Pre-operative phase II trial for breast cancer with nivolumab in combination with novel IO (BELLINI trial)

Phase 2

Recruiting

Conditions: breast cancer
pre-operative
10006291

Registration Number: NL-OMON54814

Lead Sponsor: ederlands Kanker Instituut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

• Resectable primary breast cancer stage I-III. Nodal status must be examined
by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan
(cohort 3B, 4B and 5B4: PET-CT mandatory).
- Patients indicated for neoadjuvant chemotherapy will also be eligible,
whereby a new dedicated biopsy is performed before the beginning of the
chemotherapy. Adjuvant systemic treatment is allowed if indicated according to
local guidelines.
• Tumor size at least 5 mm (minimum cT1b) 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, TNBC and TIL >=1%
- For cohort 4B: N0 status, TNBC and TIL >=30-49%
- For cohort 5B: N0 status, TNBC and TIL >=50%
• Age >=18
• WHO performance status <=1

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;
• other prior invasive malignancy 1) in the breast or 2) localized in the near
proximity of the breast, that was treated with radiotherapy at the
localization of the new breast tumor;
• Concurrent ipsilateral or contralateral disease of the primary or a secondary
tumor is allowed, as long as the other lesions is not a distant metastasis.
• Locoregional recurrences are not allowed. Second primary tumors are allowed
in the study;
• occult breast cancer;
• previous anti-cancer hormone therapy or chemotherapy;
• prior treatment with checkpoint inhibitors (including anti- PD1, -PD-L1,
-CTLA-4 - LAG3);
• concurrent anti-cancer treatment, neoadjuvant therapy or another
investigational drug;