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Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer

NCT01242800 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2023-06-29

Study results available
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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.

Conditions

Interventions

PROCEDURE

palliative surgery

Undergo standard palliative surgery

PROCEDURE

therapeutic conventional surgery

Undergo early surgery

RADIATION

palliative radiation therapy

Undergo standard palliative radiotherapy

RADIATION

radiation therapy

Undergo radiotherapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Eastern Cooperative Oncology Group

    lead NETWORK

Principal Investigators

  • Seema A. Khan, MD · Robert H. Lurie Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-16
Primary Completion
2019-12-10
Completion
2022-12-21

Countries

  • United States
  • Canada
  • Israel
  • Saudi Arabia
  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01242800 on ClinicalTrials.gov