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
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Carcinoma With Bone Metastasis Only
Primary Surgery
Procedure: Surgery
Drug: Systemic therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Primary Surgery in Patients With Stage IV Breast Cancer With Bone Metastasis Only

Resource links provided by NLM:


Further study details as provided by Federation of Breast Diseases Societies:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 288
Study Start Date: April 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Systemic therapy
Standart chemotherapy
Drug: Systemic therapy
Active Comparator: Primary surgery
Standart surgery
Procedure: Surgery

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02125630

Locations
Turkey
Istanbul University Medical faculty Recruiting
Istanbul, Turkey
Contact: Vahit Ozmen, MD    905322150777    vozmen@istanbul.edu.tr   
Sub-Investigator: Abdullah Igci, MD         
Sub-Investigator: Mahmut Muslumanoglu, MD         
Sponsors and Collaborators
Federation of Breast Diseases Societies
Investigators
Study Chair: Atilla Soran, MD, MPH Magee-Womens Hospital of UPMC
Principal Investigator: Serdar Ozbas, MD Guven Hospital
  More Information

No publications provided

Responsible Party: Federation of Breast Diseases Societies
ClinicalTrials.gov Identifier: NCT02125630     History of Changes
Other Study ID Numbers: BOMET MF14-01, PROTOCOL BOMET MF14-01
Study First Received: April 27, 2014
Last Updated: April 28, 2014
Health Authority: Turkey: Ethics Committee

Keywords provided by Federation of Breast Diseases Societies:
Metastatic breast carcinoma
Bone metastasis
Primary surgery

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Breast Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Carcinoma
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 16, 2014