Refusal of Sentinel Lymph Node Biopsy in Patients With Luminal A Subtype Early Breast Cancer (LumiNOde)

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.

Study Overview

• Status: Recruiting
• Conditions: Early Breast Cancer
• Intervention / Treatment: Procedure: breast resection; Procedure: Breast resection with sentinel lymph node biopsy

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Petr Krivorotko, Degree; Phone Number: +79219597722; Email: dr.krivorotko@mail.ru
• Study Contact Backup: Name: Arina Gorina; Phone Number: +79185374992; Email: dr.arina_olegovna@mail.ru

Study Locations

• Russia
  • Russian Federation
    • Saint Petersburg, Russian Federation, Russia, 197758
      • Recruiting
      • N.N. Petrov National Medical Research Center of Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. HER2-negative breast cancer (ER +/ PR +), Ki67 <= 30%, G1-2
2. age> 59 years.
3. morphologically confirmed diagnosis of breast cancer, IA-IIA stage
4. ECOG score 0-2.
5. the absence of contraindications to surgical intervention (including anesthetic risk is taken into account).
6. patient is able to provide informed consent and sign approved consent forms to participate in the study.
7. 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).
8. N0 status of axillary lymph nodes according to ultrasound and SPECT-CT of the breast with 99mTc-Technetril.

Exclusion Criteria:

1. Inconsistency with inclusion criteria.
2. stage T2-4, N1 or M1 cancer
3. severe uncontrolled concomitant chronic diseases or acute diseases
4. previous/concurrent malignancy or history of radiation therapy to the chest wall region
5. any condition that is a contraindication to radiation therapy

5. pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 2:breast resection without sentinel lymph node biopsy, radiotherapy to the breast area and SLN; 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.; 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.; Based on the postoperative histological findings, adjuvant systemic therapy is prescribed to the patient in accordance with current clinical guidelines.	Procedure: breast resection; breast resection without sentinel lymph node biopsy, radiotherapy to the breast area and sentinel lymph nodes
Active Comparator: Group 1: Breast resection with biopsy of the sentinel lymph node, radiotherapy; 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.; 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.; Based on the postoperative histological findings, the patient is prescribed adjuvant systemic therapy in accordance with current clinical guidelines.	Procedure: Breast resection with sentinel lymph node biopsy; Breast resection with sentinel lymph node biopsy, radiotherapy to the breast and axilla according to current treatment standards

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2, 3, 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
locoregional recurrence-free survival	Compare locoregional recurrence-free survival in the study groups of patients with early breast cancer	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	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	3, 5 and 10 years

Collaborators and Investigators

• Sponsor: N.N. Petrov National Medical Research Center of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2023
• Primary Completion (Estimated): May 25, 2027
• Study Completion (Estimated): May 25, 2027

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: radiotherapy; early breast cancer; breast surgery; SLNB; refusal of Sentinel Lymph Node Biopsy; Mammolymphoscintigraphy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Cytological Techniques; Biopsy; Cytodiagnosis; Mastectomy; Diagnostic Techniques, Surgical; Lymph Node Excision; Mastectomy, Segmental; Sentinel Lymph Node Biopsy
• Other Study ID Numbers: 2417313; 24/173 (Other Identifier: N.N. Petrov National Medical Research Center of Oncology)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No