NCT04993625Active, not recruiting
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
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
Source: ClinicalTrials.gov · Last updated 26 Jan 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 178 (estimated)
- First submitted
- 7 Jul 2021
- Start date
- 27 Sept 2021
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Jeong Eon Lee
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT04993625
What you commit to
- Study type: Interventional
- Planned participants: 178
- From 27 Sept 2021 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- major depression or taking psychiatric medication
- significant psychiatric disorder or history of taking antipsychotic drugs
Other
- During pregnancy
- any other lymph node metastasis than axillary lesion
- undergoing total mastectomy
- do not agree to the consent form
Who the study is looking for
- 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
Age in the registry: 20 years to 69 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.