A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node
N/A
N/A
Female
Breast Cancer
Trial Information
A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Outcome Measure:
Disease-free survival
Outcome Time Frame:
January 2013
Safety Issue:
No
Principal Investigator
Viviana E. Galimberti
Investigator Role:
Study Chair
Investigator Affiliation:
European Institute of Oncology
Authority:
United States: Federal Government
Study ID:
CDR0000339581
NCT ID:
NCT00072293
Start Date:
December 2001
Completion Date:
Related Keywords:
- Breast Cancer
- 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
- Breast Neoplasms
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