Actively Recruiting
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)
Led by N.N. Petrov National Medical Research Center of Oncology · Updated on 2022-06-15
60
Participants Needed
1
Research Sites
478 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged over 18 years and up to 70 years
- Diagnosed with triple negative or HER2-positive breast cancer (ER/PR +/-)
- Breast cancer stage IIA to IIIA
- ECOG performance status 0 or 1
- Life expectancy longer than 3 months
- Agree to use reliable contraception throughout the study
- Adequate liver and bone marrow function
- No contraindications to surgery including acceptable anesthetic risk
You will not qualify if you...
- Do not meet the inclusion criteria
- Previous systemic therapy for breast cancer
- Stage IV breast cancer
- Carry BRCA1 or BRCA2 gene mutations
- Severe uncontrolled chronic or acute diseases
- Presence of a second malignant tumor
- Pregnant or breastfeeding
- Acute conditions or complications interfering with treatment as judged by a doctor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Petr Krivorotko
Saint Petersburg, Russia, 197758
Actively Recruiting
Research Team
P
Petr Krivorotko, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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