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)
Recruiting now · Not applicable
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT04293796
- Run by
- N.N. Petrov National Medical Research Center of Oncology
- People needed
- 60
- Starts
- 2019-10-08
- Expected to finish
- 2028-12-10
- Last updated by the study team
- 2022-06-15
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
Where it is running
- Petr Krivorotko — Saint Petersburg, Russia (enrolling)
Full record on ClinicalTrials.gov
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