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A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients With Metastatic Breast Cancer
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
Blinding MethodNone (Open Label)
Arms InterventionArm I - Active Comparator Arm II - Experimental
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)