Avoid axillary Sentinel Lymph node biopsy After Neoadjuvant chemotherapy Trial

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, prospective, multi-center, single-arm study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006371

Enrollment

178

Registered

2021-07-22

Start date

2021-09-27

Completion date

Unknown

Last updated

2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Omit sentinel lymph node biopsy after neoadjuvant chemotherapy in triple negative or HER-2 positive breast cancer patients

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

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
to evaluate 5 year recurrence free survival	—

Secondary

Measure	Time frame
Quality-of-life;overall survival;local recurrence-free survival ;Breast cancer specific survival;ipsilateral breast tumor recurrence interva; ipsilateral axillary recurrence interva;Adverse Event	—

Countries

Korea, Republic of

Contacts

Public ContactRaejin Lee

Samsung Medical Center

raejin.lee@samsung.com+82-70-7014-4154

Outcome results