Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases - Full Text View

Sponsor:	International Breast Cancer Study Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00072293

Purpose

RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection.

PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases.

Condition	Intervention	Phase
Breast Cancer	Procedure: conventional surgery	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Designated as safety issue: No ]
Systemic disease-free survival [ Designated as safety issue: No ]
Incidence of reappearance of disease in the undissected axilla [ Designated as safety issue: No ]
Sites of first failure [ Designated as safety issue: No ]
Correlation of pathological features with outcome [ Designated as safety issue: No ]
Short and long term surgical complications [ Designated as safety issue: No ]

Estimated Enrollment:	1960
Study Start Date:	December 2001

Detailed Description:

OBJECTIVES:

Primary

Compare disease-free survival of women with clinically node-negative breast cancer with sentinel lymph node micrometastases treated with surgical resection with or without axillary dissection.

Secondary

Compare overall survival of patients treated with these regimens.
Compare the incidence of reappearance of disease in the undissected axilla, sites of first failure, and short- and long-term surgical complications in patients treated with these regimens.
Correlate pathological features of disease with outcome in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to participating center, menopausal status (pre- vs postmenopausal), and preoperative sentinel node biopsy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo surgical resection of the primary tumor with axillary lymph node dissection.
Arm II: Patients undergo surgical resection of the primary tumor without axillary lymph node dissection.

Patients in both arms may receive adjuvant therapy based on biological factors determined on the primary tumor or subsequent disease recurrence.

Patients are followed every 4 months for 1 year, every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 1,960 patients will be accrued for this study.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and unifocal breast carcinoma
Largest tumor lesion ≤ 5 cm
Palpable or nonpalpable breast lesion
- Preoperative radioactive occult lesion localization, hook wire, or other method of localization required for nonpalpable lesions
Prior (preoperative) or planned (intraoperative) sentinel node biopsy required
- At least 1 micrometastatic (i.e., no greater than 2 mm) sentinel lymph node with no extracapsular extension
No clinical evidence of distant metastases
- No suspicious manifestation of metastases that cannot be ruled out by x-ray, MRI, or CT scan, including the following:
  - Skeletal pain of unknown cause
  - Elevated alkaline phosphatase
  - Bone scan showing hot spots
No palpable axillary lymph node(s)
No Paget's disease without invasive cancer
Hormone receptor status:
- Estrogen receptor and progesterone receptor known

PATIENT CHARACTERISTICS:

Age

Any age

Sex

Female

Menopausal status

Any status

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

See Disease Characteristics

Renal

Not specified

Other

Not pregnant or nursing
No other prior or concurrent malignancy except the following:
- Adequately treated basal cell or squamous cell skin cancer
- Adequately treated carcinoma in situ of the cervix
- Adequately treated in situ melanoma
- Contralateral or ipsilateral carcinoma in situ of the breast
No psychiatric, addictive, or other disorder that may compromise ability to give informed consent
Geographically accessible for follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

See Disease Characteristics

Other

No prior systemic therapy for breast cancer
More than 1 year since prior chemopreventive agent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072293

Hide Study Locations

Locations

Australia, New South Wales
Lismore Base Hospital	Recruiting
Lismore, New South Wales, Australia, 2480
Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166
Mater Hospital - North Sydney	Recruiting
North Sydney, New South Wales, Australia, 2060
Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166
Riverina Cancer Care Centre	Recruiting
Wagga Wagga, New South Wales, Australia, 2650
Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166
Westmead Institute for Cancer Research at Westmead Hospital	Recruiting
Westmead, New South Wales, Australia, 2145
Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166
St Vincents Hospital	Recruiting
Lismore, New South Wales, Australia, 2480
Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166
Sydney Cancer Centre at Royal Prince Alfred Hospital	Recruiting
Sydney, New South Wales, Australia, 2050
Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166
Royal North Shore Hospital	Recruiting
St. Leonards, New South Wales, Australia, 2065
Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166
Australia, South Australia
Royal Adelaide Hospital Cancer Centre	Recruiting
Adelaide, South Australia, Australia, 5000
Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166
Australia, Victoria
Royal Melbourne Hospital	Recruiting
Parkville, Victoria, Australia, 3050
Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166
Australia, Western Australia
St. John of God Hospital - Bunbury	Recruiting
Bunbury, Western Australia, Australia, 6230
Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166
Belgium
CHU Liege - Domaine Universitaire du Sart Tilman	Recruiting
Liege, Belgium, B-4000
Contact: Contact Person 32-4-366-7111
Brazil, Rio Grande do Sul
Hospital de Clinicas de Porto Alegre	Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Contact: Carlos H. Menke, MD, PhD 55-51-9986-9736 menke@hcpa.ufrgs.br
Denmark
Horsholm Sygenus	Recruiting
Horsholm, Denmark, 2970
Contact: Hanne Galatius, MD 45-48-296-961 haga@noh.regionh.dk
France
Institut Gustave Roussy	Recruiting
Villejuif, France, F-94805
Contact: Contact Person 33-1-4211-4339
Italy
Centro di Riferimento Oncologico - Aviano	Recruiting
Aviano, Italy, 33081
Contact: Ezio Candiani, MD 39-4-3465-9257 ecandiani@cro.it
European Institute of Oncology	Recruiting
Milan, Italy, 20141
Contact: Viviana E. Galimberti 39-02-5748-9725 viviana.galimberti@ieo.it
Fondazione Salvatore Maugeri	Recruiting
Pavia, Italy, I-27100
Contact: Corrado Tinterri, MD 39-03-8259-2272 ctinterri@fsm.it
Istituto Scientifico H. San Raffaele	Recruiting
Milan, Italy, 20132
Contact: Contact Person 39-2-2643-2754
Ospedale Alessandro Manzoni	Recruiting
Lecco, Italy, 23900
Contact: Angelo Recalcati 39-3-4148-9312 a.recalcati@tiscalinet.it
Ospedali Riuniti di Bergamo	Recruiting
Bergamo, Italy, 24100
Contact: Carlo Tondini, MD 39-03-526-6424 carlo.tondoni@ospedaliriuniti.bergamo.it
Universita di Ferrara	Recruiting
Ferrara, Italy, 44100
Contact: Paolo Carcoforo, MD 39-05-3223-6385 ccf@unife.it
University of Bologna Medical School	Recruiting
Bologna, Italy, 40138
Contact: Mario Taffurelli, MD 39-051-636-3584
New Zealand
North Shore Hospital	Recruiting
Auckland, New Zealand
Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166
Waikato Hospital	Recruiting
Hamilton, New Zealand, 2020
Contact: ANZ BCTG Operations Office - Department of Surgical Oncology 61-2-4985-0166
Peru
Instituto Nacional de Enfermedades Neoplasicas	Recruiting
Lima, Peru, 34
Contact: Julio E. Abugattas 51-1-710-6900 ext. 2242 jabugattas@inen.sld.pe
Slovenia
Institute of Oncology - Ljubljana	Recruiting
Ljubljana, Slovenia, Sl-1000
Contact: Jurij Lindtner, MD 386-1-587-9535
Switzerland
Centre Hospitalier Universitaire Vaudois	Recruiting
Lausanne, Switzerland, CH-1011
Contact: Jean-Francois Delaloye, MD 41-21-314-0146 jean-francois.delaloye@chuv.ch
Oncology Institute of Southern Switzerland	Recruiting
Bellinzona, Switzerland, CH-6500
Contact: Olivia Pagani, MD 41-91-811-3395 olivia.pagani@ibcsg.org
Kantonspital Aarau	Recruiting
Aarau, Switzerland, CH-5001
Contact: Dimitri Sarlos 41-62-838-5065 dimtri.sarlos@ksa.ch
Kantonsspital - St. Gallen	Recruiting
St. Gallen, Switzerland, CH-9007
Contact: Monika Bamert, MD 41-71-494-1161 monika.bamert@kssg.ch
Inselspital Bern	Recruiting
Bern, Switzerland, CH-3010
Contact: Stefan Aebi, MD 41-31-6321-661 stefan.aebi@insel.ch

Sponsors and Collaborators

International Breast Cancer Study Group

Investigators

Study Chair:	Viviana E. Galimberti	European Institute of Oncology
Investigator:	Umberto Veronesi, MD	European Institute of Oncology

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000339581, IBCSG-23-01, EU-20319
Study First Received:	November 4, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00072293 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage II breast cancer
stage I breast cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009