Bone Metastasis and Surgery in Breast Cancer

Federation of Breast Diseases Societies

Status

Completed

Conditions

Breast Cancer

Surgery

Treatments

Procedure: Surgery

Drug: Systemic therapy

Study type

Observational

Funder types

Other

Identifiers

NCT02125630

PROTOCOL BOMET MF14-01 (Other Identifier)

BOMET MF14-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

460 patients

Sex

Female

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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