The Effect of Primary Surgical Treatment on Survival in Patients With Metastatic Breast Cancer at Diagnosis
N/A
N/A
Female
Breast Cancer
Trial Information
The Effect of Primary Surgical Treatment on Survival in Patients With Metastatic Breast Cancer at Diagnosis
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Measure: all cause mortality
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Atilla Soran, MD, MPH
Investigator Role:
Study Chair
Investigator Affiliation:
University of Pittsburgh
Authority:
Turkey: Ministry of Health
Study ID:
MF07-01
NCT ID:
NCT00557986
Start Date:
November 2007
Completion Date:
November 2012
Related Keywords:
- Breast Cancer
- 1-Metastatic breast cancer
- 2-Surgery
- 3-Survival
- Breast Neoplasms
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