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

RecruitingNAAges 60 Years - anyFemaleN.N. Petrov National Medical Research Center of O…
NCT07579286 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • breast resection
  • Breast resection with sentinel lymph node biopsy
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Where

1 site
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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