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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
2007-08
NCT00003855Uploaded 07-07-2018
Access via NCI by Request
PDS UID: nci-data-367
A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the primary analysis publication (PubMed ID: 21304082) for study NCT00003855.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: 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.
ConditionsBreast Cancer
Intervention TypeProcedure: axillary lymph node dissection
Radiation: whole breast irradiation
Drug(s)N/A
Total Enrolled605
RandomizationRandomized
Blinding MethodNone
Arms InterventionSurgery + radiotherapy - Experimental
Radiotherapy - Active Comparator
Secondary IDGUMC-00153
PubMed (PMID)23290275
22820938
18640934
23338762
23037494
21327455
21304082
20739842
17485711
28898379
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Ireland
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT00003855-D1
Data DictionaryNCT00003855-D1-Data-Dictionary.pdf
DATANCT00003855-D1-Dataset.csv
OTHERREADME.pdf
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