Breast CancerNCT05935150
Omission of SLNB in CN0 Early Breast Cancer
A study testing Omit SLNB in people with Breast Cancer and Clinically Assessed Negative Axillary Lymph Nodes, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The OMSLNB trial adopts a prospective, single-arm, non-inferiority, phase-II, open-label study design. Patients with unilateral invasive breast cancer （tumor ≤3cm） and assessed as cN0 will be eligible for inclusion, enrolled patients are required to complete 2 or more imaging tests including axillary ultrasound… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Clinically Assessed Negative Axillary Lymph Nodes, Sentinel Lymph Node
- What is being tested?
- Omit SLNB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2023to 1 Oct 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18-70 years;
- Pathologically confirmed invasive breast cancer (regardless of pathological type) with a tumor diameter ≤ 3 cm, and planning to undergo breast surgery;
- Negative axillary lymph nodes assessed by physical examination and imaging (2 or more of the following tests including ultrasound, breast MRI, breast PET-CT, breast PET-MRI, breast PET);
- All patients are required to undergo immunohistochemical staining for Estrogen Receptor (ER), Progesterone Receptor (PR), human epidermal growth factor receptor 2 (HER2), Ki-67 proliferation index, and further fluorescence in situ hybridization (FISH) should be performed in HER2 2+ cases;
- Good compliance, normal comprehension and ability to receive treatment and follow-up as required;
- ECOG score 0-1;
- Patients volunteered for this study and signed the informed consent form.
Who cannot join
- Bilateral/lactating/pregnant breast cancer;
- Previous history of malignant tumor or neoplasm;
- Clinical or imaging confirmation of distant metastasis;
- History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity;
- Prior history of radiotherapy to the breast or chest;
- Positive pathological margins after breast-conserving surgery or mastectomy;
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- Severe coagulation disorder, or a serious systemic disease, or an uncontrollable infection;
- Aspartate aminortransferse (AST) and Alanine aminotransferase (ALT) ≥ 1.5 times the upper limit of normal, alkaline phosphatase ≥ 2.5 times the upper limit of normal, total bilirubin ≥ 1.5 times the upper limit of normal, serum creatinine ≥ 1.5 times the upper limit of normal; left ventricular injection fraction (LVEF) < 50% on cardiac ultrasound;
- Inability to complete the full course of follow-up adjuvant therapy as prescribed by the doctor for various reasons;
- No personal freedom and independent civil capacity;
- Presence of mental disorders, addictions, etc;
- Not eligible for enrollmentas as judged by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Jue Wang, MD, 025-68306360, wangjue200011@njmu.edu.cn
About this study
Official title: Omission of Sentinel Lymph Node Biopsy (SLNB ) in Early Breast Cancer Patients with Clinically Assessed Negative Axillary Lymph Nodes (cN0): a Phase II, Prospective Clinical Trial
The OMSLNB trial adopts a prospective, single-arm, non-inferiority, phase-II, open-label study design. Patients with unilateral invasive breast cancer （tumor ≤3cm） and assessed as cN0 will be eligible for inclusion, enrolled patients are required to complete 2 or more imaging tests including axillary ultrasound assessed as axillary lymph node negative, and other tests including MRI, PET-CT, [18F]-FDG PET-MRI, eligible patients will avoid axillary surgery but will undergo breast surgery, which is not limited to breast-conserving surgery (BCS). So as to decrease the edema of upper arm, and finally improve the quality of life of the patients.
- Being tested
- Omit SLNB
- Keywords
- breast cancer, clinically assessed negative axillary lymph nodes, sentinel lymph node 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.
Omit SLNBProcedure or surgery
All patients enrolled have to receive two or more imaging tests including axillary ultrasound assessed as axillary lymph node negative, and other tests including MRI, PET-CT, [18F]-FDG PET-MRI, axillary surgery will be omitted for eligible patients, and BCS or mastectomy (allowing breast reconstruction) will be chosen voluntarily by the patient under the premise of ensuring therapeutic efficacy, patients receiving BCS must undergo whole breast irradiation (WBI) after surgery, and the radiotherapy target area does not include the axillary region.
| Study group | Role | What they receive |
|---|---|---|
| OMSLNB | Experimental | Not described Receives: Procedure: Omit SLNB |
What is being measured
The primary outcome is the main question the study is designed to answer.
invasive Disease-Free Survival (iDFS)
Time interval from the surgery to invasive local-regional recurrence, distant metastasis, contralateral invasive breast cancer, or death from any cause.
Measured: 3 years
Secondary outcomes (5)
Breast cancer-related lymphoedema (BCRL)
Objective evaluation of breast cancer-related lymphoedema (BCRL) by arm circumference measurements and bioelectrical impedance technology. In our study, BCRL is diagnosed in two ways：① Relative Volume Change (RVC ) >10% in the affected upper extremity. ②Bioelectrical impedance technology: the impedance ratio is defined as the ratio of the impedance of the healthy upper limb to the impedance of the affected upper limb, and BCRL is diagnosed when the patient's impedance ratio is higher than the mean + 2 standard deviations (SD) of healthy controls, and BCRL will be diagnosed by meeting one of them.
Measured: 3 years
Patient-reported outcomes (PROs)
Patients will be followed up with questionnaires using the FACT-B (Version 4.0) and Quick DASH at baseline, 1 week, 1, 3, 6, 12, 18, 24, and 36 months postoperatively, and the FACT-B scale will be used to assess changes in QoL from baseline to 3 years after surgery, and the Quick DASH scale will be used to assess changes in arm morbidity from baseline to 3 years after surgery.
Measured: 3 years
Locoregional Recurrence (LRR)
This includes both local and regional recurrences. Local recurrence is defined as recurrence in the ipsilateral breast, chest wall, skin or surgical scar. Regional recurrence is defined as recurrence in the affected lymphatic drainage area, including the axilla, supraclavicular region, subclavicular region, and internal mammary node area.
Measured: 3 years
Local Recurrence (LR)
Local recurrence is defined as recurrence in the ipsilateral breast, chest wall, skin or surgical scar.
Measured: 3 years
Regional Recurrence (RR)
Regional recurrence is defined as recurrence in the affected lymphatic drainage area, including the axilla, supraclavicular region, subclavicular region, and internal mammary node area.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start21 Jun 2023
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Oct 2027 (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.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- 311 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jue Wang, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Xiaoming Zha, MD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935150
- Sponsor's protocol ID
- OMSLNB
- Status last verified
- Oct 2024
- First submitted
- 2 Jun 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li X, Wang L, Wang Y, Ma L, Zheng R, Ding J, Gong Y, Yao H, Wang J, Zha X. Omission of sentinel lymph node biopsy in patients with clinically axillary lymph node-negative early breast cancer (OMSLNB): protocol for a prospective, non-inferiority, single-arm, phase II clinical trial in China. BMJ Open. 2024 Sep 10;14(9):e087700. doi: 10.1136/bmjopen-2024-087700.
PubMed 39260835
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omission of Sentinel Lymph Node Biopsy (SLNB ) in Early Breast Cancer Patients with Clinically Assessed Negative Axillary Lymph Nodes (cN0): a Phase II, Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT05935150
- Acronym / sponsor ID
- OMSLNB
- Keywords
- breast cancer, clinically assessed negative axillary lymph nodes, sentinel lymph node biopsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 311 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 7 Jul 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 OMSLNB trial adopts a prospective, single-arm, non-inferiority, phase-II, open-label study design. Patients with unilateral invasive breast cancer （tumor ≤3cm） and assessed as cN0 will be eligible for inclusion, enrolled patients are required to complete 2 or more imaging tests including axillary ultrasound assessed as axillary lymph node negative, and other tests including MRI, PET-CT, [18F]-FDG PET-MRI, eligible patients will avoid axillary surgery but will undergo breast surgery, which is not limited to breast-conserving surgery (BCS). So as to decrease the edema of upper arm, and finally improve the quality of life of the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OMSLNB | Experimental | Procedure: Omit SLNB |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients aged 18-70 years;
- Pathologically confirmed invasive breast cancer (regardless of pathological type) with a tumor diameter ≤ 3 cm, and planning to undergo breast surgery;
- Negative axillary lymph nodes assessed by physical examination and imaging (2 or more of the following tests including ultrasound, breast MRI, breast PET-CT, breast PET-MRI, breast PET);
- All patients are required to undergo immunohistochemical staining for Estrogen Receptor (ER), Progesterone Receptor (PR), human epidermal growth factor receptor 2 (HER2), Ki-67 proliferation index, and further fluorescence in situ hybridization (FISH) should be performed in HER2 2+ cases;
- Good compliance, normal comprehension and ability to receive treatment and follow-up as required;
Key exclusion criteria (12 listed)
- Bilateral/lactating/pregnant breast cancer;
- Previous history of malignant tumor or neoplasm;
- Clinical or imaging confirmation of distant metastasis;
- History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity;
- Prior history of radiotherapy to the breast or chest;
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 |
|---|---|---|
| Omit SLNBAll patients enrolled have to receive two or more imaging tests including axillary ultrasound assessed as axillary lymph node negative, and other tests including MRI, PET-CT, [18F]-FDG PET-MRI, axillary surgery will be omitted for eligible patients, and BCS or mastectomy (allowing breast reconstruction) will be chosen voluntarily by the patient under the premise of ensuring therapeutic efficacy, patients receiving BCS must undergo whole breast irradiation (WBI) after surgery, and the radiotherapy target area does not include the axillary region. | Procedure or surgery | OMSLNB |
Primary outcome
invasive Disease-Free Survival (iDFS)
Time frame: 3 years
Time interval from the surgery to invasive local-regional recurrence, distant metastasis, contralateral invasive breast cancer, or death from any cause.
5 secondary outcomes
Breast cancer-related lymphoedema (BCRL)
Time frame: 3 years
Patient-reported outcomes (PROs)
Time frame: 3 years
Locoregional Recurrence (LRR)
Time frame: 3 years
Local Recurrence (LR)
Time frame: 3 years
Regional Recurrence (RR)
Time frame: 3 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 15 Oct 2024.
- Derived from this study: PubMed 39260835Li X, Wang L, Wang Y, Ma L, Zheng R, Ding J, Gong Y, Yao H, Wang J, Zha X. Omission of sentinel lymph node biopsy in patients with clinically axillary lymph node-negative early breast cancer (OMSLNB): protocol for a prospective, non-inferiority, single-arm, phase II clinical trial in China. BMJ Open. 2024 Sep 10;14(9):e087700. doi: 10.1136/bmjopen-2024-087700.
- 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.
Xiaoming Zha, MD principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omit SLNB in people with Breast Cancer and Clinically Assessed Negative Axillary Lymph Nodes, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 15 Oct 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 China. 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?
Contact Jue Wang, MD (025-68306360, wangjue200011@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
invasive Disease-Free Survival (iDFS) (time frame: 3 years). 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 NCT05935150, 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 15 Oct 2024.