RecruitingNot ApplicableNCT07067437
Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI)
Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI) in Low-Risk Invasive or Ductal In Situ Breast Carcinoma - Phase II Multicenter Trial
Sponsor
National Institute of Oncology, Hungary
Enrollment
250 participants
Start Date
Jul 1, 2025
Study Type
INTERVENTIONAL
Conditions
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
Sex: FEMALEMin Age: 40 Years
Inclusion Criteria12
- 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 Criteria11
- 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
Interventions
RADIATIONsingle-fraction very accelerated partial breast irradiation
Adjuvant accelerated partial breast brachytherapy, with interstitial multicatheter technique, in one fraction.
Locations(22)
View Full Details on ClinicalTrials.gov
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NCT07067437
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