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Local Surgery for Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00557986
Recruitment Status : Completed
First Posted : November 14, 2007
Last Update Posted : August 12, 2016
Sponsor:
Collaborators:
Istanbul University
Abant Izzet Baysal University
Marmara University
Information provided by (Responsible Party):
Federation of Breast Diseases Societies

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Procedure: Primary surgery Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Primary Surgical Treatment on Survival in Patients With Metastatic Breast Cancer at Diagnosis
Study Start Date : November 2007
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: A
Standard Systemic Therapy only group (no primary surgery)
B
Surgery group
Procedure: Primary surgery
Primary breast surgery before systemic therapy



Primary Outcome Measures :
  1. Measure: all cause mortality [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 5 year ]
  2. mordities [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

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): 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

Publications:
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
First Posted: November 14, 2007    Key Record Dates
Last Update Posted: August 12, 2016
Last Verified: August 2016

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