Pre-operative Trial for Breast Cancer With Nivolumab in Combination With Novel IO

Exclusion Criteria

• •evidence or suspicion of metastatic disease. Evaluation of the presence of distant metastases may include chest X-ray, liver ultrasound, isotope bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local procedures;
• •evidence of a concurrent contralateral or ipsilateral second primary infiltrating breast cancer. Evaluation of the presence of a concurrent second primary breast cancer may include mammography, breast ultrasound and/or MRI breast;
• •other malignancy except carcinoma in situ and basal-cell and squamous carcinoma of the skin, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiotherapy
• •previous radiation therapy or chemotherapy;
• •prior treatment with checkpoint inhibitors (including anti- PD1, -PD-L1, -CTLA-4);
• •concurrent anti-cancer treatment, neoadjuvant therapy or another investigational drug;