Active — Not RecruitingNot Applicable

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

South Korea178 participantsStarted 2021-09-27

Plain-language 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.

Who can participate

Age range20 Years – 69 Years

SexFEMALE

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Inclusion criteria

✓. 20≤Age\<70
✓. undergone neoadjuvant chemotherapy
✓. HER-2 or triple negative breast cancer
✓. clinical stage T1-3, N0-1, M0 (AJCC 8th)
✓. not Inflammatory breast cancer
✓. neoadjuvant chemotherapy should be done before surgery(sandwich method is not allowed)
✓. undergone anti HER-2 therapy in HER-2 positive patient
✓. no preoperative anti hormonal therapy

Exclusion criteria

✕. During pregnancy
✕. major depression or taking psychiatric medication
✕. significant psychiatric disorder or history of taking antipsychotic drugs
✕. any other lymph node metastasis than axillary lesion
✕. undergoing total mastectomy
✕. do not agree to the consent form

What they're measuring

5-year recurrence free survival

Timeframe: 5-year after last patient enrollment

Trial details

NCT IDNCT04993625

SponsorJeong Eon Lee

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

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