Preoperative Breast Irradiation

Preoperative Breast Irradiation, the PROBI Trial. A Phase I/II Feasibility Trial

The PROBI is a phase I/II trial assessing the feasibility of preoperative whole breast irradiation in female patients with low to intermediate risk breast cancer, who undergo breast conserving therapy, including a boost dose of irradiation.

An additional goal of this study is to assess tumor response to radiotherapy, by imaging modalities (PET-CT and MRI) and pathology

Inclusion Criteria:

• Histologically proven invasive breast carcinoma
• cT1-2N0 breast cancer
• cM0
• female patients ≤ 50 years
• planned breast conserving surgery
• ability to undergo irradiation and surgery
• signed written informed consent

Exclusion Criteria:

• prior surgery or radiotherapy for the protocol tumor (neoadjuvant chemotherapy or endocrine therapy is allowed)
• planned oncoplastic reduction mammoplasty
• cTis
• extensive calcifications on mammagram (Birads 3,4 or 5)
• cT3-4 and/or cN1-3 invasive carcinoma
• distant metastasis