Local Surgery for Metastatic Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Primary surgery

• Registration Number: NCT00557986
• Lead Sponsor: Federation of Breast Diseases Societies

Brief Summary

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

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 Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-13
• Study First Submitted QC: 2007-11-13
• Study First Posted: 2007-11-14
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-10
• Last Update Posted: 2016-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 281

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Primary surgery	Surgery group

Primary Outcome Measures

Name	Time	Method
Measure: all cause mortality	5 years

Secondary Outcome Measures

Name	Time	Method
Quality of life	5 year
mordities	5 years

Trial Locations

Locations (7)

Istanbul University Medical faculty; 🇹🇷 Istanbul, Turkey

Marmara Univesity School of Medicine; 🇹🇷 Istanbul, Turkey

Cukurova University; 🇹🇷 Adana, Turkey

Izzet Baysal University; 🇹🇷 Bolu, Turkey

Adnan Menderes University; 🇹🇷 Aydin, Turkey

Cumhuriyet University Medical School; 🇹🇷 Sivas, Turkey

Ankara Onkoloji Hastanesi; 🇹🇷 Ankara, Turkey