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This dataset is available to Authorized Users of the Project Data Sphere Cancer Research Platform through an initiative with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH). To gain access to this dataset, you must complete the following steps:

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A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node

Unique Dataset IDNCT00003855
SponsorAlliance for Clinical Trials in Oncology Data ProviderNational Cancer InstituteTotal Study Enrolled Patients605RandomizationYesPubMed (PMID)21304082.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention Type Radiation, SurgeryDataset TypeOther

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.

Data Summary

See data dictionary for more details.

Study Objectives

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.

Outcome Measures

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):

NCI Description

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

DATA: NCT00003855-D1-Dataset.csv