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Bone Metastasis and Surgery in Breast Cancer

This study is currently recruiting participants.
Verified August 2016 by Federation of Breast Diseases Societies
Sponsor:
ClinicalTrials.gov Identifier:
NCT02125630
First Posted: April 29, 2014
Last Update Posted: August 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Federation of Breast Diseases Societies
  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
Breast Cancer Surgery Procedure: Surgery Drug: Systemic therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: 3 years ]

Estimated Enrollment: 288
Study Start Date: February 2016
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
Systemic therapy based on tumor phenotype
Other Name: Chemotherapy, hormone therapy
Active Comparator: Primary surgery
Standart surgery
Procedure: Surgery
Surgery to primary tumor
Other Name: mastectomy, lumpectomy

Detailed Description:
This 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. Our goal is to test if primary surgery improves overall survival in bone only metastasis diagnosed with biopsy
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: TURKISH FEDERATION OF BREAST DISEASE SOCITIES )
First Submitted: April 27, 2014
First Posted: April 29, 2014
Last Update Posted: August 11, 2016
Last Verified: August 2016

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes