Local Surgery for Metastatic Breast Cancer - Full Text View

Sponsors and Collaborators:	Federation of Breast Diseases Societies Istanbul University
Information provided by:	Federation of Breast Diseases Societies
ClinicalTrials.gov Identifier:	NCT00557986

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

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

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

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

Primary Outcome Measures:

Measure: all cause mortality [ Time Frame: 5 years ]

Secondary Outcome Measures:

Quality of life [ Time Frame: 5 year ]

Estimated Enrollment:	271
Study Start Date:	November 2007
Estimated Study Completion Date:	October 2012

Arms	Assigned Interventions
A: Active Comparator Systemic Therapy	Procedure: Primary surgery Primary surgery

Detailed Description:

This is a prospective, randomised 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557986

Contacts

Contact: Serdar Ozbas, MD

90533 6880266

sozbas@yahoo.com

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
Cukurova University	Recruiting
Adana, Turkey
Contact: Orhan Demircan, MD odemircan@mail.cu.edu.tr
Principal Investigator: Orhan Demircan, MD
Izzet Baysal University	Recruiting
Bolu, Turkey
Contact: Cavit Col, MD cavitcol@yahoo.com
Principal Investigator: Cavit Col, MD

Sponsors and Collaborators

Federation of Breast Diseases Societies

Istanbul University

Investigators

Study Chair:	Atilla Soran, MD, MPH	University of Pittsburgh
Principal Investigator:	Atilla Soran, MD, MPH	University of Pittsburgh

More Information

Publications:

Rapiti E, Verkooijen HM, Vlastos G, Fioretta G, Neyroud-Caspar I, Sappino AP, Chappuis PO, Bouchardy C. Complete excision of primary breast tumor improves survival of patients with metastatic breast cancer at diagnosis. J Clin Oncol. 2006 Jun 20;24(18):2743-9. Epub 2006 May 15.

Babiera GV, Rao R, Feng L, Meric-Bernstam F, Kuerer HM, Singletary SE, Hunt KK, Ross MI, Gwyn KM, Feig BW, Ames FC, Hortobagyi GN. Effect of primary tumor extirpation in breast cancer patients who present with stage IV disease and an intact primary tumor. Ann Surg Oncol. 2006 Jun;13(6):776-82. Epub 2006 Apr 17.

Study ID Numbers:	MF07-01
Study First Received:	November 13, 2007
Last Updated:	November 13, 2007
ClinicalTrials.gov Identifier:	NCT00557986
Health Authority:	Turkey: Ministry of Health

Keywords provided by Federation of Breast Diseases Societies:

1-Metastatic breast cancer
2-Surgery
3-Survival

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009