Alert icon

To align with industry best practices for security and data integrity, Project Data Sphere is requiring users to upgrade their browsers to one that supports encryption protocol TLS 1.2 by December 15, 2017. On that date, Project Data Sphere will disable support of browsers that permit SSL 3.0/TLS 1.0. To prevent any disruption to your access to Project Data Sphere, you must take action.
This browser was not recognized and may not be compatible with TLS 1.2 or higher. Please check with the browser's developer to confirm.
To view information about this, please visit the FAQ. If you have any further questions, please contact us.

The Project Data Sphere Cancer Research Platform will be unavailable from 5 PM Eastern Time on Friday, 10/20 until 1 AM on Monday, 10/23 for necessary maintenance.

Breast

ACOSOG Z0011: 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 Data Set IDBreast_Allianc_1999_181
DownloadableYes
SponsorAlliance for Clinical Trials in OncologyData ProviderAlliance for Clinical Trials in OncologyTotal Study Enrolled Patients891Comparator (Control) Arm Enrolled Patients436Experimental (Active) Arm Enrolled Patients420RandomizationYesClinicalTrial.gov IDNCT00003855ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00003855
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataBoth comparator and experimental arm dataIntervention TypeRadiation, SurgeryData Set TypeADS

Clinical Trial Title

ACOSOG Z0011: 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

Control and experimental arm data files include data on efficacy, demographics, etc. See the data dictionary provided for more details.

Study Objectives

OBJECTIVES: Primary 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.

Outcome Measures

Overall survival Disease-free survival

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: Z0011Protocol.pdf

CRF: Z0011CRFs.pdf

DATA DICTIONARY: z0011_datadictionary.pdf

DATA (ACTIVE ARM): efficacy.csv