< Back to Results
A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel NodeUnique Dataset IDnci-data-367ClinicalTrial.gov IDNCT00003855
Clinical Trial Title
A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node
Trial Summary and Conditions
RATIONALE: Surgery to remove lymph nodes in the armpit may remove cancer cells that have spread from tumors in the breast. PURPOSE: Randomized phase III trial to determine the effectiveness of removing lymph nodes in the armpit in treating women who have stage I or stage IIA breast cancer.
See data dictionary for more details.
OBJECTIVES: Long term: To assess whether overall survival for patients randomized to Arm 2 (no immediate ALND) is essentially equivalent to (or better than) than that for patients assigned to Arm 1 (completion ALND). Short term: To quantify and compare the surgical morbidities associated with SLND plus ALND versus SLND alone. OUTLINE: This is a randomized study. After segmental mastectomy and sentinel lymph node dissection, patients are stratified according to age (50 and under vs over 50), estrogen receptor status (positive vs negative), and tumor size (no greater than 1 cm vs greater than 1 cm but no greater than 2 cm vs greater than 2 cm). Patients are randomized to one of two treatment arms.
Primary: Overall survival [ Time Frame: Up to 10 years ] Morbidity [ Time Frame: Up to 10 years ] Disease-free survival [ Time Frame: Up to 10 years ]
Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):
This dataset will allow users to reproduce the primary analysis publication (PubMed ID: 21304082) for study NCT00003855.
Available Downloads: NCT00003855-D1
To gain access to the data and analytic tools click here.
Data Dictionary: NCT00003855-D1-Data-Dictionary.pdf