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

Breast Cancer Clinical Trial

— ASLAN  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04993625
• Other study ID #: SMC 2021-02-102
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 27, 2021
• Est. completion date: December 31, 2028

Study information

• Verified date: January 2024
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 178
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Neoplasms

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (5)

Lead Sponsor	Collaborator
Jeong Eon Lee	Asan Medical Center, Gangnam Severance Hospital, Seoul National University Hospital, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year recurrence free survival	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.	5-year after last patient enrollment
Secondary	LRFS	5-year local recurrence-free survival	5-year after last patient enrollment
Secondary	CSS	5-year cancer-specific survival	5-year after last patient enrollment
Secondary	OS	5-year overall survival	5-year after last patient enrollment
Secondary	IBTR	5-year ipsilateral breast tumor recurrence interval	5-year after last patient enrollment
Secondary	IARI	5-year ipsilateral axillary recurrence interval	5-year after last patient enrollment
Secondary	toxicity rate	5-year cumulative toxicity rate	5-year after last patient enrollment
Secondary	EORTC QLQ	5-year quality of life	5-year after last patient enrollment
Secondary	Adverse Event	5-year quality of life	5-year after last patient enrollment