Refusal of Sentinel Lymph Node Biopsy in Patients With Luminal A Subtype Early Breast Cancer
N.N. Petrov National Medical Research Center of Oncology
100 participants
Jul 27, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria13
- 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.
- 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
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Interventions
breast resection without sentinel lymph node biopsy, radiotherapy to the breast area and sentinel lymph nodes
Breast resection with sentinel lymph node biopsy, radiotherapy to the breast and axilla according to current treatment standards
Locations(1)
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NCT07579286