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Trial Title:
Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer
NCT ID:
NCT05914961
Condition:
TNBC - Triple-Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
ICK-breast is a prospective, multicentric, non-interventional investigator-initiated
trial (IIT) that aims to investigate the prognostic value of CRP kinetics in early and
advanced or metastatic triple negative breast cancer (TNBC) under immune checkpoint
inhibitor (ICI) therapy on pathological complete response (pCR) and event-free survival
in early TNBC patients, and objective response rate (ORR), progression-free survival
(PFS) and overall survival (OS) in advanced or metastatic TNBC.
Detailed description:
Immunotherapy, which involves activating the body's immune system for cancer treatment,
has already been widely incorporated into the standard care of breast cancer patients
with early and metastatic triple-negative breast cancer (TNBC).
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.
Criteria for eligibility:
Study pop:
225 patients will be included in the study after written informed consent. Of 75 patients
in the control group, which will undergo chemotherapy of physician's choice, 50 patients
will be diagnosed with early TNBC and 25 patients will be diagnosed with advanced or
metastatic TNBC.
Of 150 patients in the experimental group, which will undergo chemotherapy in combination
with ICIs, 100 patients will be diagnosed with early TNBC and 50 patients will be
diagnosed with advanced or metastatic TNBC.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- women ≥ 18 years of age
- 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:
- ER-positive or PR-positive
- 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)
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Women's Health
Address:
City:
Tuebingen
Zip:
72076
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Tobias Engler, Dr.
Phone:
07071 29 82211
Email:
Tobias.Engler@med.uni-tuebingen.de
Start date:
June 1, 2024
Completion date:
April 2035
Lead sponsor:
Agency:
University Hospital Tuebingen
Agency class:
Other
Collaborator:
Agency:
University Hospital Ulm
Agency class:
Other
Collaborator:
Agency:
University Hospital Freiburg
Agency class:
Other
Source:
University Hospital Tuebingen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05914961
