Tests nivolumab with chemotherapy in triple negative breast cancer that has spread
Tests nivolumab with chemotherapy in adults with spreading triple negative breast cancer.
Plain-language title generated from the registry record
Registry title: Immune Induction Strategies to Improve Response to Immune Checkpoint Blockade in Triple Negative Breast Cancer (TNBC) Patients
Key facts
- Where
- Amsterdam, NetherlandsSee the site
- Phase
- Phase 2
Where in Netherlands
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingAmsterdam, NetherlandsNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Netherlands Cancer Institute
- Trial code
- NCT04159818EU 2024-513217-12-00
- Record updated
- 22 March 2022
- Original description
This is a single center non-blinded randomized multi-cohort non-comparative phase II trial with a Simon's two-stage design.Read full original descriptionShow less
Immune Induction Strategies to Improve Response to Immune Checkpoint Blockade in Triple Negative Breast Cancer (TNBC) Patients: the TONIC-2 Trial
This is a single center non-blinded randomized multi-cohort non-comparative phase II trial with a Simon's two-stage design.
Inclusion: Metastatic or incurable locally advanced triple negative breast cancer (ER < 10%, HER2 IHC 0,1+ or 2+ with no amplification); Metastatic lesion accessible for histological biopsy; 18 years or older; Maximum of three lines of chemotherapy for metastatic disease and with evidence of progression of disease. Treatment with low-dose doxorubicin in the palliative setting is not allowed; WHO performance status of 0 or 1; Measurable or evaluable disease according to RECIST 1.1; Disease Free Interval (defined as time between first diagnosis or locoregional recurrence and first metastasis) longer than 1 year; Subjects with brain metastases are eligible if these are not symptomatic and free of progression of at least 4 weeks; A maximum dosage of 360 mg/m2 of anthracyclines and no previous anthracycline-related cardiac toxicity. In case of radiation in the cardiac area, hypertension, diabetes mellitus or hypercholesterolemia, the left ventricular ejection fraction must be 50% or higher; Adequate bone marrow, kidney and liver function.
Exclusion: history of having received other anticancer therapies within 2 weeks of start of the study drug; prior treatment with immune checkpoint inhibitors; uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris; known history of leptomeningeal disease localization; history of immunodeficiency, autoimmune disease, conditions requiring immunosuppression (>10 mgl daily prednisone equivalents) or chronic infections; active other cancer; history of uncontrolled serious medical or psychiatric illness; current pregnancy or breastfeeding.