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Type(s) of Cancer
Breast
Study Phase
Not Applicable
Study Completion Date
December 2019
NCT01242800Uploaded 05-13-2023
Access via NCI by Request
PDS UID: nci-data-521
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients With Metastatic Breast Cancer
Provider Information
Provider Data DescriptionThere are three submissions for PMID 34995128. This dataset, NCT01242800-D1, contains patient characteristics, disease status, and efficacy data at step 1. Dataset NCT01242800-D2 contains disease status, treatment, and efficacy data at step 2. Dataset NCT01242800-D3 contains longitudinal data on patient-reported outcomes.
SponsorEastern Cooperative Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: The primary tumor might be a source of re-seeding of distant sites and therefore elimination of this source of metastasizing cells by early local therapy may be of benefit. PURPOSE: This randomized phase III trial is studying early surgery to see how well it works compared to standard palliative therapy in treating patients with stage IV breast cancer.
ConditionsBreast Cancer
Stage IV Breast Cancer
Intervention TypeProcedure: palliative surgery
Procedure: therapeutic conventional surgery
Radiation: palliative radiation therapy
Radiation: radiation therapy
Drug(s)N/A
Total Enrolled390
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I - Active Comparator
Arm II - Experimental
Secondary IDECOG-E2108
PubMed (PMID)34995128
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Israel
Saudi Arabia
South Africa
Age Range18 Years to 120 Years (Adult, Older Adult)
Files: NCT01242800-D1
Data DictionaryNCT01242800-D1-Data-Dictionary_1.pdf
DATANCT01242800-D1-Dataset_2.csv
OTHERREADME.pdf
Files: NCT01242800-D2
Data DictionaryNCT01242800-D2-Data-Dictionary_1.pdf
DATANCT01242800-D2-Dataset_2.csv
OTHERREADME.pdf
Files: NCT01242800-D3
Data DictionaryNCT01242800-D3-Data-Dictionary_1.pdf
DATANCT01242800-D3-Dataset_1.csv
OTHERREADME.pdf
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