Breast cancer
Conditions
Brief summary
pathological complete response rate per cohort, with a pCR defined as no residual invasively growing tumor cells detected by microscopic examination in breast and axilla.
Detailed description
incidence, nature and severity of Adverse Events graded according to NCI-CTCAE v5.0 collected during treatment and up to 3 weeks post-surgery., Radiological response using breast MRI per cohort, Event-free survival (EFS), Overall survival (OS), Immune activation after pre-operative nivolumab, either as monotherapy or in combination with ipilimumab or relatlimab or novel IO combinations
Interventions
DRUGCYCLOPHOSPHAMIDE
DRUGDoxorubicine HCl Hikma 2 mg/ml
DRUGPaclitaxel Fresenius Kabi
DRUGIPILIMUMAB
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
Sponsors
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate per cohort, with a pCR defined as no residual invasively growing tumor cells detected by microscopic examination in breast and axilla. | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence, nature and severity of Adverse Events graded according to NCI-CTCAE v5.0 collected during treatment and up to 3 weeks post-surgery., Radiological response using breast MRI per cohort, Event-free survival (EFS), Overall survival (OS), Immune activation after pre-operative nivolumab, either as monotherapy or in combination with ipilimumab or relatlimab or novel IO combinations | — |
Countries
Netherlands
Outcome results
None listed