Translational therapy monitoring of locally advanced or metastatic triple negative breast cancer (TNBC) with 18F-FDG PET-CT and liquid biopsy in immunotherapy
- Conditions
- C50.9Breast, unspecified
- Registration Number
- DRKS00024082
- Lead Sponsor
- Klinikum der Universität München, Campus Großhadern
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 30
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+
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method