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)

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.

Trial Details

NCT ID

NCT04293796

Phase

NA

Sponsor

N.N. Petrov National Medical Research Center of Oncology

Status

RECRUITING

Cancer Type

Triple Negative (TNBC) Breast Cancer

Interventions

• Vacuum-assisted biopsy

Locations (sample)

• Saint Petersburg, Russia|59.93863,30.31413

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

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