Local Surgery for Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Istanbul University
Abant Izzet Baysal University
Marmara University
Information provided by (Responsible Party):
Federation of Breast Diseases Societies
ClinicalTrials.gov Identifier:
NCT00557986
First received: November 13, 2007
Last updated: December 4, 2012
Last verified: November 2012
  Purpose

Primary treatments for metastatic breast cancer are chemotherapy and radiation therapy, and surgery is reserved for tumor related complications such as bleeding. Retrospective studies showed that surgical removal of the primary tumor improves survival of patients with metastatic breast cancer at diagnosis. We hypothesis and testing that surgical removal of the primary tumor will lead to an improvement of overall survival


Condition Intervention
Breast Cancer
Procedure: Primary surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Primary Surgical Treatment on Survival in Patients With Metastatic Breast Cancer at Diagnosis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Measure: all cause mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • mordities [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 281
Study Start Date: November 2007
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: A
Standard Systemic Therapy only group (no primary surgery)
Procedure: Primary surgery
Primary breast surgery before systemic therapy

Detailed Description:

This is a randomised, controled clinical trial. Our aim is to observe whether primary surgery improves survival in metastatic breast cancer. Women who have metastatic breast cancer at the initial diagnosis will be included in the study. There will be two study arms: primary surgery and systemic chemotherapy groups.

In the primary surgery group patients will have adjuvant therapies after they had the proper surgery. In the systemic chemotherapy group patients will be followed after their initial therapy and will have surgery only if they have locoregional problems (such as wide necrosis or bleeding, etc). During the follow-up period, patients will be seen in every 6 months.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with metastatic breast cancer at the initial diagnosis

Exclusion Criteria:

  • Women needs breast surgery at the time of initial diagnosis (such as bleeding, necrosis, etc)
  • who have systemic morbidity that do not allows her to be in the trial,
  • who have synchronous breast cancer at the contralateral breast,
  • who have a previous cancer history or another primary cancer history and metastasis at the past,
  • who have palpable lymph node/nodes at the contralateral axilla,
  • who do not agree to participate the trial
  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: NCT00557986

Locations
Turkey
Cukurova University
Adana, Turkey
Ankara Onkoloji Hastanesi
Ankara, Turkey
Adnan Menderes University
Aydin, Turkey, 09100
Izzet Baysal University
Bolu, Turkey
Istanbul University Medical faculty
Istanbul, Turkey
Marmara Univesity School of Medicine
Istanbul, Turkey
Cumhuriyet University Medical School
Sivas, Turkey
Sponsors and Collaborators
Federation of Breast Diseases Societies
Istanbul University
Abant Izzet Baysal University
Marmara University
Investigators
Study Chair: Atilla Soran, MD, MPH University of Pittsburgh
Principal Investigator: Atilla Soran, MD, MPH University of Pittsburgh
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Federation of Breast Diseases Societies
ClinicalTrials.gov Identifier: NCT00557986     History of Changes
Other Study ID Numbers: MF07-01
Study First Received: November 13, 2007
Last Updated: December 4, 2012
Health Authority: Turkey: Ministry of Health
Turkey: Ethics Committee

Keywords provided by Federation of Breast Diseases Societies:
1-Metastatic breast cancer
2-Surgery
3-Survival

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 01, 2014