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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2025-07-01 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 * Surgical margins that cannot be microscopically assessed * Extensive intraductal component (EIC+) * Extensive lymphovascular invasion (LVI+) (focal is allowed) * Triple negative breast cancer * BReast CAncer gene (BRCA) 1-2 mutation * Human Epidermal growth factor Receptor 2 positive (HER2+) patients not receiving postoperative anti-HER2 systemic therapy * Neoadjuvant systemic therapy * Paget's disease or pathological skin involvement * Synchronous or previous breast cancer. * Pregnant or lactating women
Contact & Investigator
Viktor Smanykó, MD
PRINCIPAL INVESTIGATOR
National Institute of Oncology, Budapest, Hungary
Frequently Asked Questions
Who can join the NCT07067437 clinical trial?
This trial is open to female participants only, aged 40 Years or older, studying Breast Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07067437 currently recruiting?
Yes, NCT07067437 is actively recruiting participants. Contact the research team at smanyko.viktor@oncol.hu for enrollment information.
Where is the NCT07067437 trial being conducted?
This trial is being conducted at Lyon, France, Nancy, France, Nice, France, Bremerhaven, Germany and 11 additional locations.
Who is sponsoring the NCT07067437 clinical trial?
NCT07067437 is sponsored by National Institute of Oncology, Hungary. The principal investigator is Viktor Smanykó, MD at National Institute of Oncology, Budapest, Hungary. The trial plans to enroll 250 participants.