NCT02125630

Bone Metastasis and Surgery in Breast Cancer

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 460 (actual)
• Sponsor: Federation of Breast Diseases Societies · Academic / Other
• Sex: Female
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Surgery

Interventions

Type	Name	Description
PROCEDURE	Surgery	Surgery to primary tumor
DRUG	Systemic therapy	Systemic therapy based on tumor phenotype

Timeline

• Start date: 2014-01-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2014-04-29
• Last updated: 2019-07-31

Locations

1 site across 1 country: Turkey (Türkiye)