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RecruitingNot ApplicableNCT04293796

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)

Sponsor

N.N. Petrov National Medical Research Center of Oncology

Enrollment

60 participants

Start Date

Oct 8, 2019

Study Type

INTERVENTIONAL

Conditions

Refusal of Breast Surgery in Patients With Breast Cancer With a cCR After NST and a Confirmed Pathological Complete Response (pCR) Using VAB and SLNB

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria15

  • 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).
  • 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

Interventions

PROCEDUREVacuum-assisted biopsy

The vacuum-assisted (7-10G), minimal invasive biopsy (VAB), either guided by ultrasound, after neoadjuvant systemic treatment on patients with clinical complete response on primary breast cancer management we recommend to take at least 12 biopsies with 7-10G needle sizes with sentinel lymph node biopsy.

Locations(1)

Petr Krivorotko

Saint Petersburg, Russia

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NCT04293796