The Benefit of Surgery in Stage IV of Breast Cancer
Breast Cancer Stage IV
About this trial
This is an interventional treatment trial for Breast Cancer Stage IV focused on measuring Surgery, Breast Cancer, Stage IV
Eligibility Criteria
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.
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Sites / Locations
- Tehran University of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
systemic therapy followed by surgery
Systemic therapy
ُThe main intervention is surgery. 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. Systemic therapy Patient selection criteria The eligibility criteria for the study are: - primary distant metastatic breast cancer (M1); - an anticipated survival of at least 6 months; - a histologically proven diagnosis of the breast tumor; - a known hormonal and HER2Neu status; - TNM classification: T1-T3, resectable T4 status, and N0-N3; - performance status and comorbidity should allow surgery and/or systemic therapy; - age ≥ 18 years;- written informed consent.
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. Systemic therapy Patient selection criteria The eligibility criteria for the study are: - primary distant metastatic breast cancer (M1); - an anticipated survival of at least 6 months; - a histologically proven diagnosis of the breast tumor; - a known hormonal and HER2Neu status; - TNM classification: T1-T3, resectable T4 status, and N0-N3; - performance status and comorbidity should allow surgery and/or systemic therapy; - age ≥ 18 years;- written informed consent.