Immune induction strategies to improve response to immune checkpoint blockade in triple negative breast cancer (TNBC) patients: the TONIC-2 trial - TONIC-2 trial

ederlands Kanker Instituut0 个研究点目标入组 34 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•Metastatic or incurable locally advanced triple negative breast cancer (ER <
•10%, HER2 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.
•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. This does not
•apply to patients with de novo metastatic disease or patients who did not
•receive (neo)adjuvant chemotherapy.
•Subjects with brain metastases are eligible if these are not symptomatic and
•free of progression of at least 4 weeks

•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 having received other anticancer therapies within 2 weeks of start
•of the study drug
•history of immunodeficiency, autoimmune disease, conditions requiring
•immunosuppression (>10 mgl daily prednisone equivalents) or chronic infections.
•prior treatment with immune checkpoint inhibitors.

发起方

ederlands Kanker Instituut