Local Surgery for Metastatic Breast Cancer
10. august 2016 opdateret af: Federation of Breast Diseases Societies
The Effect of Primary Surgical Treatment on Survival in Patients With Metastatic Breast Cancer at Diagnosis
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
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
281
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Adana, Kalkun
- Cukurova University
-
Ankara, Kalkun
- Ankara Onkoloji Hastanesi
-
Aydin, Kalkun, 09100
- Adnan Menderes University
-
Bolu, Kalkun
- Izzet Baysal University
-
Istanbul, Kalkun
- Istanbul University Medical Faculty
-
Istanbul, Kalkun
- Marmara Univesity School of Medicine
-
Sivas, Kalkun
- Cumhuriyet University Medical School
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: A
Standard Systemic Therapy only group (no primary surgery)
|
|
|
Andet: B
Surgery group
|
Primary breast surgery before systemic therapy
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Measure: all cause mortality
Tidsramme: 5 years
|
5 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Quality of life
Tidsramme: 5 year
|
5 year
|
|
mordities
Tidsramme: 5 years
|
5 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: Atilla Soran, MD, MPH, University of Pittsburgh
- Ledende efterforsker: Atilla Soran, MD, MPH, University of Pittsburgh
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2007
Primær færdiggørelse (Faktiske)
1. november 2012
Studieafslutning (Faktiske)
1. november 2012
Datoer for studieregistrering
Først indsendt
13. november 2007
Først indsendt, der opfyldte QC-kriterier
13. november 2007
Først opslået (Skøn)
14. november 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
12. august 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. august 2016
Sidst verificeret
1. august 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MF07-01
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .