Bone Metastasis and Surgery in Breast Cancer

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federation of Breast Diseases Societies
• Treatments: Hormones

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