Clinical trial NCT04993625: 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
Official title: Selective Avoidanve 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: ASLAN
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
name: Severance Hospital
name: Gangnam Severance Hospital
name: Asan Medical Center
First posted: 2021-08-06
Enrollment: 178
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 5-year recurrence free survival
timeFrame: 5-year after last patient enrollment
Secondary outcomes:
measure: LRFS
timeFrame: 5-year after last patient enrollment
measure: CSS
timeFrame: 5-year after last patient enrollment
measure: OS
timeFrame: 5-year after last patient enrollment
measure: IBTR
timeFrame: 5-year after last patient enrollment
measure: IARI
timeFrame: 5-year after last patient enrollment
measure: toxicity rate
timeFrame: 5-year after last patient enrollment
measure: EORTC QLQ
timeFrame: 5-year after last patient enrollment
measure: Adverse Event
timeFrame: 5-year after last patient enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jeong Eon Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: