Abandoning breast surgery for certain breast cancer patients after successful treatment
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)
Run by N.N. Petrov National Medical Research Center of Oncology · NCT04293796 · Data updated 2026-11-12
This study is testing if some breast cancer patients who have no signs of cancer after treatment can skip surgery and just have radiation instead.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | N.N. Petrov National Medical Research Center of Oncology Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Saint Petersburg) |
| Status | Recruiting |
| Started | October 8, 2019 |
| Main results expected | December 10, 2027 |
| Study ends | December 10, 2028 |
| Registry record updated | June 15, 2022 |
| Trial ID | NCT04293796 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with triple-negative or HER2-positive breast cancer at stages IIA to IIIA who have achieved a clinical complete response after neoadjuvant therapy.
✕Probably not a fit
Patients with stage 4 cancer, those who have undergone prior systemic therapy for breast cancer, or individuals with severe uncontrolled chronic diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the feasibility of forgoing breast surgery in patients with breast cancer who achieve a clinical complete response (cCR) after neoadjuvant systemic therapy and confirm a pathological complete response (pCR) using vacuum-assisted biopsy (VAB) and sentinel lymph node biopsy (SLNB). The approach focuses on utilizing VAB to assess the absence of residual tumors, potentially allowing patients to receive radiation therapy alone instead of undergoing surgery. The study involves two main visits: one for informed consent and another for planning the VAB procedure, with the goal of improving patient quality of life and reducing the need for invasive surgical interventions.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the quality of life for breast cancer patients by eliminating the need for surgery.
How similar studies have gone: While this approach is innovative, similar studies exploring non-surgical interventions after neoadjuvant therapy have shown promising results, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: * 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's running
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Petr Krivorotko
Saint Petersburg, Russia Recruiting
Study contacts
- Principal investigator: Petr Krivorotko, MD,PhD — N.N. Petrov Research Institute of Oncology
- Study coordinator: Petr Krivorotko, MD,PhD
- Email: dr.krivorotko@mail.ru
- Phone: +79219597722
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.