NCT07067437 Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI)
| NCT ID | NCT07067437 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Oncology, Hungary |
| Condition | Breast Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2027-07-01 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
To investigate clinical outcomes, late side effects, and cosmetic results of a single-fraction very accelerated partial breast irradiation as postoperative local treatment for the treatment of early stage breast cancer.
Eligibility Criteria
Inclusion Criteria: * Stage 0 \& I \& II (\< 3 cm) breast carcinoma * Lesions of \< 3 cm diameter * Invasive carcinoma of any subtype and grade or ductal carcinoma in situ (DCIS) * Nodal status: node-negative (pN0) or micro-metastatic (pN1mi) (patients with pN1mi status can be treated, but due to the limited clinical evidence, individual decision is needed) * M0: Absence of distant metastasis * Clear resection margins by National Surgical Adjuvant Breast and Bowel Project (NSABP) definition (no tumor on ink) * Unifocal (multifocality limited within 2 cm) and unicentric breast cancer * Age\> 40 years * Luminal A or B tumors * Time interval from surgery preferably less than 12 weeks and no longer than 20 weeks, and from adjuvant chemotherapy less than 4 weeks * Human Epidermal growth factor Receptor 2 positive (HER2+) patients receiving postoperative anti-HER2 systemic therapy * Specific signed consent form prior to randomization Exclusion Criteria: * Stage III-IV breast cancer * Surgica