Local Surgery for Metastatic Breast Cancer

Federation of Breast Diseases Societies

Status

Completed

Conditions

Breast Cancer

Treatments

Procedure: Primary surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT00557986

MF07-01

Details and patient eligibility

About

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

Full 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.

Enrollment

281 patients

Sex

Female

Volunteers

No Healthy Volunteers

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