CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 390 enrolled
Drug / intervention
palliative surgery +3 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01242800
NCT01242800N/ACompleted

A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients With Metastatic Breast Cancer

Eastern Cooperative Oncology Group·interventional·Posted Nov 17, 2010·Updated Jun 29, 2023

In Brief

A clinical study evaluating palliative surgery, therapeutic conventional surgery, and 2 other interventions for Breast Cancer and Stage IV Breast Cancer. Completed, enrolled 390 participants across 377 sites in 5 countries.

Detailed Summary

RATIONALE: 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Israel, Saudi Arabia, South Africa, United States

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 17, 2010
Enrollment StartMay 16, 2011
Primary CompletionDec 10, 2019
Study CompletionDec 21, 2022
TodayJul 2, 2026
Enrollment to primary: 8.6 yearsPosted 15.6 years ago

Interventions

palliative surgeryprocedure

Undergo standard palliative surgery

therapeutic conventional surgeryprocedure

Undergo early surgery

palliative radiation therapyradiation

Undergo standard palliative radiotherapy

radiation therapyradiation

Undergo radiotherapy