Status:
WITHDRAWN
Axillary Lymph Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node
Lead Sponsor:
Shandong Cancer Hospital and Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
The recently randomized trial (ASCOG Z0011) support that among patients with limited sentinel lymph node (SLN) metastatic breast cancer treated with breast conservation and systemic therapy, the use o...
Detailed Description
OBJECTIVES: To determine the effects of complete axillary lymph node dissection (ALND) on survival of patients with sentinel lymph node (SLN) metastasis of breast cancer. OUTLINE: This is a randomiz...
Eligibility Criteria
Inclusion
- Female;
- Patient aged 18 years and above;
- Patient with histological proven invasive breast cancer;
- Clinical T1-T2 disease with no distant metastasis;
- Patient with clinical N0 status;
- Patient for whom conservative surgery with sentinel lymph node (SLN) technique is feasible from the start in terms of carcinologic;
- Patient with positive SLNs 1\~2;
- Signed consent to participate.
Exclusion
- History of neoadjuvant chemotherapy or hormone therapy;
- History of breast cancer (ipsilateral, i.e. recurrence, or contralateral breast);
- History of any other invasive cancer;
- Initial metastatic disease known;
- Pregnant women or lactating women;
- Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01796444
Start Date
January 1 2013
End Date
June 1 2026
Last Update
April 5 2018
Active Locations (1)
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1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 250117