Bone Metastasis and Surgery in Breast Cancer

Completed

• Conditions: Breast Cancer; Surgery
• Interventions: Procedure: Surgery; Drug: Systemic therapy

• Registration Number: NCT02125630
• Lead Sponsor: Federation of Breast Diseases Societies

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-04-27
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-29
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 460

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neoadjuvant chemotherapy	Surgery	Standart chemotherapy followed by surgery
Neoadjuvant chemotherapy	Systemic therapy	Standart chemotherapy followed by surgery
Systemic therapy	Systemic therapy	Standart chemotherapy
Primary surgery	Surgery	Standart surgery

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years	Years

Secondary Outcome Measures

Name	Time	Method
Locoregional progression	5 years	Number

Trial Locations

Locations (1)

Istanbul University Medical faculty; 🇹🇷 Istanbul, Turkey