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)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorN.N. Petrov National Medical Research Center of Oncology

About this trial

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.

Eligibility criteria

Qualifiers

age> 18 years.

morphologically confirmed diagnosis of breast cancer, IIA-IIIA stage

ECOG score 0-1.

life expectancy of more than 3 months.

Disqualifiers

Inconsistency with inclusion criteria.

Conducting earlier any systemic therapy for breast cancer.

stage 4 cancer

carrier mutations of the BRCA1 / 2 gene

Trial design

Treatments tested in this trial

  • Vacuum-assisted biopsy

Treatment groups

60 Participants
are divided into 2 treatment groups