Breast CancerASLANNCT04993625
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
A study testing avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy in people with Breast Cancer, run by Jeong Eon Lee at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 69 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Sep 2021to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 20Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
- Conditions
- Breast Cancer
- Being tested
- avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy
- Keywords
- ASLAN
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy | Experimental | Not described Receives: Procedure: avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5-year after last patient enrollment
Secondary outcomes (8)
LRFS
5-year local recurrence-free survival
Measured: 5-year after last patient enrollment
CSS
5-year cancer-specific survival
Measured: 5-year after last patient enrollment
OS
5-year overall survival
Measured: 5-year after last patient enrollment
IBTR
5-year ipsilateral breast tumor recurrence interval
Measured: 5-year after last patient enrollment
IARI
5-year ipsilateral axillary recurrence interval
Measured: 5-year after last patient enrollment
toxicity rate
5-year cumulative toxicity rate
Measured: 5-year after last patient enrollment
EORTC QLQ
5-year quality of life
Measured: 5-year after last patient enrollment
Adverse Event
5-year quality of life
Measured: 5-year after last patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start27 Sep 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeong Eon Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital, Severance Hospital, Gangnam Severance Hospital, Asan Medical Center
- Responsible party
- Sponsor-investigator, Jeong Eon Lee, Samsung Medical Center
- Investigators
- Jeong Eon Lee, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993625
- Sponsor's protocol ID
- SMC 2021-02-102
- Acronym
- ASLAN
- Status last verified
- Jan 2024
- First submitted
- 7 Jul 2021
- Last updated
- 26 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ryu JM, Lee H, Han W, Lee HB, Ahn SG, Kim HJ, Park HS, Choi JS, Kim H, Cho WK, Lee JE. Selective Avoidance of Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Human Epidermal Growth Factor 2-Positive/Triple-Negative Breast Cancer Patients With Excellent Response. J Breast Cancer. 2024 Apr;27(2):130-140. doi: 10.4048/jbc.2023.0264.
PubMed 38685868
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04993625
- Acronym / sponsor ID
- ASLAN / SMC 2021-02-102
- Conditions
- Breast Cancer
- Keywords
- ASLAN
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Jeong Eon LeeUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, Severance Hospital, Gangnam Severance Hospital, Asan Medical Center
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy | Experimental | Procedure: avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapySelective 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 | Procedure or surgery | Avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy |
Primary outcome
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.
8 secondary outcomes
LRFS
Time frame: 5-year after last patient enrollment
CSS
Time frame: 5-year after last patient enrollment
OS
Time frame: 5-year after last patient enrollment
IBTR
Time frame: 5-year after last patient enrollment
IARI
Time frame: 5-year after last patient enrollment
toxicity rate
Time frame: 5-year after last patient enrollment
EORTC QLQ
Time frame: 5-year after last patient enrollment
Adverse Event
Time frame: 5-year after last patient enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Derived from this study: PubMed 38685868Ryu JM, Lee H, Han W, Lee HB, Ahn SG, Kim HJ, Park HS, Choi JS, Kim H, Cho WK, Lee JE. Selective Avoidance of Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Human Epidermal Growth Factor 2-Positive/Triple-Negative Breast Cancer Patients With Excellent Response. J Breast Cancer. 2024 Apr;27(2):130-140. doi: 10.4048/jbc.2023.0264.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong Eon Lee, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy in people with Breast Cancer, run by Jeong Eon Lee at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year recurrence free survival (time frame: 5-year after last patient enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04993625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024; AzTrials last refreshed its copy on 1 Nov 2026.