RecruitingPhase 2NCT03815890

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

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

Sponsor

The Netherlands Cancer Institute

Enrollment

80 participants

Start Date

Oct 4, 2019

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

To determine whether short-term pre-operative nivolumab either as monotherapy or in combination with low dose doxorubicin or novel IO combinations can induce immune activation in early BC.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria13

Signed written informed consent
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 Criteria6

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;