Status:
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)
Lead Sponsor:
N.N. Petrov National Medical Research Center of Oncology
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
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief 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-assiste...
Detailed Description
Vacuum-assisted removal and biopsy of the tumor bed after neoadjuvant systemic therapy (NST) in patients with clinical complete clinical response with a biopsy of sientinel lymph nodes is in the futur...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- Inconsistency with inclusion criteria.
- 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
Key Trial Info
Start Date :
October 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04293796
Start Date
October 8 2019
End Date
December 10 2028
Last Update
June 15 2022
Active Locations (1)
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1
Petr Krivorotko
Saint Petersburg, Russia, 197758