N/A
N=934
Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00072293 ↗Enrolled (actual)
934
Serious AEs
0.1%
Results posted
May 2016
Primary outcome: Primary: 5-year Disease-Free Survival — 84.4; 87.8 percentage of participants — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Axillary lymph node dissection (Procedure); No axillary lymph node dissection (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- ETOP IBCSG Partners Foundation
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 5-year Disease-Free Survival |
84.4; 87.8 | 0.004 sig |
| SECONDARY 5-year Overall Survival |
97.6; 97.5 | 0.73 |
| SECONDARY Site of Recurrence |
10; 8; 1; 5; 3; 9 | — |
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 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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00072293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.