Breast CancerNCT03556397
Sentinel Lymph Node Biopsy in Patients With Breast Cancer After Neoadjuvant Therapy
A study testing Sentinel lymph node biopsy (SLNB) and Axillary dissection in people with Breast Cancer, run by University Hospital Ostrava at 2 sites in Czechia.
Trial summary
The aim of this study is to create clear indications for Sentinel Lymph Node Biopsy (SLNB) or Axillary Dissection (AD) in women with breast carcinoma after neoadjuvant therapy by studying the false negative rate of SLNB. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Sentinel lymph node biopsy (SLNB) and Axillary dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 Jan 2018to 30 Nov 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of breast carcinoma confirmed by biopsy
- neoadjuvant therapy
- examination of axillary lymph nodes clinically and by ultrasound
- surgical therapy after neoadjuvant therapy
Who cannot join
- inflammatory breast carcinoma
- incomplete neoadjuvant therapy
- previous sentinel lymph node biopsy performed on the same side of the body
- disagreement with participation in the study
- other malignities influencing the treatment of breast carcinoma
- distant metastases
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Silesian Hospital in Opava
Opava, Moravian-Silesian Region, 746 01
University Hospital Ostrava
Ostrava-Poruba, Moravian-Silesian Region, 708 52
About this study
The aim of this study is to create clear indications for Sentinel Lymph Node Biopsy (SLNB) or Axillary Dissection (AD) in women with breast carcinoma after neoadjuvant therapy by studying the false negative rate of SLNB.
Read the detailed description
The main object of the study is to evaluate, whether sentinel lymph node biopsy (SLNB) at women with breast cancer after neoadjuvant therapy is a method with a high false-negative rate. Patients will be classified into groups according to histological findings during SLNB, clinical and ultrasonography (USG) findings in the axilla. The aim of this study is to create clear indications for SLNB or axillary dissection (AD). In case of extension of SLNB indications, there will be a decrease in morbidity after surgical therapy when compared to AD, which will mean a profit for the patients.
- Conditions
- Breast Cancer
- Being tested
- Sentinel lymph node biopsy (SLNB), Axillary dissection
- Keywords
- breast cancer, neoadjuvant therapy, sentinel lymph node biopsy, axillary dissection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel lymph node biopsy (SLNB)Procedure or surgery
Sentinel lymph node biopsy will be performed in the patients
Axillary dissectionProcedure or surgery
Axillary dissection procedure will be performed in the patients
| Study group | Role | What they receive |
|---|---|---|
| cN0 before and after neoadjuvant th., SLNB - negative, no AD | Experimental | Patients with cN0 before and after neoadjuvant therapy, SLNB - negative, without AD Receives: Procedure: Sentinel lymph node biopsy (SLNB) |
| cN0 before and after neoadjuvant th., SLNB - posit., AD | Experimental | Patients with cN0 before and after neoadjuvant therapy, SLNB - positive, AD (separated histological examination of lymph nodes in levels I and II) Receives: Procedure: Sentinel lymph node biopsy (SLNB); Procedure: Axillary dissection |
| cN1 before neoadj. th., cN0 after neoadj. th., SLNB, AD | Experimental | Patients with cN1 before neoadjuvant th., cN0 after neoadjuvant therapy, SLNB, AD (separated histological examination of lymph nodes in levels I and II) Receives: Procedure: Sentinel lymph node biopsy (SLNB); Procedure: Axillary dissection |
| cN1 after neoadjuvant therapy, SLNB, AD | Experimental | Patients with cN1 after neoadjuvant therapy, SLNB, AD. Receives: Procedure: Sentinel lymph node biopsy (SLNB); Procedure: Axillary dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clear indications for SLNB or axillary dissection
Clear indications for SLNB or axillary dissection (AD) in women with breast carcinoma after neoadjuvant therapy using false-negativity rate of SLNB. False-negativity rate of SLNB under 10% is acceptable for avoiding AD.
Measured: 24 months
Secondary outcomes (5)
Morbidity
Morbidity after SLNB and AD will be assessed by check-ups provided by clinicians. The result will be the percentage of patients which suffer from some complications after SLNB or AD. Common morbidity rate after AD is 20%, after SLNB 1-2%.
Measured: 24 months
Changes in the Quality of Life
Changes in the Quality of Life will be assessed using the standardised World Health Organisation Quality of Life (WHOQOL) questionnaire.
Measured: 24 months
Overall Survival
The overall survival (in months, years) of the patients will be assessed.
Measured: 24 months
Disease-free Survival
The disease-free survival (in months, years) of the patients will be assessed.
Measured: 24 months
Progression-free Survival
The progression-free survival (in months, years) of the patients will be assessed.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start1 Jan 2018
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
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
- The patients will be divided into four groups, according to the stage of the disease prior to neoadjuvant therapy.
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- Silesian Hospital in Opava
- Responsible party
- Sponsor
- Investigators
- Jan Žatecký, MD, Principal investigator, Silesian Hospital in Opava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556397
- Sponsor's protocol ID
- CHIR-01-sentinel
- Other IDs
- 11360/6199/1610/021554
- Status last verified
- Feb 2021
- First submitted
- 24 May 2018
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators have not decided to make individual participant data available to other researchers.
Publications
Kuehn T, Bauerfeind I, Fehm T, Fleige B, Hausschild M, Helms G, Lebeau A, Liedtke C, von Minckwitz G, Nekljudova V, Schmatloch S, Schrenk P, Staebler A, Untch M. Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study. Lancet Oncol. 2013 Jun;14(7):609-18. doi: 10.1016/S1470-2045(13)70166-9. Epub 2013 May 15.
PubMed 23683750Caudle AS, Hunt KK, Tucker SL, Hoffman K, Gainer SM, Lucci A, Kuerer HM, Meric-Bernstam F, Shah R, Babiera GV, Sahin AA, Mittendorf EA. American College of Surgeons Oncology Group (ACOSOG) Z0011: impact on surgeon practice patterns. Ann Surg Oncol. 2012 Oct;19(10):3144-51. doi: 10.1245/s10434-012-2531-z. Epub 2012 Jul 31.
PubMed 22847123
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Biopsy in Patients With Breast Cancer After Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT03556397
- Acronym / sponsor ID
- CHIR-01-sentinel
- Conditions
- Breast Cancer
- Keywords
- breast cancer, neoadjuvant therapy, sentinel lymph node biopsy, axillary dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Collaborators
- Silesian Hospital in Opava
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 14 Jun 2018 (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 aim of this study is to create clear indications for Sentinel Lymph Node Biopsy (SLNB) or Axillary Dissection (AD) in women with breast carcinoma after neoadjuvant therapy by studying the false negative rate of SLNB.
Detailed description
The main object of the study is to evaluate, whether sentinel lymph node biopsy (SLNB) at women with breast cancer after neoadjuvant therapy is a method with a high false-negative rate. Patients will be classified into groups according to histological findings during SLNB, clinical and ultrasonography (USG) findings in the axilla. The aim of this study is to create clear indications for SLNB or axillary dissection (AD). In case of extension of SLNB indications, there will be a decrease in morbidity after surgical therapy when compared to AD, which will mean a profit for the patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The patients will be divided into four groups, according to the stage of the disease prior to neoadjuvant therapy.
| Arm | Type | Receives |
|---|---|---|
| cN0 before and after neoadjuvant th., SLNB - negative, no AD | Experimental | Procedure: Sentinel lymph node biopsy (SLNB)Patients with cN0 before and after neoadjuvant therapy, SLNB - negative, without AD |
| cN0 before and after neoadjuvant th., SLNB - posit., AD | Experimental | Procedure: Sentinel lymph node biopsy (SLNB), Procedure: Axillary dissectionPatients with cN0 before and after neoadjuvant therapy, SLNB - positive, AD (separated histological examination of lymph nodes in levels I and II) |
| cN1 before neoadj. th., cN0 after neoadj. th., SLNB, AD | Experimental | Procedure: Sentinel lymph node biopsy (SLNB), Procedure: Axillary dissectionPatients with cN1 before neoadjuvant th., cN0 after neoadjuvant therapy, SLNB, AD (separated histological examination of lymph nodes in levels I and II) |
| cN1 after neoadjuvant therapy, SLNB, AD | Experimental | Procedure: Sentinel lymph node biopsy (SLNB), Procedure: Axillary dissectionPatients with cN1 after neoadjuvant therapy, SLNB, AD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of breast carcinoma confirmed by biopsy
- neoadjuvant therapy
- examination of axillary lymph nodes clinically and by ultrasound
- surgical therapy after neoadjuvant therapy
Key exclusion criteria (6 listed)
- inflammatory breast carcinoma
- incomplete neoadjuvant therapy
- previous sentinel lymph node biopsy performed on the same side of the body
- disagreement with participation in the study
- other malignities influencing the treatment of breast carcinoma
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 |
|---|---|---|
| Sentinel lymph node biopsy (SLNB)Sentinel lymph node biopsy will be performed in the patients | Procedure or surgery | cN0 before and after neoadjuvant th., SLNB - negative, no AD, cN0 before and after neoadjuvant th., SLNB - posit., AD, cN1 after neoadjuvant therapy, SLNB, AD, cN1 before neoadj. th., cN0 after neoadj. th., SLNB, AD |
| Axillary dissectionAxillary dissection procedure will be performed in the patients | Procedure or surgery | cN0 before and after neoadjuvant th., SLNB - posit., AD, cN1 after neoadjuvant therapy, SLNB, AD, cN1 before neoadj. th., cN0 after neoadj. th., SLNB, AD |
Primary outcome
Clear indications for SLNB or axillary dissection
Time frame: 24 months
Clear indications for SLNB or axillary dissection (AD) in women with breast carcinoma after neoadjuvant therapy using false-negativity rate of SLNB. False-negativity rate of SLNB under 10% is acceptable for avoiding AD.
5 secondary outcomes
Morbidity
Time frame: 24 months
Changes in the Quality of Life
Time frame: 24 months
Overall Survival
Time frame: 24 months
Disease-free Survival
Time frame: 24 months
Progression-free Survival
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Background: PubMed 23683750Kuehn T, Bauerfeind I, Fehm T, Fleige B, Hausschild M, Helms G, Lebeau A, Liedtke C, von Minckwitz G, Nekljudova V, Schmatloch S, Schrenk P, Staebler A, Untch M. Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study. Lancet Oncol. 2013 Jun;14(7):609-18. doi: 10.1016/S1470-2045(13)70166-9. Epub 2013 May 15.
- Background: PubMed 22847123Caudle AS, Hunt KK, Tucker SL, Hoffman K, Gainer SM, Lucci A, Kuerer HM, Meric-Bernstam F, Shah R, Babiera GV, Sahin AA, Mittendorf EA. American College of Surgeons Oncology Group (ACOSOG) Z0011: impact on surgeon practice patterns. Ann Surg Oncol. 2012 Oct;19(10):3144-51. doi: 10.1245/s10434-012-2531-z. Epub 2012 Jul 31.
- Individual participant dataSharing planned: Undecided. The investigators have not decided to make individual participant data available to other researchers.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Jan Žatecký, MD principal investigator
Silesian Hospital in Opava
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel lymph node biopsy (SLNB) and Axillary dissection in people with Breast Cancer, run by University Hospital Ostrava at 2 sites in Czechia.
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 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: finished, as of the sponsor's last update on 18 Feb 2021. 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 Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clear indications for SLNB or axillary dissection (time frame: 24 months). 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 NCT03556397, 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 18 Feb 2021.