Local Surgery for Metastatic Breast Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Primary surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: all cause mortality |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 5 year | 
| mordities |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
1-Metastatic breast cancer, 2-Surgery, 3-Survival