Breast Cancer, Surgery
Conditions
Keywords
Metastatic breast carcer, Bone metastasis, surgery
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.
Interventions
PROCEDURESurgery
Surgery to primary tumor
DRUGSystemic therapy
Systemic therapy based on tumor phenotype
Sponsors
Federation of Breast Diseases Societies
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years | Years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Locoregional progression | 5 years | Number |
Countries
Turkey (Türkiye)
Outcome results
None listed