Early Breast CancerLumiNOdeNCT07579286
Refusal of Sentinel Lymph Node Biopsy in Patients With Luminal A Subtype Early Breast Cancer
A study testing breast resection and Breast resection with sentinel lymph node biopsy in people with Early Breast Cancer, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
Trial summary
Sentinel lymph node biopsy (SLNB) is the standard of axillary lymph node surgical staging in patients with early breast cancer. The main goal of the study is to abandon axillary surgery in patients over 59 years old with early, luminal A, clinical lymph node negative breast cancer. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Early Breast Cancer
- What is being tested?
- breast resection and Breast resection with sentinel lymph node biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 27 Jul 2023to 25 May 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HER2-negative breast cancer (ER +/ PR +), Ki67 <= 30%, G1-2
- age> 59 years.
- morphologically confirmed diagnosis of breast cancer, IA-IIA stage
- ECOG score 0-2.
- the absence of contraindications to surgical intervention (including anesthetic risk is taken into account).
- patient is able to provide informed consent and sign approved consent forms to participate in the study.
- patients after surgical treatment in the scope of breast resection with sentinel lymph node biopsy (SLNB, group 1) or without axillary surgery (without SLNB, group 2).
- N0 status of axillary lymph nodes according to ultrasound and SPECT-CT of the breast with 99mTc-Technetril.
Who cannot join
- Inconsistency with inclusion criteria.
- stage T2-4, N1 or M1 cancer
- severe uncontrolled concomitant chronic diseases or acute diseases
- previous/concurrent malignancy or history of radiation therapy to the chest wall region
- any condition that is a contraindication to radiation therapy
- 5. pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, Russian Federation, 197758
About this study
Sentinel lymph node biopsy (SLNB) is the standard of axillary lymph node surgical staging in patients with early breast cancer.
The main goal of the study is to abandon axillary surgery in patients over 59 years old with early, luminal A, clinical lymph node negative breast cancer.
Read the detailed description
Sentinel lymph node biopsy (SLNB) has replaced axillary lymph node dissection (ALND) in early breast cancer and has been widely implemented in clinical practice worldwide. The primary goal of SLNB is to reduce the complications associated with ALND while maintaining high anti-tumor efficacy.
However, many studies have shown that although SLNB reduces the complications typical of ALND, the incidence of these complications remains high: the risk of developing lymphedema is 7.5%, sensory disturbances and restrictions in arm movement occur in 5-8% of cases. It is well known that these complications negatively affect the physical, psychological, and emotional well-being of women, thereby reducing their quality of life.
It is also noteworthy that there is a relatively high rate of false-negative results in SLNB (ranging from 4.6% to 16.7%).
Due to advances in imaging diagnostic methods, the accuracy of preoperative assessment of lymph node status has significantly improved. According to studies, the sensitivity and specificity of ultrasound examination of the axillary lymph nodes in diagnosing lymph node involvement are 85% and 78%, respectively. Other sources, however, report a 15.5% of false-negative rate in preoperative ultrasound examinations. Consequently, the diagnostic field of standard radiological methods (ultrasound, CT, MRI) in assessing axillary lymph node status is deemed 'insufficient'. Mammolymphoscintigraphy is an additional diagnostic method based on the detection of pathophysiological alterations in the energy metabolism of tumor cells at the subcellular and molecular levels. Moreover, since metabolic changes usually precede anatomical reorganization, functional imaging methods are regarded as having greater sensitivity in identifying neoplastic changes. Our own experience with radiolabeled 99mTc lipophilic cations in diagnosing axillary lymph node metastasis breast cancer demonstrated that the sensitivity, specificity, and overall accuracy of the method were 80%, 84%, and 76%, respectively. Therefore, in this study, we are incorporating mammolymphoscintigraphy as an essential method for determining lymph node status.
In recent years, the status of axillary lymph nodes has played a diminishing role for adjuvant therapy in early breast cancer patients. Furthermore, in the luminal A subtype of early breast cancer, hormone therapy will be prescribed in the adjuvant setting regardless of axillary lymph node status.
Thus, the existing clinical data do not allow for a definitive conclusion regarding the role of SLNB in early breast cancer patients with the luminal A subtype. To address this and other questions, the present study was initiated
- Conditions
- Early Breast Cancer
- Being tested
- breast resection, Breast resection with sentinel lymph node biopsy
- Keywords
- early breast cancer, radiotherapy, refusal of Sentinel Lymph Node Biopsy, SLNB, breast surgery, Mammolymphoscintigraphy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast resectionProcedure or surgery
breast resection without sentinel lymph node biopsy, radiotherapy to the breast area and sentinel lymph nodes
Breast resection with sentinel lymph node biopsyProcedure or surgery
Breast resection with sentinel lymph node biopsy, radiotherapy to the breast and axilla according to current treatment standards
| Study group | Role | What they receive |
|---|---|---|
| Group 2:breast resection without sentinel lymph node biopsy, radiotherapy to the breast area and SLN | Experimental | 1. Prior to the surgical phase of treatment, all patients undergo SPECT-CT of the breasts with 99mTc-Technetril and SPECT-CT of the sentinel lymph nodes with Tc99m-colloid. A sectoral resection of the breast is performed according to the standard technique, with subsequent histological examination of the excised tissue. Surgical staging using sentinel lymph node biopsy is not performed.
2. In the next phase, 4-12 weeks after surgery, 3D conformal radiotherapy is administered to the remaining breast tissue, including the region of the sentinel lymph nodes as identified by the preoperative SPECT-CT of the sentinel lymph nodes with Tc99m-colloid. Radiation planning is carried out according to ESTRO protocols, modified in accordance with the atlas of the sentinel lymph nodes.
3. Based on the postoperative histological findings, adjuvant systemic therapy is prescribed to the patient in accordance with current clinical guidelines. Receives: Procedure: breast resection |
| Group 1: Breast resection with biopsy of the sentinel lymph node, radiotherapy | Active comparator | 1. Prior to surgical treatment all patients undergo breast SPECT-CT using 99mTc-Technetril and SPECT-CT of the SLN using Tc99m-colloid. The patient then undergoes a sectoral resection of the breast with a sentinel lymph node biopsy, followed by histological analysis of the excised tissue.
2. In the next stage, 3D conformal RT is administered to the remaining breast tissue 4 to 12 weeks after the surgical treatment. In patients who have undergone SLNB, only the remaining breast tissue is irradiated, without irradiation of the axillary region, provided that the postoperative histological examination shows no evidence of sentinel lymph node involvement. If metastatic involvement of the SLN is detected, additional RT of the axillary region is performed. Radiation planning is carried out in accordance with ESTRO protocols.
3. Based on the postoperative histological findings, the patient is prescribed adjuvant systemic therapy in accordance with current clinical guidelines. Receives: Procedure: Breast resection with sentinel lymph node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axillary recurrence rate.
Compare the rate of axillary recurrences in patients with early breast cancer who did not undergo sentinel lymph node biopsy (SLNB) versus those who received standard treatment with SLNB.
Measured: 2, 3, 5 years
Secondary outcomes (3)
locoregional recurrence-free survival
Compare locoregional recurrence-free survival in the study groups of patients with early breast cancer
Measured: 5 and 10 years
overall survival and recurrence-free survival
Compare overall survival and recurrence-free survival in the study groups of patients with early breast cancer
Measured: 5 and 10 years
frequency and severity of adverse events
Compare the frequency and severity of adverse events, using the current version 5.0 of the CTCAE
Measured: 3, 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start27 Jul 2023
- Primary completion25 May 2027 (estimated)
- Study completion25 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomized using the envelope method in a 1:4 ratio. Thus, for every patient undergoing SLNB as a surgical treatment stage, there are four female patients undergoing only sectoral breast resection without SLNB. Baseline patient information is collected (including medical history with details on concomitant therapy and findings from the initial physical examination), along with laboratory tests. The instrumental diagnostic methods used prior to treatment and during subsequent patient follow-up include: ultrasound, SPECT/CT of the breasts with 99mTc-Technetium, and SPECT/CT visualization of the sentinel lymph nodes using radiocolloids performed before the start of treatment.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N.N. Petrov National Medical Research Center of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579286
- Sponsor's protocol ID
- 2417313
- Other IDs
- 24/173
- Acronym
- LumiNOde
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refusal of Sentinel Lymph Node Biopsy in Patients With Luminal A Subtype Early Breast Cancer
- ClinicalTrials.gov ID
- NCT07579286
- Acronym / sponsor ID
- LumiNOde / 2417313
- Conditions
- Early Breast Cancer
- Keywords
- early breast cancer, radiotherapy, refusal of Sentinel Lymph Node Biopsy, SLNB, breast surgery, Mammolymphoscintigraphy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- N.N. Petrov National Medical Research Center of OncologyUniversity, hospital or other
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 25 May 2027 (estimated)
- Study completion
- 25 May 2027 (estimated)
- First posted
- 12 May 2026 (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.
Sentinel lymph node biopsy (SLNB) is the standard of axillary lymph node surgical staging in patients with early breast cancer.
The main goal of the study is to abandon axillary surgery in patients over 59 years old with early, luminal A, clinical lymph node negative breast cancer.
Detailed description
Sentinel lymph node biopsy (SLNB) has replaced axillary lymph node dissection (ALND) in early breast cancer and has been widely implemented in clinical practice worldwide. The primary goal of SLNB is to reduce the complications associated with ALND while maintaining high anti-tumor efficacy.
However, many studies have shown that although SLNB reduces the complications typical of ALND, the incidence of these complications remains high: the risk of developing lymphedema is 7.5%, sensory disturbances and restrictions in arm movement occur in 5-8% of cases. It is well known that these complications negatively affect the physical, psychological, and emotional well-being of women, thereby reducing their quality of life.
It is also noteworthy that there is a relatively high rate of false-negative results in SLNB (ranging from 4.6% to 16.7%).
Due to advances in imaging diagnostic methods, the accuracy of preoperative assessment of lymph node status has significantly improved. According to studies, the sensitivity and specificity of ultrasound examination of the axillary lymph nodes in diagnosing lymph node involvement are 85% and 78%, respectively. Other sources, however, report a 15.5% of false-negative rate in preoperative ultrasound examinations. Consequently, the diagnostic field of standard radiological methods (ultrasound, CT, MRI) in assessing axillary lymph node status is deemed 'insufficient'. Mammolymphoscintigraphy is an additional diagnostic method based on the detection of pathophysiological alterations in the energy metabolism of tumor cells at the subcellular and molecular levels. Moreover, since metabolic changes usually precede anatomical reorganization, functional imaging methods are regarded as having greater sensitivity in identifying neoplastic changes. Our own experience with radiolabeled 99mTc lipophilic cations in diagnosing axillary lymph node metastasis breast cancer demonstrated that the sensitivity, specificity, and overall accuracy of the method were 80%, 84%, and 76%, respectively. Therefore, in this study, we are incorporating mammolymphoscintigraphy as an essential method for determining lymph node status.
In recent years, the status of axillary lymph nodes has played a diminishing role for adjuvant therapy in early breast cancer patients. Furthermore, in the luminal A subtype of early breast cancer, hormone therapy will be prescribed in the adjuvant setting regardless of axillary lymph node status.
Thus, the existing clinical data do not allow for a definitive conclusion regarding the role of SLNB in early breast cancer patients with the luminal A subtype. To address this and other questions, the present study was initiated
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are randomized using the envelope method in a 1:4 ratio. Thus, for every patient undergoing SLNB as a surgical treatment stage, there are four female patients undergoing only sectoral breast resection without SLNB. Baseline patient information is collected (including medical history with details on concomitant therapy and findings from the initial physical examination), along with laboratory tests. The instrumental diagnostic methods used prior to treatment and during subsequent patient follow-up include: ultrasound, SPECT/CT of the breasts with 99mTc-Technetium, and SPECT/CT visualization of the sentinel lymph nodes using radiocolloids performed before the start of treatment.
| Arm | Type | Receives |
|---|---|---|
| Group 2:breast resection without sentinel lymph node biopsy, radiotherapy to the breast area and SLN | Experimental | Procedure: breast resection1. Prior to the surgical phase of treatment, all patients undergo SPECT-CT of the breasts with 99mTc-Technetril and SPECT-CT of the sentinel lymph nodes with Tc99m-colloid. A sectoral resection of the breast is performed according to the standard technique, with subsequent histological examination of the excised tissue. Surgical staging using sentinel lymph node biopsy is not performed. 2. In the next phase, 4-12 weeks after surgery, 3D conformal radiotherapy is administered to the remaining breast tissue, including the region of the sentinel lymph nodes as identified by the preoperative SPECT-CT of the sentinel lymph nodes with Tc99m-colloid. Radiation planning is carried out according to ESTRO protocols, modified in accordance with the atlas of the sentinel lymph nodes. 3. Based on the postoperative histological findings, adjuvant systemic therapy is prescribed to the patient in accordance with current clinical guidelines. |
| Group 1: Breast resection with biopsy of the sentinel lymph node, radiotherapy | Active comparator | Procedure: Breast resection with sentinel lymph node biopsy1. Prior to surgical treatment all patients undergo breast SPECT-CT using 99mTc-Technetril and SPECT-CT of the SLN using Tc99m-colloid. The patient then undergoes a sectoral resection of the breast with a sentinel lymph node biopsy, followed by histological analysis of the excised tissue. 2. In the next stage, 3D conformal RT is administered to the remaining breast tissue 4 to 12 weeks after the surgical treatment. In patients who have undergone SLNB, only the remaining breast tissue is irradiated, without irradiation of the axillary region, provided that the postoperative histological examination shows no evidence of sentinel lymph node involvement. If metastatic involvement of the SLN is detected, additional RT of the axillary region is performed. Radiation planning is carried out in accordance with ESTRO protocols. 3. Based on the postoperative histological findings, the patient is prescribed adjuvant systemic therapy in accordance with current clinical guidelines. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- HER2-negative breast cancer (ER +/ PR +), Ki67 <= 30%, G1-2
- age> 59 years.
- morphologically confirmed diagnosis of breast cancer, IA-IIA stage
- ECOG score 0-2.
- the absence of contraindications to surgical intervention (including anesthetic risk is taken into account).
Key exclusion criteria (6 listed)
- Inconsistency with inclusion criteria.
- stage T2-4, N1 or M1 cancer
- severe uncontrolled concomitant chronic diseases or acute diseases
- previous/concurrent malignancy or history of radiation therapy to the chest wall region
- any condition that is a contraindication to radiation therapy
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 |
|---|---|---|
| breast resectionbreast resection without sentinel lymph node biopsy, radiotherapy to the breast area and sentinel lymph nodes | Procedure or surgery | Group 2:breast resection without sentinel lymph node biopsy, radiotherapy to the breast area and SLN |
| Breast resection with sentinel lymph node biopsyBreast resection with sentinel lymph node biopsy, radiotherapy to the breast and axilla according to current treatment standards | Procedure or surgery | Group 1: Breast resection with biopsy of the sentinel lymph node, radiotherapy |
Primary outcome
Axillary recurrence rate.
Time frame: 2, 3, 5 years
Compare the rate of axillary recurrences in patients with early breast cancer who did not undergo sentinel lymph node biopsy (SLNB) versus those who received standard treatment with SLNB.
3 secondary outcomes
locoregional recurrence-free survival
Time frame: 5 and 10 years
overall survival and recurrence-free survival
Time frame: 5 and 10 years
frequency and severity of adverse events
Time frame: 3, 5 and 10 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 12 May 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breast resection and Breast resection with sentinel lymph node biopsy in people with Early Breast Cancer, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
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 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: looking for participants now, as of the sponsor's last update on 12 May 2026. 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 Russia. 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 Petr Krivorotko, Degree (+79219597722, dr.krivorotko@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axillary recurrence rate. (time frame: 2, 3, 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 12 May 2026.