Bone Metastasis and Surgery in Breast Cancer
Conditions
Breast Cancer - Surgery
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Metastatic breast carcer, Bone metastasis, surgery
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention
Name: Surgery Type: Procedure
Name: Systemic therapy Type: Drug
Overall Status
Recruiting
Summary
A randomized 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 randomized 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 diagnosed with biopsy
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Female
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
Location
Istanbul University Medical faculty
Istanbul, Turkey
Status: Recruiting
Contact: Vahit Ozmen, MD - 905322150777 - vozmen@istanbul.edu.tr
Start Date
April 2014
Completion Date
April 2017
Sponsors
Federation of Breast Diseases Societies
Source
Federation of Breast Diseases Societies
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page