Clinical Research Directory

Inclusion Criteria: * Signed written informed consent * 18 years or older at moment of inclusion; * Female gender; * WHO performance status 0 or 1; * Resectable primary breast cancer stage I-III. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan. * The tumors must be: * at least 10 mm (minimum cT1c) as determined by MRI * TNBC defined as ER\<10%, HER2-negative OR luminal B defined as ER≥10%, HER2-negative with either Ki67≥20% or PR =\<20% OR grade 3. HER2 negative is defined as an IHC score of \<2 or 2+ with a negative ISH. * For TNBC patients: TIL≥5% * For LumB breast cancer patients: TIL≥1% * For cohort 3B: N0 status, TN and TIL ≥50% * For cohort 4B: N0 status, TNBC and TIL 30-49% * For cohort 5B: N0 status, TNBC and TIL ≥50% ● Patients with multifocal/multicentric breast cancer are eligible if triple negative breast cancer histology as well as sufficient TIL percentages (30-49% in cohort 4B, ≥50% in cohort 5B) have been confirmed in all tumor lesions. 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;