Selective Avoidance 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, Prospective, Multi-center, Single-arm (ASLAN) Study
NCT ID: NCT04993625
Last Updated: 2024-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
178 participants
INTERVENTIONAL
2021-09-27
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy
avoid 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
Interventions
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avoid 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
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
69 Years
FEMALE
No
Sponsors
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Seoul National University Hospital
OTHER
Severance Hospital
OTHER
Gangnam Severance Hospital
OTHER
Asan Medical Center
OTHER
Jeong Eon Lee
OTHER
Responsible Party
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Jeong Eon Lee
Samsung Medical Center
Principal Investigators
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Jeong Eon Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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References
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Ryu JM, Lee H, Han W, Lee HB, Ahn SG, Kim HJ, Park HS, Choi JS, Kim H, Cho WK, Lee JE. Selective Avoidance of Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Human Epidermal Growth Factor 2-Positive/Triple-Negative Breast Cancer Patients With Excellent Response. J Breast Cancer. 2024 Apr;27(2):130-140. doi: 10.4048/jbc.2023.0264.
Other Identifiers
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SMC 2021-02-102
Identifier Type: -
Identifier Source: org_study_id
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