C50
Conditions
Interventions
Group 1: One prospective, monocentric observational cohort of patients with histologically confirmed triple-negative breast cancer scheduled to receive pembrolizumab-based neoadjuvant immunochemothera
Sponsors
Universitätsklinikum Würzburg Frauenklinik und Poliklinik Josef-Schneider-Straße 4, Haus C15 97080 Würzburg Deutschland
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Eligible patients are women aged 18 years or older who have provided written informed consent and have histologically confirmed triple-negative breast cancer, defined as hormone receptor-negative and HER2-negative according to current pathological standards. An indication for pembrolizumab-based neoadjuvant immunochemotherapy according to tumor board or CCC standard must be present. Patients must be clinically stable and suitable for blood sampling and standard clinical treatment.
Exclusion criteria
Exclusion criteria: Patients will be excluded if they are unable to provide informed consent or do not provide written informed consent, if they are pregnant or breastfeeding, or if study-related blood sampling is not clinically appropriate. Further exclusion criteria include relevant acute infections or systemic anti-infective treatment that may substantially interfere with immune assays, uncontrolled autoimmune disease, relevant systemic immunosuppression, prior checkpoint inhibition if excluded by the final protocol, and severe hypersensitivity to the planned standard therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the association between serum GDF-15 and functional LFA-1 activation in lymphocytes and pathological treatment response after neoadjuvant pembrolizumab-based immunochemotherapy. Pathological treatment response will be assessed using the surgical and pathological reports after completion of neoadjuvant therapy, with particular evaluation of pathological complete response versus non-pathological complete response. Biomarkers will be assessed longitudinally using serum and fresh heparinized whole blood, particularly before the first pembrolizumab/chemotherapy administration, during neoadjuvant therapy, before the last planned neoadjuvant treatment, and after treatment completion, where available. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include longitudinal changes in serum GDF-15 and LFA-1 activity during treatment; correlations of these biomarkers with residual cancer burden, ypT/ypN stage, residual tumor, and tumor immunological parameters (including T-cell activation markers and T-cell infiltration); baseline clinicopathological parameters; and progression-free or event-free survival. Further secondary analyses include the association of these biomarkers with recurrence, metastasis, treatment discontinuation, treatment change, and clinical outcome during follow-up. | — |
Countries
Germany
Contacts
Public ContactMarzieh Weich
Universitätsklinikum Würzburg (UKW) Frauenklinik und Poliklinik
Outcome results
None listed