Local Surgery for Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00557986
- Lead Sponsor
- Federation of Breast Diseases Societies
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 281
- Women with metastatic breast cancer at the initial diagnosis
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Measure: all cause mortality 5 years
- Secondary Outcome Measures
Name Time Method mordities 5 years Quality of life 5 year
Trial Locations
- Locations (7)
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, Turkey
Cukurova University🇹🇷Adana, Turkey