Local Surgery for Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

The Effect of Primary Surgical Treatment on Survival in Patients With Metastatic Breast Cancer at Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00557986
• Other study ID #: MF07-01
• Status: Completed
• Phase: N/A
• First received: November 13, 2007
• Last updated: August 10, 2016
• Start date: November 2007
• Est. completion date: November 2012

Study information

• Verified date: August 2016
• Source: Federation of Breast Diseases Societies
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of HealthTurkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Primary surgery
Primary breast surgery before systemic therapy

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana
Turkey	Ankara Onkoloji Hastanesi	Ankara
Turkey	Adnan Menderes University	Aydin
Turkey	Izzet Baysal University	Bolu
Turkey	Istanbul University Medical faculty	Istanbul
Turkey	Marmara Univesity School of Medicine	Istanbul
Turkey	Cumhuriyet University Medical School	Sivas

Sponsors (4)

Lead Sponsor	Collaborator
Federation of Breast Diseases Societies	Abant Izzet Baysal University, Istanbul University, Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure: all cause mortality		5 years	No
Secondary	Quality of life		5 year	No
Secondary	mordities		5 years	No