Pre-operative Trial for Breast Cancer With Nivolumab in Combination With Novel IO
Recruiting
Phase 2
Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 80 (estimated)
- Sponsor
- The Netherlands Cancer Institute · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 s…