, 55416

  • Columbia Lewis-Gale Medical Center

    Salem, Virginia, 24153

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84132

  • Latter Day Saints Hospital

    Salt Lake City, Utah, 84143

  • Donald N. Sharp Memorial Community Hospital

    San Diego, California, 92123

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94143-0128

  • John Wayne Cancer Institute

    Santa Monica, California, 90404

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259

  • University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • Lester E. Cox Medical Centers

    Springfield, Missouri, 65807-1988

  • St. Louis University Health Sciences Center

    St Louis, Missouri, 63110-2500

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Bayfront Medical Center

    St. Petersburg, Florida, 33701

  • Martin Memorial Cancer Medical Center

    Stuart, Florida, 34995

  • Tallahassee Memorial Healthcare

    Tallahassee, Florida, 32308

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • Toledo Hospital

    Toledo, Ohio, 43606

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Kent County Memorial Hospital

    Warwick, Rhode Island, 02886

  • Lombardi Cancer Center

    Washington D.C., District of Columbia, 20007

  • Henry Ford Medical Center - West Bloomfield

    West Bloomfield, Michigan, 48322

  • CCOP - Christiana Care Health Services

    Wilmington, Delaware, 19899

  • York Cancer Center

    York, Pennsylvania, 17403

Other trials in United States

Ireland2 sites

  • Cork University Hospital

    Cork

  • St. Vincent's University Hospital

    Dublin, 4

Other trials in Ireland

Australia1 site

  • Peter MacCallum Cancer Institute

    East Melbourne, Victoria, 8006

Other trials in Australia

About this study

Official title: A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women With Clinical T1-2 N0 Breast Cancer

RATIONALE: Biopsy of sentinel lymph nodes and bone marrow may improve the ability to detect and determine the extent of cancer.

PURPOSE: Phase III prognostic study of sentinel lymph node metastases and bone marrow metastases in women who have stage I or stage IIA breast cancer.

Read the detailed description

OBJECTIVES:

  • Estimate the prevalence and evaluate the prognostic significance of sentinel lymph node micrometastases detected by immunohistochemistry in women with stage I or IIA breast cancer.
  • Estimate the prevalence and evaluate the prognostic significance of bone marrow micrometastases detected by immunocytochemistry in these patients.
  • Evaluate the hazard rate for regional recurrence in women whose sentinel nodes are negative by hematoxylin and eosin (H\&E) staining.
  • Provide a mechanism for identifying women whose sentinel nodes contain metastases detected by H\&E so that these women can be considered as candidates for ACOSOG-Z0011.
Conditions
Breast Cancer
Being tested
immunohistochemistry staining method, lymphangiography, sentinel lymph node biopsy, therapeutic conventional surgery, whole breast irradiation
Keywords
stage IA breast cancer, stage IB breast cancer, stage II 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.

Study groups in NCT00003854
Study groupRoleWhat they receive
Surgery + radiotherapy + adjuvant therapyExperimentalPatients undergo bilateral anterior iliac crest bone marrow aspiration to test for presence of micrometastases. Patients then undergo breast-conserving therapy comprising segmental mastectomy and sentinel lymph node dissection (SLND) with planned postoperative whole-breast radiotherapy and systemic adjuvant therapy. The SLND comprises ipsilateral axillary sentinel node identification and histopathology. Patients with no sentinel node identified intraoperatively and patients with sentinel node metastasis identified by hematoxylin and eosin (H\&E) who choose not to be registered to ACOSOG-Z0011 undergo axillary lymph node dissection involving removal of at least level I and II nodes. All patients undergo whole-breast radiotherapy (excluding a supraclavicular field) 5 days a week for a maximum of 8 weeks. Patients are followed at 30 days; at 6, 12, 18, 24, 30, and 36 months; and then annually until 10 years after surgery.
Receives: Other: immunohistochemistry staining method; Procedure: lymphangiography; Procedure: sentinel lymph node biopsy; Procedure: therapeutic conventional surgery; Radiation: whole breast irradiation

What is being measured

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

  1. Overall survival

    Measured: Up to 10 years

Secondary outcomes (2)

  1. Disease-free survival

    Measured: Up to 10 years

  2. Axillary recurrence following detection of negative SN with H&E staining in women who did not have an ALND

    Measured: Up to 10 years

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 1999
  3. Primary completionAug 2006
  4. Study completionJul 2011

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 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4,590 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003854
Sponsor's protocol ID
ACOSOG-Z0010
Other IDs
GUMC-00152, CDR0000067017
Status last verified
Jul 2016
First submitted
1 Nov 1999
Last updated
13 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Olson JA Jr, McCall LM, Beitsch P, Whitworth PW, Reintgen DS, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Giuliano AE; American College of Surgeons Oncology Group Trials Z0010 and Z0011. Impact of immediate versus delayed axillary node dissection on surgical outcomes in breast cancer patients with positive sentinel nodes: results from American College of Surgeons Oncology Group Trials Z0010 and Z0011. J Clin Oncol. 2008 Jul 20;26(21):3530-5. doi: 10.1200/JCO.2007.15.5630.

    PubMed 18640934

  • Hunt KK, Ballman KV, McCall LM, Boughey JC, Mittendorf EA, Cox CE, Whitworth PW, Beitsch PD, Leitch AM, Buchholz TA, Morrow MA, Giuliano AE. Factors associated with local-regional recurrence after a negative sentinel node dissection: results of the ACOSOG Z0010 trial. Ann Surg. 2012 Sep;256(3):428-36. doi: 10.1097/SLA.0b013e3182654494.

    PubMed 22868365

  • Giuliano AE, Hawes D, Ballman KV, Whitworth PW, Blumencranz PW, Reintgen DS, Morrow M, Leitch AM, Hunt KK, McCall LM, Abati A, Cote R. Association of occult metastases in sentinel lymph nodes and bone marrow with survival among women with early-stage invasive breast cancer. JAMA. 2011 Jul 27;306(4):385-93. doi: 10.1001/jama.2011.1034.

    PubMed 21791687

  • Wilke LG, Ballman KV, McCall LM, Giuliano AE, Whitworth PW, Blumencranz PW, Reintgen DS, Burak WE, Leitch AM, Hunt KK. Adherence to the National Quality Forum (NQF) breast cancer measures within cancer clinical trials: a review from ACOSOG Z0010. Ann Surg Oncol. 2010 Aug;17(8):1989-94. doi: 10.1245/s10434-010-0980-9. Epub 2010 Mar 23.

    PubMed 20309640

  • Wilke LG, McCall LM, Posther KE, Whitworth PW, Reintgen DS, Leitch AM, Gabram SG, Lucci A, Cox CE, Hunt KK, Herndon JE 2nd, Giuliano AE. Surgical complications associated with sentinel lymph node biopsy: results from a prospective international cooperative group trial. Ann Surg Oncol. 2006 Apr;13(4):491-500. doi: 10.1245/ASO.2006.05.013. Epub 2006 Mar 2.

    PubMed 16514477

  • Leitch AM, Beitsch PD, McCall LM, Posther K, Newman LA, Herndon JE 2nd, Hunt KK, Giuliano AE. Patterns of participation and successful patient recruitment to American College of Surgeons Oncology Group Z0010, a phase II trial for patients with early-stage breast cancer. Am J Surg. 2005 Oct;190(4):539-42. doi: 10.1016/j.amjsurg.2005.06.024.

    PubMed 16164916

  • Posther KE, McCall LM, Blumencranz PW, Burak WE Jr, Beitsch PD, Hansen NM, Morrow M, Wilke LG, Herndon JE 2nd, Hunt KK, Giuliano AE. Sentinel node skills verification and surgeon performance: data from a multicenter clinical trial for early-stage breast cancer. Ann Surg. 2005 Oct;242(4):593-9; discussion 599-602. doi: 10.1097/01.sla.0000184210.68646.77.

    PubMed 16192820

  • Katz MS, McCall L, Ballman K, Jagsi R, Haffty BG, Giuliano AE. Nomogram-based estimate of axillary nodal involvement in ACOSOG Z0011 (Alliance): validation and association with radiation protocol variations. Breast Cancer Res Treat. 2020 Apr;180(2):429-436. doi: 10.1007/s10549-020-05555-z. Epub 2020 Feb 10.

    PubMed 32043193

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing immunohistochemistry staining method, lymphangiography and sentinel lymph node biopsy in people with Breast Cancer, run by Alliance for Clinical Trials in Oncology at 116 sites in 3 countries.

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

Who may be eligible to take part?

The sponsor lists 14 inclusion and 9 exclusion criteria. 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 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, Ireland, Australia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall survival (time frame: Up to 10 years). 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 NCT00003854, which also lists 8 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 13 Jul 2016; AzTrials last refreshed its copy on 3 Nov 2026.

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