Local Surgery for Metastatic Breast Cancer

NCT00557986 | Completed DMC

• 1 other identifier: MF07-01
• Study Type: interventional
• Target: 281
• Locations: 1 country
• Sites: 7

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

Conditions

Breast Cancer

Keywords

1-Metastatic breast cancer; 2-Surgery; 3-Survival

Outcome Measures

Primary Outcomes (1)

• Measure: all cause mortality

  5 years

Secondary Outcomes (2)

• Quality of life

  5 year

• mordities

  5 years

Study Arms (2)

A

NO INTERVENTION

Standard Systemic Therapy only group (no primary surgery)

B

OTHER

Surgery group

Procedure: Primary surgery

Interventions

Primary surgery PROCEDURE

Primary breast surgery before systemic therapy

B

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with metastatic breast cancer at the initial diagnosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Federation of Breast Diseases Societies: lead
• Istanbul University: collaborator
• Abant Izzet Baysal University: collaborator
• Marmara University: collaborator

Study Sites (7)

Cukurova University

Adana, Turkey (Türkiye)

Location

Ankara Onkoloji Hastanesi

Ankara, Turkey (Türkiye)

Location

Adnan Menderes University

Aydin, 09100, Turkey (Türkiye)

Location

Izzet Baysal University

Bolu, Turkey (Türkiye)

Location

Istanbul University Medical faculty

Istanbul, Turkey (Türkiye)

Location

Marmara Univesity School of Medicine

Istanbul, Turkey (Türkiye)

Location

Cumhuriyet University Medical School

Sivas, Turkey (Türkiye)

Location

Related Publications (6)

• 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. doi: 10.1200/JCO.2005.04.2226. Epub 2006 May 15.

  PMID: 16702580 BACKGROUND

• 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. doi: 10.1245/ASO.2006.03.033. Epub 2006 Apr 17.

  PMID: 16614878 BACKGROUND

• Soran A, Ozmen V, Ozbas S, Karanlik H, Muslumanoglu M, Igci A, Canturk NZ, Utkan Z, Evrensel T, Sezgin E; MF07-01 Study Group. Primary Surgery with Systemic Therapy in Patients with de Novo Stage IV Breast Cancer: 10-year Follow-up; Protocol MF07-01 Randomized Clinical Trial. J Am Coll Surg. 2021 Dec;233(6):742-751.e5. doi: 10.1016/j.jamcollsurg.2021.08.686. Epub 2021 Sep 13.

  PMID: 34530124 DERIVED

• 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. 2021 Jul;29(7):3823-3830. doi: 10.1007/s00520-020-05905-z. Epub 2020 Nov 26.

  PMID: 33242163 DERIVED

• 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, Yildirim 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.

  PMID: 29777404 DERIVED

• 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.

  PMID: 19496782 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Atilla Soran, MD, MPH

  University of Pittsburgh

  STUDY CHAIR

• Atilla Soran, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2007
• First Posted: November 14, 2007
• Study Start: November 1, 2007
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: August 12, 2016

Record last verified: 2016-08

Locations

TU (7)