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

Study Description

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 Design

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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 Genetics related topics: Breast cancer

MedlinePlus related topics: Breast Cancer

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

Quality of life [ Time Frame: 5 year ]
mordities [ Time Frame: 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Older Adult
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

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): NCT00557986

Locations

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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

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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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Soran A, Soyder A, Ozbas S, Ozmen V, Karanlik H, Igci A, Muslumanoglu M, Evrensel T, Canturk Z, Utkan Z, Ozaslan C, Uras C, Ugurlu U, Col C, Cabioglu N, Uzunkoy A, Gulluoglu BM, Erdem E, Konca C, Sezgin E; Breast Health Working Group International (supported by the Turkish Federation of Breast Disease Societies). The role of loco-regional treatment in long-term quality of life in de novo stage IV breast cancer patients: protocol MF07-01Q. Support Care Cancer. 2020 Nov 26. doi: 10.1007/s00520-020-05905-z. [Epub ahead of print]

Soran A, Ozmen V, Ozbas S, Karanlik H, Muslumanoglu M, Igci A, Canturk Z, Utkan Z, Ozaslan C, Evrensel T, Uras C, Aksaz E, Soyder A, Ugurlu U, Col C, Cabioglu N, Bozkurt B, Uzunkoy A, Koksal N, Gulluoglu BM, Unal B, Atalay C, Yıldırım E, Erdem E, Salimoglu S, Sezer A, Koyuncu A, Gurleyik G, Alagol H, Ulufi N, Berberoglu U, Dulger M, Cengiz O, Sezgin E, Johnson R. Randomized Trial Comparing Resection of Primary Tumor with No Surgery in Stage IV Breast Cancer at Presentation: Protocol MF07-01. Ann Surg Oncol. 2018 Oct;25(11):3141-3149. doi: 10.1245/s10434-018-6494-6. Epub 2018 May 17.

Soran A, Ozbas S, Kelsey SF, Gulluoglu BM. Randomized trial comparing locoregional resection of primary tumor with no surgery in stage IV breast cancer at the presentation (Protocol MF07-01): a study of Turkish Federation of the National Societies for Breast Diseases. Breast J. 2009 Jul-Aug;15(4):399-403. doi: 10.1111/j.1524-4741.2009.00744.x. Epub 2009 May 22.

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Responsible Party:	Federation of Breast Diseases Societies
ClinicalTrials.gov Identifier:	NCT00557986
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:

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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases

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