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Completed

NCT Number: NCT00557986

Local Surgery for Metastatic Breast Cancer

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

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University, Adana, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary surgery

Procedure

Primary breast surgery before systemic therapy

Primary outcomes

  1. Measure: all cause mortality

    Time frame: 5 years

Secondary outcomes

  1. Quality of life

    Time frame: 5 year

  2. mordities

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Federation of Breast Diseases Societies

Other

Collaborators

  • Abant Izzet Baysal University
  • Istanbul University
  • Marmara University

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Nov 14, 2007
Registry last updated
Aug 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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