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

Recruiting now · Not applicable

Conditions studied: Early Breast Cancer

In brief

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.

Key facts

Study ID

NCT07579286

Run by

N.N. Petrov National Medical Research Center of Oncology

People needed

100

Starts

2023-07-27

Expected to finish

2027-05-25

Last updated by the study team

2026-05-12

Who can join

Age: 60 and older. Sex: female. Healthy volunteers: not accepted.

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…

• 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
• pregnancy

Where it is running

• N.N. Petrov National Medical Research Center of Oncology — Saint Petersburg, Russian Federation, Russia (enrolling)

Full record on ClinicalTrials.gov

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