Bone Metastasis in Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Federation of Breast Diseases Societies
Sponsor:
Information provided by (Responsible Party):
Federation of Breast Diseases Societies
ClinicalTrials.gov Identifier:
NCT02125630
First received: April 27, 2014
Last updated: April 28, 2014
Last verified: April 2014

April 27, 2014
April 28, 2014
April 2014
April 2017   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02125630 on ClinicalTrials.gov Archive Site
Progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Bone Metastasis in Breast Cancer
The Effect of Primary Surgery in Patients With Stage IV Breast Cancer With Bone Metastasis Only

A randomized 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Metastatic Breast Carcinoma With Bone Metastasis Only
  • Primary Surgery
  • Procedure: Surgery
  • Drug: Systemic therapy
  • Active Comparator: Systemic therapy
    Standart chemotherapy
    Intervention: Drug: Systemic therapy
  • Active Comparator: Primary surgery
    Standart surgery
    Intervention: Procedure: Surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
288
April 2017
April 2017   (final data collection date for primary outcome measure)

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
Female
20 Years to 80 Years
No
Turkey
 
NCT02125630
BOMET MF14-01, PROTOCOL BOMET MF14-01
Yes
Federation of Breast Diseases Societies
Federation of Breast Diseases Societies
Not Provided
Study Chair: Atilla Soran, MD, MPH Magee-Womens Hospital of UPMC
Principal Investigator: Serdar Ozbas, MD Guven Hospital
Federation of Breast Diseases Societies
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP