Pre-operative Trial for Breast Cancer With Nivolumab in Combination With Novel IO
Recruiting now · Phase 2
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT03815890
- Run by
- The Netherlands Cancer Institute
- People needed
- 80
- Starts
- 2019-10-04
- Expected to finish
- 2033-01-01
- Last updated by the study team
- 2024-05-30
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
Where it is running
- NKI-AVL — Amsterdam, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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