Bone Metastasis and Surgery in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
A registry trial evaluating resection of the primary breast tumor in women presenting with de novo stage IV breast cancer with bone metastasis only. Previous reports of carefully selected patients presenting with stage IV breast cancer suggest that surgery on the primary tumor may result in improved survival, but this remains unproven. The early results of our ongoing trial MF07-01 trial (a phase III randomized controlled trial of breast cancer women with distant metastases at presentation who receive loco-regional treatment for intact primary tumor compared with those who do not receive such treatment) showed that patients with bone metastasis only have a trend toward improved survival with initial surgery.

Detailed Description
-----------------
This registry trial evaluating resection of the primary breast tumor in women presenting with de novo stage IV breast cancer with bone metastasis only. Previous reports of carefully selected patients presenting with stage IV breast cancer suggest that surgery on the primary tumor may result in improved survival, but this remains unproven. The early results of our ongoing trial MF07-01 trial (a phase III randomized controlled trial of breast cancer women with distant metastases at presentation who receive loco-regional treatment for intact primary tumor compared with those who do not receive such treatment) showed that patients with bone metastasis only have a trend toward improved survival with initial surgery. Our goal is to test if primary surgery improves overall survival in bone only metastasis.

Official Title
-----------------
The Effect of Primary Surgery in Patients With Stage IV Breast Cancer With Bone Metastasis Only

Conditions
-----------------
Breast Cancer, Surgery

Intervention / Treatment
-----------------
* Procedure: Surgery
* Drug: Systemic therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary breast tumor amenable for complete surgical resection Patients in good physical condition for receiving protocol driven locoregional and systemic treatment Patients eligible for sentinel lymph node (SLN) biopsy and receiving radiotherapy. Exclusion Criteria: Primary tumor not amenable for complete resection (such as tumor extending to neighboring tissues; T4a,c or inflammatory breast cancer; T4d) Primary tumor with extended infection, bleeding, or necrosis Patients with poor physical condition which prevents the patient from receiving protocol driven locoregional and systemic treatment Synchronous primary cancer at the contralateral breast Previous diagnosis of other cancers (excluding basal cell skin cancer Squamous cell skin cancer Cervical intraepithelial neoplasia) Clinically involved contralateral axillary nodes Patients not suitable for adequate follow-up Failure to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| Systemic therapy<br>Standart chemotherapy | Drug: Systemic therapy<br>* Systemic therapy based on tumor phenotype<br>* Other names: Chemotherapy, hormone therapy, biphosphanetes;|
| Primary surgery<br>Standart surgery | Procedure: Surgery<br>* Surgery to primary tumor<br>* Other names: mastectomy, lumpectomy;|
| Neoadjuvant chemotherapy<br>Standart chemotherapy followed by surgery | Procedure: Surgery<br>* Surgery to primary tumor<br>* Other names: mastectomy, lumpectomy;Drug: Systemic therapy<br>* Systemic therapy based on tumor phenotype<br>* Other names: Chemotherapy, hormone therapy, biphosphanetes;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Years | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locoregional progression | Number | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic breast carcer, Bone metastasis, surgery