NL-OMON54814
Recruiting
Phase 2
Pre-operative phase II trial for breast cancer with nivolumab in combination with novel IO (BELLINI trial) - BELLINI
ederlands Kanker Instituut0 sites90 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ederlands Kanker Instituut
- Enrollment
- 90
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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