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The safety and tolerability of treatment will be evaluated by means of dose-limiting toxicities, adverse events and serious adverse events reports, physical examinations, and laboratory safety evaluations. Dose-limiting toxicities are defined as a grade 4 fever, breast infection, skin ulceration or chest wall necrosis (according to CTCAE v5.0).
Adverse events will be coded according to the CTCAE Version 5.0. The results will be tabulated to examine their frequency, organ systems affected, grade, and relationship to study treatment.
This will be assessed through the quality of life questionnaires (questions on breast appearance and texture) and through the photo collection (pictures of the treated breast before/after NTP treatment).
Ex vivo or in situ treatment of cancerous and normal tissues with NTP followed by fixation of the tissues and analysis by immunofluorescence.
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