Status:
RECRUITING
Pre-operative Trial for Breast Cancer With Nivolumab in Combination With Novel IO
Lead Sponsor:
The Netherlands Cancer Institute
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
The investigators aim to test the activity of nivolumab monotherapy in primary breast tumors in a pre-operative window of opportunity trial. As the data of the investigators generated in the TONIC tri...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
Key Trial Info
Start Date :
October 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2033
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03815890
Start Date
October 4 2019
End Date
January 1 2033
Last Update
May 30 2024
Active Locations (1)
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1
NKI-AVL
Amsterdam, Netherlands, 1066CX