C50.9
Conditions
Interventions
Group 1: Patients are included according to the inclusion criteria. The details about the study as well as potential risks and side effects of the study and of the diagnostic procedures are thoroughly
Sponsors
Klinikum der Universität München, Campus Großhadern
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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+
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Higher diagnostic accuracy of PERCIST 1.0 compared to iRECIST and of PECRIT compared to iRECIST in predicting clinical benefit for the patients 9-12 weeks after therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Stromal TILs, if available, measured as percentage of immune cells in stromal tissue within the tumour that showed a mononuclear immunological infiltrate Stromal TILs will be analysed as a continuous measurement, as well as using predefined categories: low TILs (0–10%), intermediate TILs (11–59%), or high TILs (60–100%). Expression of PD-L1, analysed via immunohistochemistry in pre-treatment and if applicable in post-treatment tumor tissues achieved by core-biopsy Predefined PD-L1categories are: negative (less than 1%), low (1–49%) or high (at least 50%). Different subsets of CD8+ memory effector cytotoxic T cells (e.g. Immune effector (CD3+CD4–CD8+CD45RA– CD45ROhiCD27–CCR7– cells)), analyzed via flow cytometry at different time point Amount of specific CTCs, identified as EpCAM(+)DAPI(+)CK(+)CD45(-), circulating in the blood at different time points Level of circulating exosomal PD-L1 during treatment at different time points Multi-variate parameter fusion approach: prognostic value of a combined, high-dimensional modeling approach using semantic image features, clinical and metabolic parameters Progression free survival Overall survival | — |
Countries
Germany
Contacts
Public ContactClemens Cyran
Klinikum der Universität München
Outcome results
None listed