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.

Back to the List
Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
February 2004
NCT00003857Uploaded 04-09-2017
Access via NCI by Request
PDS UID: nci-data-353
Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus Radiation Therapy for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the treatment comparison between Arm 1 and Arm 2 in trial NCT00003857.
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if radiation therapy is more effective than observation, with or without tamoxifen, in treating ductal carcinoma in situ. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of observation, with or without tamoxifen, in treating women who have ductal carcinoma in situ.
ConditionsBreast Cancer
Intervention TypeDrug: tamoxifen citrate
Procedure: adjuvant therapy
Radiation: radiation therapy
Drug(s)Drug: tamoxifen citrate
Total Enrolled636
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionObservation +/- tamoxifen for 5 years - Active Comparator
Radiation therapy +/- tamoxifen for 5 years - Experimental
Secondary IDCDR0000067020
PubMed (PMID)25605856
Collaborator(s)National Cancer Institute (NCI)
Cancer and Leukemia Group B
NCIC Clinical Trials Group
NRG Oncology
Region(s)United States
Canada
Age RangeMinimum Age: 26 Years
Maximum Age: 120 Years
Files: NCT00003857-D1
Data DictionaryNCT00003857-D1-Data-Dictionary.pdf
DATANCT00003857-D1-Dataset.csv
OTHERREADME.pdf
© 2021 Project Data Sphere
All rights reserved
Privacy PolicyTerms of Use