Status:
UNKNOWN
The Benefit of Surgery in Stage IV of Breast Cancer
Lead Sponsor:
Tehran University of Medical Sciences
Conditions:
Breast Cancer Stage IV
Eligibility:
FEMALE
18-90 years
Phase:
NA
Brief Summary
Treatment of Metastatic Breast Cancer is not usually considered curative. Recent retrospective studies have demonstrated that resection of the breast tumor in patients with primary metastatic breast c...
Detailed Description
After the diagnosis of primary distant metastatic breast cancer, patients will be randomly allocated into two groups: A. systemic therapy followed by surgery if the disease is not progressive; B. Syst...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Primary confirmed distant metastatic breast cancer (M1); A histologically proven diagnosis of the breast tumor; A known hormonal and HER2Neu status; Having TNM classification: T1-T3, resectable T4 status, and N0-N3; - performance status and comorbidity should allow surgery and/or systemic therapy; Accepting the surgery by written informed consent.
- Exclusion criteria are:
- No confirmed primary invasive breast cancer in the medical history Having another malignancy within the last 10 years, besides basal cell carcinoma of the skin or early-stage cervical cancer Having the history of surgical treatment and/or radiotherapy of the breast tumor before randomization Having irresectable T4 breast tumor Having synchronous bilateral breast cancer.
- \-
Exclusion
Key Trial Info
Start Date :
November 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2021
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT04697043
Start Date
November 20 2020
End Date
December 20 2021
Last Update
January 6 2021
Active Locations (1)
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1
Tehran University of Medical Sciences
Tehran, Iran, 1136746911