Refusal of Sentinel Lymph Node Biopsy in Patients With Luminal A Subtype Early Breast Cancer
Recruiting · NCT07579286 · Interventional (participants receive a specific treatment) · Lead sponsor: N.N. Petrov National Medical Research Center of Oncology
View the official record on ClinicalTrials.gov →Interventions studied
Breast resection with sentinel lymph node biopsybreast resection
What this trial is about
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.
Who can take part
Age range
60 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
1 location listed.
- N.N. Petrov National Medical Research Center of Oncology - Saint Petersburg, Russian Federation, Russia