Breast CancerNCT06096545
Axillary Management After Neoadjuvant Chemotherapy
A study testing Axillary sentinal lymph node biopsy in people with Breast Cancer and Breast Neoplasms, run by Medipol University at 2 sites in Turkey (Türkiye).
Trial summary
The standard treatment for locally advanced and node-positive breast cancer is surgery following neoadjuvant chemotherapy (NAC). Using NAC in advanced-stage tumors and biologically aggressive subtypes can lead to de-escalation in surgical treatment for the breast and axilla. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Breast Cancer Female
- What is being tested?
- Axillary sentinal lymph node biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 12 Mar 2024to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years-old female patients
- Clinical stage T1-3 and biopsy-proven N1 breast cancer
- Axillary nodal involvement
- Volunteer to participate in to study
Who cannot join
- A history of axillary surgery or SLNB, prior axillary excisional lymph node surgery,
- N2-3 disease with a decision for initial axillary lymph node dissection (ALND),
- Diagnosis of inflammatory breast cancer,
- Presence of distant metastasis
- Incomplete chemotherapy, pregnancy, and lactation
- T4 tumors
- Refusal to participate in to study
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Istanbul Medipol University Hospital
Istanbul, Bagcilar, 34083
Pelin Basim, As. Prof, MD, 05337186679
- Recruiting
Istanbul Gaziosmanpasa Training and Research Hospital
Istanbul, 34083
Emine Yildirim, As. Prof, MD, 05056234825
Emine YILDIRIM, As. Prof.,MD
About this study
Official title: Axillary Management After Neoadjuvant Chemotherapy: May Axillary Biopsy Replace Sentinel Lymph Node Biopsy?
The standard treatment for locally advanced and node-positive breast cancer is surgery following neoadjuvant chemotherapy (NAC). Using NAC in advanced-stage tumors and biologically aggressive subtypes can lead to de-escalation in surgical treatment for the breast and axilla.
Previously, NAC was believed to alter lymphatic drainage due to fibrosis and tumor emboli in lymphatic channels. However, the theAmerican College of Surgeons Oncology Group (ACOSOG) Z1071 and Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA) trials investigated the performance of sentinel lymph node biopsy (SLNB) after NAC in patients with proven axillary lymph node involvement at the initial biopsy.
Read more
In contemporary breast cancer management, particularly in the axillary approach, less invasive techniques are becoming increasingly common. This raises the question of whether there might be a patient group where SLNB could be avoided.
In this study, the investigators sought a new method to evaluate the axilla after NAC in patients with known axillary involvement previously. For this purpose, the investigators performed an ultrasound-guided needle biopsy on the clipped axillary lymph node with known metastasis before the planned surgery, aiming to assess the axilla without performing SLNB after treatment. Additionally, the investigators investigated which patient group might benefit more from this predictability based on molecular subtypes and clinical-pathological features.
Read the detailed description
The current study was designed as a prospective randomized clinical trial conducted at two participating centers to evaluate the predictability of sentinel lymph node biopsy (SLNB) using axillary ultrasound-guided fine-needle aspiration biopsy (FNAB) and core needle biopsy (CNB) in patients with histologically proven axillary lymph node metastasis after neoadjuvant chemotherapy (NAC). The study was initiated after obtaining approval from the local ethics committee (Dated:06.03.3023/decision no:E-10840098-772.02-1685).
Patients:
Female patients aged 18 years and above with clinical stage T1-3 and biopsy-proven N1 breast cancer who received NAC were included in the study. Exclusion criteria were a history of axillary surgery or SLNB, prior axillary excisional lymph node surgery, N2-3 disease with a decision for initial axillary lymph node dissection (ALND), diagnosis of inflammatory breast cancer, presence of distant metastasis, incomplete chemotherapy, pregnancy, and lactation.
All participants underwent breast ultrasonography, mammography, and magnetic resonance imaging for imaging before NAC. Clipped lymph nodes that were histopathologically proven to be metastatic at the time of diagnosis underwent ultrasonography-guided CNB or FNAB seven days before surgery. Histopathological results after biopsy were grouped as negative, positive, and non-diagnostic for metastasis.
Patients were randomized into two groups based on the initial biopsy method. In Group A, patients with axillary metastasis identified by FNAB were subjected to repeat ultrasound-guided FNAB after completion of neoadjuvant treatment, while in Group B, patients with axillary metastasis identified by CNB underwent repeat biopsy using the same method after completing neoadjuvant treatment.
Surgical Technique and Nodal Evaluation:
SLNB technique using isosulfan blue dye was performed for axillary evaluation, and all patients had the clipped lymph node excised under ultrasound guidance with a guide wire placed preoperatively.
Inter-group Comparison:
Sensitivity, specificity, false-negative rate (FNR), false-positive rate (FPR), and accuracy values were compared between the two groups based on the needle biopsy and SLNB performed after NAC. In patients re-evaluated with FNAB and CNB after NAC, the effects of patient age, tumor size, radiological features of breast cancer and axillary lymph node, tumor and lymph node size, histopathological type and grade of tumor, receptor characteristics, maximum standardized uptake value (SUV) of the breast and axillary lymph node on Positron Emission Tomography and Computed Tomography (PET-CT), and differences in ER, PR, Her-2, and Ki 67 receptors in the final pathology were investigated on sensitivity, specificity, FNR, FPR, and accuracy.
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Cancer Female
- Being tested
- Axillary sentinal lymph node biopsy
- Keywords
- locally advanced breast cancer, axillary involvement, neoadjuvant chemotherapy, axillary biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary sentinal lymph node biopsyProcedure or surgery
Also called Axillary dissection
For SLNB evaluation, multiple sections of the excised lymph node were stained with hematoxylin and eosin (H\&E) at a thickness greater than 2 mm. Lymph nodes with metastasis greater than 2 mm were defined as positive SLNB. Macroscopic metastasis was considered positive in the evaluation for the axilla, while benign histological characteristics were considered negative. The presence of micrometastasis and isolated tumor cells was also noted. The size and diameter of the metastatic lymph node were considered in the evaluation.
SLNB technique using isosulfan blue dye was performed for axillary evaluation, and all patients had the clipped lymph node excised under ultrasound guidance with a guide wire placed preoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 = Fine needle aspiration biopsy | Active comparator | In Group A, patients with axillary metastasis identified by FNAB were subjected to repeat ultrasound-guided FNAB after completion of neoadjuvant treatment, The obtained biopsies were sent for histopathological evaluation without revealing patient names to avoid influencing the research results, and the surgical team was not informed of the biopsy results. During surgery, both dyed lymph nodes and clipped lymph nodes were excised for SLNB and assessed by frozen section evaluation. Receives: Procedure: Axillary sentinal lymph node biopsy |
| Group 2 = Core biopsy | Active comparator | in Group B, patients with axillary metastasis identified by CNB underwent repeat biopsy using the same method after completing neoadjuvant treatment.The obtained biopsies were sent for histopathological evaluation without revealing patient names to avoid influencing the research results, and the surgical team was not informed of the biopsy results. During surgery, both dyed lymph nodes and clipped lymph nodes were excised for SLNB and assessed by frozen section evaluation. Receives: Procedure: Axillary sentinal lymph node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of axillary status after neoadjuvant chemotherapy without SLNB
In this study, the investigators sought a new method to evaluate the axilla after NAC in patients with known axillary involvement previously. For this purpose, the investigators performed an ultrasound-guided needle biopsy on the clipped axillary lymph node with known metastasis before the planned surgery, aiming to assess the axilla without performing SLNB after treatment.
Measured: through study completion, an average of 6 month
Secondary outcomes (1)
The investigators investigated which patient group might benefit more from this prediction based on molecular subtypes and the clinical-pathological features
Therefore, patient age, ultrasonographic parameters, maximum SUV of the breast and axillary lymph node on PET-CT, histopathological subtypes of breast cancer, largest tumor diameter, histopathological diagnosis, histological grade, estrogen, progesterone, Ki-67 and Her-2 receptor status will be evaluated and the effectiveness of these parameters in order to accurately assess the axillary lymph node without SLNB will be investigated.
Measured: through study completion, an average of 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start12 Mar 2024
- Primary completion30 Jun 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomized into two groups based on the initial biopsy method. In Group A, patients with axillary metastasis identified by FNAB were subjected to repeat ultrasound-guided FNAB after completion of neoadjuvant treatment, while in Group B, patients with axillary metastasis identified by CNB underwent repeat biopsy using the same method after completing neoadjuvant treatment. The obtained biopsies were sent for histopathological evaluation without revealing patient names to avoid influencing the research results, and the surgical team was not informed of the biopsy results. During surgery, both dyed lymph nodes and clipped lymph nodes were excised for SLNB and assessed by frozen section evaluation. Thus, the predictability of axillary metastasis by preoperative FNAB/CNB was tested.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pelin Basım, Medipol University
- Investigators
- Pelin Basim, As. prof, MD, Principal investigator, Medipol University / General Surgery DepartmentEmine YILDIRIM, As. prof, MD, Principal investigator, Gaziosmanpasa Training and Research Hospital / General Surgery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096545
- Sponsor's protocol ID
- Medipol Hospital 1
- Status last verified
- Mar 2024
- First submitted
- 18 Jul 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share individual participant data
Publications
You S, Kang DK, Jung YS, An YS, Jeon GS, Kim TH. Evaluation of lymph node status after neoadjuvant chemotherapy in breast cancer patients: comparison of diagnostic performance of ultrasound, MRI and (1)(8)F-FDG PET/CT. Br J Radiol. 2015 Aug;88(1052):20150143. doi: 10.1259/bjr.20150143.
PubMed 26110204Ha SM, Cha JH, Kim HH, Shin HJ, Chae EY, Choi WJ. Diagnostic performance of breast ultrasonography and MRI in the prediction of lymph node status after neoadjuvant chemotherapy for breast cancer. Acta Radiol. 2017 Oct;58(10):1198-1205. doi: 10.1177/0284185117690421. Epub 2017 Mar 28.
PubMed 28350255
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axillary Management After Neoadjuvant Chemotherapy: May Axillary Biopsy Replace Sentinel Lymph Node Biopsy?
- ClinicalTrials.gov ID
- NCT06096545
- Acronym / sponsor ID
- Medipol Hospital 1
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Cancer Female
- Keywords
- locally advanced breast cancer, axillary involvement, neoadjuvant chemotherapy, axillary biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 23 Oct 2023 (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 standard treatment for locally advanced and node-positive breast cancer is surgery following neoadjuvant chemotherapy (NAC). Using NAC in advanced-stage tumors and biologically aggressive subtypes can lead to de-escalation in surgical treatment for the breast and axilla.
Previously, NAC was believed to alter lymphatic drainage due to fibrosis and tumor emboli in lymphatic channels. However, the theAmerican College of Surgeons Oncology Group (ACOSOG) Z1071 and Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA) trials investigated the performance of sentinel lymph node biopsy (SLNB) after NAC in patients with proven axillary lymph node involvement at the initial biopsy.
In contemporary breast cancer management, particularly in the axillary approach, less invasive techniques are becoming increasingly common. This raises the question of whether there might be a patient group where SLNB could be avoided.
In this study, the investigators sought a new method to evaluate the axilla after NAC in patients with known axillary involvement previously. For this purpose, the investigators performed an ultrasound-guided needle biopsy on the clipped axillary lymph node with known metastasis before the planned surgery, aiming to assess the axilla without performing SLNB after treatment. Additionally, the investigators investigated which patient group might benefit more from this predictability based on molecular subtypes and clinical-pathological features.
Detailed description
The current study was designed as a prospective randomized clinical trial conducted at two participating centers to evaluate the predictability of sentinel lymph node biopsy (SLNB) using axillary ultrasound-guided fine-needle aspiration biopsy (FNAB) and core needle biopsy (CNB) in patients with histologically proven axillary lymph node metastasis after neoadjuvant chemotherapy (NAC). The study was initiated after obtaining approval from the local ethics committee (Dated:06.03.3023/decision no:E-10840098-772.02-1685).
Patients:
Female patients aged 18 years and above with clinical stage T1-3 and biopsy-proven N1 breast cancer who received NAC were included in the study. Exclusion criteria were a history of axillary surgery or SLNB, prior axillary excisional lymph node surgery, N2-3 disease with a decision for initial axillary lymph node dissection (ALND), diagnosis of inflammatory breast cancer, presence of distant metastasis, incomplete chemotherapy, pregnancy, and lactation.
All participants underwent breast ultrasonography, mammography, and magnetic resonance imaging for imaging before NAC. Clipped lymph nodes that were histopathologically proven to be metastatic at the time of diagnosis underwent ultrasonography-guided CNB or FNAB seven days before surgery. Histopathological results after biopsy were grouped as negative, positive, and non-diagnostic for metastasis.
Patients were randomized into two groups based on the initial biopsy method. In Group A, patients with axillary metastasis identified by FNAB were subjected to repeat ultrasound-guided FNAB after completion of neoadjuvant treatment, while in Group B, patients with axillary metastasis identified by CNB underwent repeat biopsy using the same method after completing neoadjuvant treatment.
Surgical Technique and Nodal Evaluation:
SLNB technique using isosulfan blue dye was performed for axillary evaluation, and all patients had the clipped lymph node excised under ultrasound guidance with a guide wire placed preoperatively.
Inter-group Comparison:
Sensitivity, specificity, false-negative rate (FNR), false-positive rate (FPR), and accuracy values were compared between the two groups based on the needle biopsy and SLNB performed after NAC. In patients re-evaluated with FNAB and CNB after NAC, the effects of patient age, tumor size, radiological features of breast cancer and axillary lymph node, tumor and lymph node size, histopathological type and grade of tumor, receptor characteristics, maximum standardized uptake value (SUV) of the breast and axillary lymph node on Positron Emission Tomography and Computed Tomography (PET-CT), and differences in ER, PR, Her-2, and Ki 67 receptors in the final pathology were investigated on sensitivity, specificity, FNR, FPR, and accuracy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were randomized into two groups based on the initial biopsy method. In Group A, patients with axillary metastasis identified by FNAB were subjected to repeat ultrasound-guided FNAB after completion of neoadjuvant treatment, while in Group B, patients with axillary metastasis identified by CNB underwent repeat biopsy using the same method after completing neoadjuvant treatment. The obtained biopsies were sent for histopathological evaluation without revealing patient names to avoid influencing the research results, and the surgical team was not informed of the biopsy results. During surgery, both dyed lymph nodes and clipped lymph nodes were excised for SLNB and assessed by frozen section evaluation. Thus, the predictability of axillary metastasis by preoperative FNAB/CNB was tested.
| Arm | Type | Receives |
|---|---|---|
| Group 1 = Fine needle aspiration biopsy | Active comparator | Procedure: Axillary sentinal lymph node biopsyIn Group A, patients with axillary metastasis identified by FNAB were subjected to repeat ultrasound-guided FNAB after completion of neoadjuvant treatment, The obtained biopsies were sent for histopathological evaluation without revealing patient names to avoid influencing the research results, and the surgical team was not informed of the biopsy results. During surgery, both dyed lymph nodes and clipped lymph nodes were excised for SLNB and assessed by frozen section evaluation. |
| Group 2 = Core biopsy | Active comparator | Procedure: Axillary sentinal lymph node biopsyin Group B, patients with axillary metastasis identified by CNB underwent repeat biopsy using the same method after completing neoadjuvant treatment.The obtained biopsies were sent for histopathological evaluation without revealing patient names to avoid influencing the research results, and the surgical team was not informed of the biopsy results. During surgery, both dyed lymph nodes and clipped lymph nodes were excised for SLNB and assessed by frozen section evaluation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years-old female patients
- Clinical stage T1-3 and biopsy-proven N1 breast cancer
- Axillary nodal involvement
- Volunteer to participate in to study
Key exclusion criteria (7 listed)
- A history of axillary surgery or SLNB, prior axillary excisional lymph node surgery,
- N2-3 disease with a decision for initial axillary lymph node dissection (ALND),
- Diagnosis of inflammatory breast cancer,
- Presence of distant metastasis
- Incomplete chemotherapy, pregnancy, and lactation
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 |
|---|---|---|
| Axillary sentinal lymph node biopsyAlso: Axillary dissectionFor SLNB evaluation, multiple sections of the excised lymph node were stained with hematoxylin and eosin (H\&E) at a thickness greater than 2 mm. Lymph nodes with metastasis greater than 2 mm were defined as positive SLNB. Macroscopic metastasis was considered positive in the evaluation for the axilla, while benign histological characteristics were considered negative. The presence of micrometastasis and isolated tumor cells was also noted. The size and diameter of the metastatic lymph node were considered in the evaluation. SLNB technique using isosulfan blue dye was performed for axillary evaluation, and all patients had the clipped lymph node excised under ultrasound guidance with a guide wire placed preoperatively. | Procedure or surgery | Group 1 = Fine needle aspiration biopsy, Group 2 = Core biopsy |
Primary outcome
Prediction of axillary status after neoadjuvant chemotherapy without SLNB
Time frame: through study completion, an average of 6 month
In this study, the investigators sought a new method to evaluate the axilla after NAC in patients with known axillary involvement previously. For this purpose, the investigators performed an ultrasound-guided needle biopsy on the clipped axillary lymph node with known metastasis before the planned surgery, aiming to assess the axilla without performing SLNB after treatment.
1 secondary outcome
The investigators investigated which patient group might benefit more from this prediction based on molecular subtypes and the clinical-pathological features
Time frame: through study completion, an average of 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Background: PubMed 26110204You S, Kang DK, Jung YS, An YS, Jeon GS, Kim TH. Evaluation of lymph node status after neoadjuvant chemotherapy in breast cancer patients: comparison of diagnostic performance of ultrasound, MRI and (1)(8)F-FDG PET/CT. Br J Radiol. 2015 Aug;88(1052):20150143. doi: 10.1259/bjr.20150143.
- Background: PubMed 28350255Ha SM, Cha JH, Kim HH, Shin HJ, Chae EY, Choi WJ. Diagnostic performance of breast ultrasonography and MRI in the prediction of lymph node status after neoadjuvant chemotherapy for breast cancer. Acta Radiol. 2017 Oct;58(10):1198-1205. doi: 10.1177/0284185117690421. Epub 2017 Mar 28.
- Individual participant dataSharing planned: No. We will not share individual participant data
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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.
Pelin Basim, As. prof, MD principal investigator
Medipol University / General Surgery Department
Emine YILDIRIM, As. prof, MD principal investigator
Gaziosmanpasa Training and Research Hospital / General Surgery Department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axillary sentinal lymph node biopsy in people with Breast Cancer and Breast Neoplasms, run by Medipol University at 2 sites in Turkey (Türkiye).
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pelin Basim, As. prof, MD (+905337186679, pelinakbaba@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of axillary status after neoadjuvant chemotherapy without SLNB (time frame: through study completion, an average of 6 month). 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 NCT06096545, which also lists 2 linked publications.
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 Mar 2024.