Status:
COMPLETED
Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases
Lead Sponsor:
ETOP IBCSG Partners Foundation
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 whet...
Detailed Description
OBJECTIVES: * 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 diss...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2017
Estimated Enrollment :
931 Patients enrolled
Trial Details
Trial ID
NCT00072293
Start Date
December 1 2001
End Date
March 31 2017
Last Update
January 23 2018
Active Locations (31)
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1
Lismore Base Hospital
Lismore, New South Wales, Australia, 2480
2
St Vincents Hospital
Lismore, New South Wales, Australia, 2480
3
Mater Hospital - North Sydney
North Sydney, New South Wales, Australia, 2060
4
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065