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

This is an interventional treatment trial for Breast Cancer focused on measuring pre-operative, triple negative and Luminal B, resectable, stage I-III Read More

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%

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;