Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer
NCT ID: NCT05914961
Last Updated: 2025-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
225 participants
OBSERVATIONAL
2024-06-01
2035-04-30
Brief Summary
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Detailed Description
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This study aims to investigate how inflammatory markers such as C-reactive protein (CRP) change during and after immunotherapy. Study findings from other tumor types (kidney, lung, bladder) suggest that immunotherapy is particularly effective when a mild inflammatory response is triggered in the body. The investigators want to examine this using CRP measurement. CRP measurement can easily be integrated into clinical routine as it only requires a blood sample. And since the patients already need a blood draw for chemotherapy, CRP measurement can be performed directly from the blood sample.
The goal of this prospective study is to determine whether changes in CRP levels in the blood can predict the disease progression or response to immunotherapy.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Control Group
Chemotherapy without immunotherapy
No interventions assigned to this group
Experimental Group
Chemotherapy in combination with immunotherapy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* histologically proven early or advanced or metastatic invasive breast cancer irrespective of therapy line
* ER-negative and progesterone receptor (PR)-negative and human epidermal growth factor receptor 2 (HER2)-negative (IHC 0-2+, Fluorescence In Situ Hybridization (FISH) neg.)
* patients with advanced or metastatic disease must be programmed cell death ligand 1 (PD-L1)-positive (IC ≥ 1 or combined positive score (CPS) ≥ 10) in the experimental group
* planned ICI therapy in combination with chemotherapy in the experimental group
* written informed consent into ICK-breast
Exclusion Criteria
* HER2-positive (IHC 2+, FISH pos or IHC 3+)
* any systemic breast cancer therapy before inclusion into the trial for early breast cancer patients
* any ICI therapy before inclusion into the trial
* pregnant or lactating patients
* inadequate general condition (not fit for chemotherapy)
18 Years
FEMALE
No
Sponsors
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University Hospital Ulm
OTHER
University Hospital Freiburg
OTHER
University Hospital Tuebingen
OTHER
Responsible Party
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Principal Investigators
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Tobias Engler, Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Women's Health Tübingen
Locations
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Department of Women's Health
Tübingen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ICK-Breast
Identifier Type: -
Identifier Source: org_study_id
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