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NCT Number: 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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • least four times anthacycline or taxane-based regimens
  • no axilla lesion progression during chemotherapy
  • no period of adverse response during chemotherapy
  • undergone anti HER-2 therapy in HER-2 positive patient
  • no preoperative anti hormonal therapy
  • no preoperative radiation therapy
  • did not axillary lymph node biopsy before neoadjuvant chemotherapy
  • physical examination expected complete remission. And radiological expected Tumor size ≤ 2cm or non-mass enhancement ≤ 4cm
  • no previous axilla surgery
  • no previous ipsilateral breast surgery for invasive cancer
  • no Pregnancy-associated breast cancer
  • ECOG performance status 0-1
  • Serum or urine b-HCG negative
  • agree to the consent form

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

Treatment and study plan

avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy

Procedure

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

Primary outcomes

  1. 5-year recurrence free survival

    Time frame: 5-year after last patient enrollment

    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.

Secondary outcomes

  1. LRFS

    Time frame: 5-year after last patient enrollment

    5-year local recurrence-free survival

  2. CSS

    Time frame: 5-year after last patient enrollment

    5-year cancer-specific survival

  3. OS

    Time frame: 5-year after last patient enrollment

    5-year overall survival

  4. IBTR

    Time frame: 5-year after last patient enrollment

    5-year ipsilateral breast tumor recurrence interval

  5. IARI

    Time frame: 5-year after last patient enrollment

    5-year ipsilateral axillary recurrence interval

  6. toxicity rate

    Time frame: 5-year after last patient enrollment

    5-year cumulative toxicity rate

  7. EORTC QLQ

    Time frame: 5-year after last patient enrollment

    5-year quality of life

  8. Adverse Event

    Time frame: 5-year after last patient enrollment

    5-year quality of life

Sponsors and collaborators

Lead sponsor

Jeong Eon Lee

Other

Collaborators

  • Asan Medical Center
  • Gangnam Severance Hospital
  • Seoul National University Hospital
  • Severance Hospital

Registry information

Official study 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

Acronym: ASLAN

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Aug 6, 2021
Registry last updated
Jan 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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