ConditionBreast Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40+
SponsorNational Institute of Oncology, Hungary
About this trial
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
Qualifiers
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)
Disqualifiers
Stage III-IV breast cancer
Surgical margins that cannot be microscopically assessed
Extensive intraductal component (EIC+)
Extensive lymphovascular invasion (LVI+) (focal is allowed)
Trial design
Treatments tested in this trial
- single-fraction very accelerated partial breast irradiation
Treatment groups
250 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov