Breast CancerASICSNCT04225858
Avoiding Sentinel Lymph Node Biopsy in Breast Cancer Patients After Neoadjuvant Chemotherapy
A study testing Omission of sentinel lymph node biopsy in people with Breast Cancer and Triple Negative Breast Cancer, run by The Netherlands Cancer Institute.
Trial summary
This study evaluates whether SLNB can safely be omitted in breast cancer patients with HER2+ or TN tumors who achieve a radiological complete response on MRI after neoadjuvant systemic therapy Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Triple Negative Breast Cancer, HER2-positive Breast Cancer
- What is being tested?
- Omission of sentinel lymph node biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Jul 2027
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women, aged ≥ 18 years
- Invasive HER2+ (HR+/-) or TN breast cancer
- Primary tumor (T), clinical stage T1-3
- Neoadjuvant systemic therapy (NST), at least 3 cycles
- Tumor stage assessed with breast MRI before start NST
- Clinically node-negative before start NST (no suspect ALNs on ultrasound and FGD-PET/CT, or negative cyto-/histopathology in case of suspect nodes)
- MRI after or during NST shows radiologic complete response
- Written and signed informed consent
Who cannot join
- Primary tumor (T) clinical stage T4
- Patients without ultrasound or FDG-PET/CT pre-NST
- History of breast cancer ipsilateral breast
- Synchronous contralateral breast cancer
- Synchronous M1 disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Avoiding Sentinel Lymph Node Biopsy In Select Clinical Node Negative Breast Cancer Patients After Neoadjuvant Systemic Therapy: the ASICS Trial
This study evaluates whether SLNB can safely be omitted in breast cancer patients with HER2+ or TN tumors who achieve a radiological complete response on MRI after neoadjuvant systemic therapy
Read the detailed description
Axillary staging in clinically node negative (cN0) breast cancer patients with neoadjuvant systemic therapy (NST; i.e. chemo- and immunotherapy), is preferably performed with sentinel lymph node biopsy (SLNB) after NST. The probability of a tumor-positive SLNB post-NST is low. cN0 patients with Human Epidermal growth factor Receptor 2- positive (HER2+) or triple negative (TN) breast cancer who achieve radiologic complete response (rCR) of the breast on MRI, have the lowest probability of a tumor-positive SLNB post-NST (<3%). Omitting removal of axillary lymph nodes in clinically node negative patients does not increase the rate of distant metastases nor breast cancer mortality. Performing SLNB can cause short- and long-term morbidity, reducing quality of life. The additional value of performing SLNB in patients with a very low risk of tumor-positive axillary lymph nodes should be investigated.
- Conditions
- Breast Cancer, Triple Negative Breast Cancer, HER2-positive Breast Cancer, Sentinel Lymph Node
- Being tested
- Omission of sentinel lymph node biopsy
- Keywords
- Neoadjuvant Chemotherapy, Sentinel lymph node biopsy, Breast cancer, Complete response
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omission of sentinel lymph node biopsyProcedure or surgery
Also called Quality of life assessment
No sentinel lymph node biopsy will be performed in clinically node-negative triple-negative or HER2-positive breast cancer patients with a radiologic complete response on MRI. Participants will be asked to complete quality of life questionnaires at baseline (prior to surgery), 6 months, 1, 3 and 5 years follow-up. A control group consisting of 100 clinically node-negative patients receiving standard treatment will be used to compare QoL scores. This group consists of patients that do not wish to participate in the experimental group (i.e., no sentinel node lymph node biopsy) or patients that are not eligible.
| Study group | Role | What they receive |
|---|---|---|
| Omission of sentinel lymph node biopsy | Experimental | No surgical axillary staging (i.e. sentinel lymph node biopsy) will be performed. Receives: Procedure: Omission of sentinel lymph node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axillary recurrence
To show that sentinel lymph node biopsy after neoadjuvant systemic therapy can be omitted in clinically node-negative HER2+ or TN breast cancer patients who achieve radiological complete response on MRI without compromising the 5 - year axillary recurrence rate (i.e, < 6% axillary recurrences within 5 years).
Measured: at 5 years
Secondary outcomes (5)
Breast cancer specific quality of life
To compare study participants in whom sentinel lymph node biopsy is omitted to patients with sentinel lymph node biopsy on breast cancer related quality of life, especially axillary morbidity score. This is measured with the EORTC-BR23 scale. The arm morbidity score consists of 3 items, points ranging from 1 - 4 per item. A higher score indicates more morbidity.
Measured: at 5 years
Level of cancer worry
To compare study participants in whom sentinel lymph node biopsy is omitted to patients with sentinel lymph node biopsy on level of cancer worry, using the cancer worry scale (CWS). The CWS consists of 8 items, with 1-4 points per item and a maximum score of 32 points. Higher scores indicate more frequent cancer worry.
Measured: at 5 years
Recurrence-free survival
To assess 5-year recurrence-free survival in clinically node-negative HER2+ or TN patients with radiologic complete response on MRI in whom sentinel lymph node biopsy is omitted.
Measured: at 5 years
Overall survival
To assess 5-year overall survival in clinically node-negative HER2+ or TN patients with radiologic complete response on MRI in whom sentinel lymph node biopsy is omitted.
Measured: at 5 years
Disease-specific survival
To assess 5-year disease specific survival in clinically node-negative HER2+ or TN patients with radiologic complete response on MRI in whom sentinel lymph node biopsy is omitted.
Measured: at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study startJan 2020 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Prospective non-inferiority cohort, single-arm registration trial
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Jeanne T.F.D. Vrancken Peeters, MD, PhD, Principal investigator, Antoni van Leeuwenhoek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225858
- Sponsor's protocol ID
- N19ASC
- Acronym
- ASICS
- Status last verified
- Jan 2020
- First submitted
- 4 Dec 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avoiding Sentinel Lymph Node Biopsy In Select Clinical Node Negative Breast Cancer Patients After Neoadjuvant Systemic Therapy: the ASICS Trial
- ClinicalTrials.gov ID
- NCT04225858
- Acronym / sponsor ID
- ASICS / N19ASC
- Conditions
- Breast Cancer, Triple Negative Breast Cancer, HER2-positive Breast Cancer, Sentinel Lymph Node
- Keywords
- Neoadjuvant Chemotherapy, Sentinel lymph node biopsy, Breast cancer, Complete response
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 13 Jan 2020 (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.
This study evaluates whether SLNB can safely be omitted in breast cancer patients with HER2+ or TN tumors who achieve a radiological complete response on MRI after neoadjuvant systemic therapy
Detailed description
Axillary staging in clinically node negative (cN0) breast cancer patients with neoadjuvant systemic therapy (NST; i.e. chemo- and immunotherapy), is preferably performed with sentinel lymph node biopsy (SLNB) after NST. The probability of a tumor-positive SLNB post-NST is low. cN0 patients with Human Epidermal growth factor Receptor 2- positive (HER2+) or triple negative (TN) breast cancer who achieve radiologic complete response (rCR) of the breast on MRI, have the lowest probability of a tumor-positive SLNB post-NST (<3%). Omitting removal of axillary lymph nodes in clinically node negative patients does not increase the rate of distant metastases nor breast cancer mortality. Performing SLNB can cause short- and long-term morbidity, reducing quality of life. The additional value of performing SLNB in patients with a very low risk of tumor-positive axillary lymph nodes should be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective non-inferiority cohort, single-arm registration trial
| Arm | Type | Receives |
|---|---|---|
| Omission of sentinel lymph node biopsy | Experimental | Procedure: Omission of sentinel lymph node biopsyNo surgical axillary staging (i.e. sentinel lymph node biopsy) will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women, aged ≥ 18 years
- Invasive HER2+ (HR+/-) or TN breast cancer
- Primary tumor (T), clinical stage T1-3
- Neoadjuvant systemic therapy (NST), at least 3 cycles
- Tumor stage assessed with breast MRI before start NST
Key exclusion criteria (5 listed)
- Primary tumor (T) clinical stage T4
- Patients without ultrasound or FDG-PET/CT pre-NST
- History of breast cancer ipsilateral breast
- Synchronous contralateral breast cancer
- Synchronous M1 disease
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 |
|---|---|---|
| Omission of sentinel lymph node biopsyAlso: Quality of life assessmentNo sentinel lymph node biopsy will be performed in clinically node-negative triple-negative or HER2-positive breast cancer patients with a radiologic complete response on MRI. Participants will be asked to complete quality of life questionnaires at baseline (prior to surgery), 6 months, 1, 3 and 5 years follow-up. A control group consisting of 100 clinically node-negative patients receiving standard treatment will be used to compare QoL scores. This group consists of patients that do not wish to participate in the experimental group (i.e., no sentinel node lymph node biopsy) or patients that are not eligible. | Procedure or surgery | Omission of sentinel lymph node biopsy |
Primary outcome
Axillary recurrence
Time frame: at 5 years
To show that sentinel lymph node biopsy after neoadjuvant systemic therapy can be omitted in clinically node-negative HER2+ or TN breast cancer patients who achieve radiological complete response on MRI without compromising the 5 - year axillary recurrence rate (i.e, < 6% axillary recurrences within 5 years).
5 secondary outcomes
Breast cancer specific quality of life
Time frame: at 5 years
Level of cancer worry
Time frame: at 5 years
Recurrence-free survival
Time frame: at 5 years
Overall survival
Time frame: at 5 years
Disease-specific survival
Time frame: at 5 years
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 13 Jan 2020.
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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.
Marie-Jeanne T.F.D. Vrancken Peeters, MD, PhD principal investigator
Antoni van Leeuwenhoek
Questions about this trial
What is this clinical trial studying?
A study testing Omission of sentinel lymph node biopsy in people with Breast Cancer and Triple Negative Breast Cancer, run by The Netherlands Cancer Institute.
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 8 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Marie-Jeanne T.F.D. Vrancken Peeters, MD, PhD (+3120512 ext. 2978, m.vrancken@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axillary recurrence (time frame: at 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2020; AzTrials last refreshed its copy on 26 Oct 2026.