Translational therapy monitoring of locally advanced or metastatic triple negative breast cancer (TNBC) with 18F-FDG PET-CT and liquid biopsy in immunotherapy - TNBC_ICI_PET CT

Klinikum der Universität München, Campus Großhadern0 个研究点目标入组 30 人开始时间: 2021年7月30日最近更新: 2024年8月19日

适应症

试验速览

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•Age 18 years or older
•Histologically documented, unresectable, locally advanced or metastatic TNBC
•Life expectancy of at least 12 weeks
•HER2-negative, estrogen receptor-negative, and progesterone receptor-negative status evaluation by local institutions before enrolment
•Patients need to provide representative tumour specimens that are evaluable for prospective testing of PD-L1 expression by immunohistochemistry
•Assessment of CPS score and TMB
•No previous chemotherapy or targeted therapy for metastatic triple negative breast cancer
•At least 1 lesion that could be accurately measured in at least 1 dimension with spiral CT scanning according to RECIST 1.1
•Adequate organ and hematological function.
•Radiotherapy and previous curative chemotherapy needs to be completed 12 months or more before inclusion

•Untreated CNS disease
•Previous history of autoimmune disease
•Recent treatment (ie, within 4 weeks or five half-lives of the drug [whichever was shorter] with a systemic immunostimulatory drug)
•Use of glucocorticoids or immunosuppressive drugs and previous immune checkpoint-targeting therapies.
•All other molecular subtypes, such as Luminal A, B, Her2+

发起方

Klinikum der Universität München, Campus Großhadern