Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Current guidelines lack definitive evidences about the relative benefits of locoregional surgery for the primary tumor in de novo stage IV breast cancer. The aim of this study (SYSBTC-001) was to investigate the role of locoregional surgery for primary tumor in de novo stage IV breast cancer.

Official Title
-----------------
Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients

Conditions
-----------------
Breast Neoplasm Female, Surgery, Advanced Breast Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Operable stage IV breast cancer patients,whose primary lesion is invasive breast cancer confirmed by pathology, and metastases can be confirmed by pathology or imageology examination. ECOG-PS 0-2. Bone marrow, liver and kidney should be fully functional. Patients received the locoregional surgery of the primary tumor in de novo in our center, or didn't received the locoregional surgery of the primary tumor in de novo. For the patient who accepted systematic treatment before operation, the systematic treatment must be administered within a year since diagnosed. Exclusion Criteria: Accompanied with other primary malignant tumors. Patients who can't plan for follow-up effectively and regularly. Multiple liver metastasis and ALT/AST four times higher than normal at patients' first diagnosis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Locoregional surgery<br> | Procedure: Locoregional surgery<br>* Patients had pathologically confirmed operable stage IV breast infiltrating carcinoma at initial presentation, and had locoregional surgery for the breast cancer.<br>|
| No surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | The association between locoregional surgery and overall survival (OS), which defined as the time from the beginning of diagnosis of breast cancer to the death with any causes. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locoregional progression free survival | Defined as time between the time of diagnosis and the time of locoregional recurrence, or death occurred. | 5 years | 
| Distant progression free survival | Distant disease free survival (D-DFS), which defined as the time from the diagnosis of de novo stage IV breast cancer to the confirmed time of distant progression, or death due to any other cause. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Neoplasm Female, Locoregional surgery, In de novo stage IV brest cancer, Overall survival, Locoregional progression free survival, Distant progression free survival