Local Surgery for Metastatic Breast Cancer

August 10, 2016 updated by: Federation of Breast Diseases Societies

The Effect of Primary Surgical Treatment on Survival in Patients With Metastatic Breast Cancer at Diagnosis

Primary treatments for metastatic breast cancer are chemotherapy and radiation therapy, and surgery is reserved for tumor related complications such as bleeding. Retrospective studies showed that surgical removal of the primary tumor improves survival of patients with metastatic breast cancer at diagnosis. We hypothesis and testing that surgical removal of the primary tumor will lead to an improvement of overall survival

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomised, controled clinical trial. Our aim is to observe whether primary surgery improves survival in metastatic breast cancer. Women who have metastatic breast cancer at the initial diagnosis will be included in the study. There will be two study arms: primary surgery and systemic chemotherapy groups.

In the primary surgery group patients will have adjuvant therapies after they had the proper surgery. In the systemic chemotherapy group patients will be followed after their initial therapy and will have surgery only if they have locoregional problems (such as wide necrosis or bleeding, etc). During the follow-up period, patients will be seen in every 6 months.

Study Type

Interventional

Enrollment (Actual)

281

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey
        • Çukurova University
      • Ankara, Turkey
        • Ankara Onkoloji Hastanesi
      • Aydin, Turkey, 09100
        • Adnan Menderes University
      • Bolu, Turkey
        • Izzet Baysal University
      • Istanbul, Turkey
        • Istanbul University Medical Faculty
      • Istanbul, Turkey
        • Marmara Univesity School of Medicine
      • Sivas, Turkey
        • Cumhuriyet University Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with metastatic breast cancer at the initial diagnosis

Exclusion Criteria:

  • Women needs breast surgery at the time of initial diagnosis (such as bleeding, necrosis, etc)
  • who have systemic morbidity that do not allows her to be in the trial,
  • who have synchronous breast cancer at the contralateral breast,
  • who have a previous cancer history or another primary cancer history and metastasis at the past,
  • who have palpable lymph node/nodes at the contralateral axilla,
  • who do not agree to participate the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: A
Standard Systemic Therapy only group (no primary surgery)
Other: B
Surgery group
Procedure: Primary surgery
Primary breast surgery before systemic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure: all cause mortality
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 5 year
5 year
mordities
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federation of Breast Diseases Societies

Collaborators

Marmara University
Istanbul University
Abant Izzet Baysal University

Investigators

  • Study Chair: Atilla Soran, MD, MPH, University of Pittsburgh
  • Principal Investigator: Atilla Soran, MD, MPH, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

November 13, 2007

First Submitted That Met QC Criteria

November 13, 2007

First Posted (Estimate)

November 14, 2007

Study Record Updates

Last Update Posted (Estimate)

August 12, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MF07-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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