Breast Cancer
Conditions
Keywords
ASLAN
Brief summary
The aims of this study is to evaluate 5 year recurrence free survival when omit sentinel lymph node biopsy after neoadjuvant chemotherapy in triple negative or HER-2 positive breast cancer patients when physical examination expected complete remission. And radiological expected Tumor size ≤ 2cm or non-mass enhancement ≤ 4cm.
Interventions
PROCEDUREavoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy
Selective Omission of Sentinel Lymph Node Biopsy after Neoadjuvant Chemotherapy In HER-2 positive/Triple Negative Breast Cancer Patients with Excellent Radiologic Response to the Breast and Axilla
Sponsors
Seoul National University Hospital
Severance Hospital
Gangnam Severance Hospital
Asan Medical Center
Jeong Eon Lee
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
1. 20≤Age\<70 2. undergone neoadjuvant chemotherapy 3. HER-2 or triple negative breast cancer 4. clinical stage T1-3, N0-1, M0 (AJCC 8th) 5. not Inflammatory breast cancer 6. 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 7. undergone anti HER-2 therapy in HER-2 positive patient 8. no preoperative anti hormonal therapy 9. no preoperative radiation therapy 10. did not axillary lymph node biopsy before neoadjuvant chemotherapy 11. physical examination expected complete remission. And radiological expected Tumor size ≤ 2cm or non-mass enhancement ≤ 4cm 12. no previous axilla surgery 13. no previous ipsilateral breast surgery for invasive cancer 14. no Pregnancy-associated breast cancer 15. ECOG performance status 0-1 16. Serum or urine b-HCG negative 17. agree to the consent form
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year recurrence free survival | 5-year after last patient enrollment | The aims of this study is to evaluate 5 year recurrence free survival when omit sentinel lymph node biopsy after neoadjuvant chemotherapy in triple negative or HER-2 positive breast cancer patients when expected complete remission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CSS | 5-year after last patient enrollment | 5-year cancer-specific survival |
| OS | 5-year after last patient enrollment | 5-year overall survival |
| IBTR | 5-year after last patient enrollment | 5-year ipsilateral breast tumor recurrence interval |
| LRFS | 5-year after last patient enrollment | 5-year local recurrence-free survival |
| toxicity rate | 5-year after last patient enrollment | 5-year cumulative toxicity rate |
| EORTC QLQ | 5-year after last patient enrollment | 5-year quality of life |
| Adverse Event | 5-year after last patient enrollment | 5-year quality of life |
| IARI | 5-year after last patient enrollment | 5-year ipsilateral axillary recurrence interval |
Countries
South Korea
Outcome results
None listed