Local Surgery for Metastatic Breast Cancer

Conditions

Breast Cancer

Keywords

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

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

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.

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).

2020-11-2611 citations

10.1007/s00520-020-05905-z

Abstract P1-20-01: Primary surgery in patients with de novo stage IV BC; finalizing the protocol MF07-01 randomized clinical trial

Atilla Soran, Vahit Özmen, Serdar Özbaş, Hasan Karanlık, Mahmut Müslümanoğlu et al. (19 authors)

Cancer Research2020-02-152 citations

10.1158/1538-7445.sabcs19-p1-20-01

A randomized controlled trial evaluating resection of the primary breast tumor in women presenting with de novo stage IV breast cancer: Turkish Study (Protocol MF07-01).

Atilla Soran, Vahit Özmen, Serdar Özbaş, Hasan Karanlık, Mahmut Müslümanoğlu et al. (20 authors)

Journal of Clinical Oncology2016-05-2065 citations

10.1200/jco.2016.34.15_suppl.1005

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.

Soran A, Ozbas S, Kelsey SF, Gulluoglu BM.

2009-05-2245 citations

10.1111/j.1524-4741.2009.00744.x

Interventions

PROCEDUREPrimary surgery

Primary breast surgery before systemic therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Measure: all cause mortality	5 years

Secondary

Measure	Time frame
Quality of life	5 year
mordities	5 years

Countries

Turkey (Türkiye)

Outcome results

None listed