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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07579286
Acronym
LumiNOde
Enrollment
100
Registered
2026-05-12
Start date
2023-07-27
Completion date
2027-05-25
Last updated
2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Breast Cancer

Keywords

early breast cancer, radiotherapy, refusal of Sentinel Lymph Node Biopsy, SLNB, breast surgery, Mammolymphoscintigraphy

Brief 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.

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

Interventions

PROCEDUREbreast resection

breast resection without sentinel lymph node biopsy, radiotherapy to the breast area and sentinel lymph nodes

PROCEDUREBreast resection with sentinel lymph node biopsy

Breast resection with sentinel lymph node biopsy, radiotherapy to the breast and axilla according to current treatment standards

Sponsors

N.N. Petrov National Medical Research Center of Oncology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Axillary recurrence rate.2, 3, 5 yearsCompare 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.

Secondary

MeasureTime frameDescription
locoregional recurrence-free survival5 and 10 yearsCompare locoregional recurrence-free survival in the study groups of patients with early breast cancer
overall survival and recurrence-free survival5 and 10 yearsCompare overall survival and recurrence-free survival in the study groups of patients with early breast cancer
frequency and severity of adverse events3, 5 and 10 yearsCompare the frequency and severity of adverse events, using the current version 5.0 of the CTCAE

Countries

Russia

Contacts

CONTACTPetr Krivorotko, Degree
dr.krivorotko@mail.ru+79219597722
CONTACTArina Gorina
dr.arina_olegovna@mail.ru+79185374992

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026