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

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

Plain Language Summary

Simplified for easier understanding

This trial is for women with triple-negative or HER2-positive breast cancer who had a complete response to pre-surgery chemotherapy — meaning no visible cancer remained. It tests whether a vacuum-assisted biopsy combined with sentinel lymph node surgery can confirm this complete response so accurately that the main breast surgery (lumpectomy or mastectomy) may be safely skipped. **You may be eligible if...** - You are over 18 years old - You have triple-negative or HER2-positive breast cancer at stage IIA to IIIA - Your cancer responded completely to pre-surgery chemotherapy on imaging - You are in good physical condition (ECOG 0-1) with adequate liver and bone marrow function - Your life expectancy is more than 3 months **You may NOT be eligible if...** - Your cancer did not have a complete response to chemotherapy - You have inflammatory breast cancer or distant metastases - You have contraindications to surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04293796