At a glance
ClinicalIndex Comparison Record- ✓Resectable invasive adenocarcinoma of breast confirmed by core/open biopsy, fine needle aspiration cytology with positive clinical exam, or imaging
- ✓Clinically negative lymph nodes with no prior removal of ipsilateral axillary lymph nodes
- ✓No skin involvement including ulceration, erythema, infiltration, peau d'orange, or skin edema
- ✓No bilateral malignancy or suspicious mass in contralateral breast unless proven nonmalignant
- ✕Prior or concurrent breast implants
- ✕Prior breast malignancy except lobular carcinoma in situ
- ✕Prior malignancy within 5 years except skin cancer, cervical carcinoma in situ, or ipsilateral/contralateral LCIS
- ✕Hepatic, renal, or cardiovascular systemic disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Phase III Clinical Trial to Compare Sentinel Node Resection to Conventional Axillary Dissection in Clinically Node-Negative Breast Cancer Patients
In Brief
A Phase 3 clinical trial evaluating conventional surgery and Sentinel node resection followed by node examination for Breast Cancer. Completed, enrolled 5,611 participants across 78 sites in 3 countries.
Detailed Summary
RATIONALE: Removing the sentinel lymph nodes and examining them under a microscope may help plan more effective surgery for breast cancer. It is not yet known if surgery to remove the sentinel lymph nodes is more effective with or without removal of the lymph nodes in the armpit in treating breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to remove the sentinel lymph nodes with or without removal of lymph nodes in the armpit in treating women who have breast cancer.
Study Details
Timeline
Interventions
Sentinel node resection immediately followed by axillary dissection.
Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.