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Refusal of Breast Surgery in Patients With Breast Cancer With a Clinical Complete Response (cCR) After Neoadjuvant Systemic Therapy and a Confirmed Pathological Complete Response (pCR) Using Vacuum-assisted Biopsy (VAB) and Sentinel Lymph Node Biopsy (SLNB)

RecruitingNAAges 18 Years - 70 YearsFemaleN.N. Petrov National Medical Research Center of O…
NCT04293796 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The main goal of the study is to abandon breast surgery in patients with breast cancer with a clinical complete response (cCR) after neoadjuvant systemic therapy and confirmed pCR using Vacuum-assisted biopsy (VAB) and sentinel lymph node biopsy (SLNB). Evidence of the high diagnostic accuracy (sensitivity and specificity) of vacuum aspiration biopsy in determining pCR in patients with clinical complete response after neoadjuvant systemic therapy will allow abandoning breast surgery in favor of radiation therapy alone, improving the quality of life of these patients.

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📋 Eligibility rules (as published)
Inclusion Criteria: Triple negative breast cancer / HER2-positive breast cancer (ER / PR +/-) * age\> 18 years. * morphologically confirmed diagnosis of breast cancer, IIA-IIIA stage * ECOG score 0-1. * life expectancy of more than 3 months. * the consent of patients to use reliable methods of contraception throughout the study * adequate liver and bone marrow function * the absence of contraindications to surgical intervention (including anesthetic risk is taken into account). Exclusion Criteria: * Inconsistency with inclusion criteria. * Conducting earlier any systemic therapy for breast cancer. * stage 4 cancer * carrier mutations of the BRCA1 / 2 gene * severe uncontrolled concomitant chronic diseases or acute diseases * the presence of a second malignant tumor * pregnancy or lactation * acute conditions and complications, which, according to the doctor, interfere with treatment
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What it tests

  • Vacuum-assisted biopsy
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Where

1 site
Petr Krivorotko
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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