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 (Responsible Party):	International Breast Cancer Study Group
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: axillary lymph node dissection Procedure: No axillary lymph node dissection	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
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

U.S. FDA Resources

Further study details as provided by International Breast Cancer Study Group:

Primary Outcome Measures:

Disease-free survival [ Time Frame: January 2013 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Time Frame: January 2013 ] [ Designated as safety issue: No ]
Systemic disease-free survival [ Time Frame: January 2013 ] [ Designated as safety issue: No ]
Incidence of reappearance of disease in the undissected axilla [ Time Frame: January 2013 ] [ Designated as safety issue: No ]
Sites of first failure [ Time Frame: January 2013 ] [ Designated as safety issue: No ]
Correlation of pathological features with outcome [ Time Frame: January 2013 ] [ Designated as safety issue: No ]
Short and long term surgical complications [ Time Frame: January 2013 ] [ Designated as safety issue: No ]

Estimated Enrollment:	1960
Study Start Date:	December 2001
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Axillary Dissection	Procedure: axillary lymph node dissection Axillary lymph node dissection
No Intervention: No Axillary Dissection	Procedure: No axillary lymph node dissection Therapeutic conventional surgery

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

Show 31 Study Locations

Sponsors and Collaborators

International Breast Cancer Study Group

Investigators

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

Responsible Party:	International Breast Cancer Study Group
ClinicalTrials.gov Identifier:	NCT00072293 History of Changes
Other Study ID Numbers:	CDR0000339581, IBCSG 23-01
Study First Received:	November 4, 2003
Last Updated:	February 14, 2012
Health Authority:	United States: Federal Government

Keywords provided by International Breast Cancer Study Group:

stage IA breast cancer
stage IB breast cancer
stage II breast cancer
estrogen receptor-negative breast cancer

estrogen receptor-positive breast cancer
progesterone receptor-negative breast cancer
progesterone receptor-positive breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 24, 2012