Breast Cancer
Conditions
Brief summary
Sentinel lymph node biopsy（SLNB） is an established way of predicting axillary nodal metastasis in early breast cancer. We aim to determinethe，in a prospective randomized, controlled trial, effect of sentinel lymph node biopsy with para-sentinel lymph node(SLN) dissection versus sentinel lymph node biopsy without para-sentinel lymph node dissection on outcomes after breast surgery.
Detailed description
Aim: Compare the disease-free survival (DFS) and overall survival (OS) of breast cancer patients who are randomized to receive sentinel lymph node biopsy with para-sentinel lymph node dissection group vs. those receive only sentinel lymph node biopsy without para-sentinel lymph node dissection Outline: Patients are randomized assigned to the following one of two groups and are followed annually. Arm I: Patients receive sentinel lymph node biopsy with para-sentinel lymph node dissection Arm II: Patients receive only sentinel lymph node biopsy without para-sentinel lymph node dissection
Interventions
PROCEDUREPatients receive SLNB
Patients receive sentinel lymph node biopsy
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. histologically confirmed primary breast cancer by core needle biopsy or excisional biopsy 2. abnormal para-sentinel lymph node was found by ultrasound examination 3. ultrasound-guided fine needle aspiration cytology of these nodes were performed 4. the result of fine needle aspiration cytology was negative (no tumour cell was found) 5. patient planed to perform SLNB
Exclusion criteria
1. pathological diagnosed ductal carcinoma in situ by excisional biopsy 2. the result of fine needle aspiration cytology was positive 3. patient has received neo-adjuvant system therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | Up to 10 years | Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first, assessed up to 10 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Up to 10 years | Time from randomization to death from any cause, assessed up to 10 years. |
Countries
China
Contacts
Primary ContactQifeng Yang, Professor
Backup ContactXiaoyan Li, Resident
Outcome results
None listed