Bone Metastasis and Surgery in Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125630
• Other study ID #: BOMET MF14-01
• Secondary ID: PROTOCOL BOMET M
• Status: Completed
• Start date: January 2014
• Est. completion date: June 2019

Study information

• Verified date: July 2019
• Source: Federation of Breast Diseases Societies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neoplasm Metastasis
• Surgery

Intervention

Procedure:
• Surgery
Surgery to primary tumor

Drug:
• Systemic therapy
Systemic therapy based on tumor phenotype

Locations

Country	Name	City	State
Turkey	Istanbul University Medical faculty	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Federation of Breast Diseases Societies

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Years	5 years
Secondary	Locoregional progression	Number	5 years