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

NCT07579286 | Recruiting DMC

• 2 other identifiers: 241731324/173
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• locoregional recurrence-free survival

  5 and 10 years

• overall survival and recurrence-free survival

  5 and 10 years

• frequency and severity of adverse events

  3, 5 and 10 years

Study Arms (2)

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.

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.

Procedure: Breast resection with sentinel lymph node biopsy

Interventions

breast resection PROCEDURE

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

Group 2:breast resection without sentinel lymph node biopsy, radiotherapy to the breast area and SLN

Breast resection with sentinel lymph node biopsy PROCEDURE

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

Group 1: Breast resection with biopsy of the sentinel lymph node, radiotherapy

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• \. pregnancy

Sponsors & Collaborators

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

Study Sites (1)

N.N. Petrov National Medical Research Center of Oncology

Saint Petersburg, Russian Federation, 197758, Russia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Segmental; Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Lymph Node Excision; Investigative Techniques

Central Study Contacts

Petr Krivorotko, Degree

CONTACT

+79219597722; dr.krivorotko@mail.ru

Arina Gorina

CONTACT

+79185374992; dr.arina_olegovna@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: July 27, 2023
• Primary Completion (Estimated): May 25, 2027
• Study Completion (Estimated): May 25, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

RU (1)