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

ConditionEarly Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age60+
SponsorN.N. Petrov National Medical Research Center of Oncology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • breast resection

    Procedure/Surgery

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

  • Breast resection with sentinel lymph node biopsy

    Procedure/Surgery

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Group 2:breast resection without sentinel lymph node biopsy, radiotherapy to the breast area and SLNExperimental treatment 1 intervention
Group B: Group 1: Breast resection with biopsy of the sentinel lymph node, radiotherapyActive comparator 1 intervention

Trial outcomes

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.

Time frame
2, 3, 5 years

Secondary outcomes

1

locoregional recurrence-free survival

Compare locoregional recurrence-free survival in the study groups of patients with early breast cancer

Time frame
5 and 10 years
2

overall survival and recurrence-free survival

Compare overall survival and recurrence-free survival in the study groups of patients with early breast cancer

Time frame
5 and 10 years
3

frequency and severity of adverse events

Compare the frequency and severity of adverse events, using the current version 5.0 of the CTCAE

Time frame
3, 5 and 10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

N.N. Petrov National Medical Research Center of Oncology

Lead sponsor

Source ClinicalTrials.gov
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