Breast Cancer Plasma Adjuvant Intra-operative Treatment (Breast Cancer PAINT)

Summary

The goal of this clinical trial is to test the safety of the use of non-thermal plasma (NTP, an ionized gas) on the tumor bed after the removal of the tumor in breast cancer patients. The main questions it aims to answer are: * To determine the safe and tolerable dose of NTP in patients with breast cancer; * To assess the safety and tolerability of NTP; * To assess the cosmetic effects of NTP treatment in patients with breast cancer. Participants will receive one treatment of the tumor bed after the removal of their breast tumor.

Eligibility

Inclusion Criteria:

1. Age ≥18 years at the time of signing study consent.
2. ECOG ≤2.
3. Patient with T1-4 breast cancer for groups A and B; patient with T1/T2 breast cancer for group C (based on physical exam, not radiological measurements).
4. Patient is scheduled to undergo a lumpectomy.

Exclusion Criteria:

1. Prior treatment for the tumor of interest (including chemotherapy, immunotherapy, radiotherapy).
2. Patient planning to or undergoing intraoperative radiotherapy.
3. Diabetes (types I and II).
4. Hypercortisolism.
5. Collagen vascular disease.
6. Patient requiring systemic corticosteroids at physiologic doses exceeding 10 mg/day of prednisone or its equivalent.
7. Patient receiving daily chemotherapy for rheumatological conditions.
8. Pregnancy (a urine pregnancy test must be obtained for non-sterile women of childbearing potential prior to surgery).

Conditions2

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