Avoid axillary Sentinel Lymph node biopsy After Neoadjuvant chemotherapy Trial
- Conditions
- Neoplasms
- Registration Number
- KCT0006371
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 178
1) undergone neoadjuvant chemotherapy
2) HER-2 or triple negative breast cancer
3) clinical stage T1-3, N0-1, M0 (AJCC 8th)
4) not Inflammatory breast cancer
5) neoadjuvant chemotherapy should be done before surgery(sandwich method is not allowed)
- least four times anthacycline or taxane-based regimens
- no axilla lesion progression during chemotherapy
- no period of adverse response during chemotherapy
6) undergone anti HER-2 therapy in HER-2 positive patient
7) no preoperative anti hormonal therapy
8) no preoperative radiation therapy?
9) did not axillary lymph node biopsy before neoadjuvant chemotherapy
10) physical examination expected complete remission. And radiological expected Tumor size = 2cm or non-mass enhancement = 4cm
11) no previous axilla surgery
12) no previous ipsilateral breast surgery for invasive cancer
13) no Pregnancy-associated breast cancer
14) ECOG performance status 0-1
15) Serum or urine b-HCG negative
16) agree to the consent form
17) 20=Age<70
1) During pregnancy
2) major depression or taking psychiatric medication
3) significant psychiatric disorder or history of taking antipsychotic drugs
4) any other lymph node metastasis than axillary lesion
5) undergoing total mastectomy
6) do not agree to the consent form
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method to evaluate 5 year recurrence free survival
- Secondary Outcome Measures
Name Time Method Quality-of-life;overall survival;local recurrence-free survival ;Breast cancer specific survival;ipsilateral breast tumor recurrence interva; ipsilateral axillary recurrence interva;Adverse Event