TNBC - Triple-Negative Breast CancerNCT05914961
Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer
An observational study of TNBC - Triple-Negative Breast Cancer, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- TNBC - Triple-Negative Breast Cancer
- How many people
- 225 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2024to Apr 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Women's Health
Tübingen, 72076
Tobias Engler, Dr., 07071 29 82211, Tobias.Engler@med.uni-tuebingen.de
About this study
Official title: ICK-Breast: Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer
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.
Read the 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.
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Chemotherapy without immunotherapy | |
| Experimental Group | Chemotherapy in combination with immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic value of CRP kinetics under ICI therapy on pathologic complete response (PCR)
Evaluation of CRP kinetics to predict pCR in early (pathologic complete response) TNBC treated with ICI in combination with chemotherapy. The CRP value is determined from blood samples.
Measured: duration of therapy and follow-up data (10 years)
Secondary outcomes (1)
Prognostic value of CRP kinetics under ICI therapy on objective response rate (ORR), progression free survival (PFS), event-free survival (EFS), invasive recurrence free survival and overall survival (OS)
- evaluation of CRP kinetics to predict objective response in patients with metastatic TNBC receiving ICI in combination with chemotherapy
- evaluation of CRP kinetics to predict progression free survival in patients with metastatic TNBC receiving ICI in combination with chemotherapy
- evaluation of CRP kinetics to predict overall survival in patients with metastatic TNBC receiving ICI in combination with chemotherapy
- evaluation of CRP kinetics to predict event-free survival in patients with early TNBC receiving ICI in combination with chemotherapy
- evaluation of CRP kinetics to predict distant invasive recurrence free survival in patients with early TNBC receiving ICI in combination with chemotherapy The CRP value is determined from blood samples.
Measured: duration of therapy and follow-up data (10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jun 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBC - Triple-Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Ulm, University Hospital Freiburg
- Responsible party
- Sponsor
- Investigators
- Tobias Engler, Dr., Principal investigator, Department of Women's Health Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914961
- Sponsor's protocol ID
- ICK-Breast
- Status last verified
- Apr 2025
- First submitted
- 13 Jun 2023
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICK-Breast: Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05914961
- Acronym / sponsor ID
- ICK-Breast
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- University Hospital Ulm, University Hospital Freiburg
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2035 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Chemotherapy without immunotherapy |
| Experimental Group | – | –Chemotherapy in combination with immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prognostic value of CRP kinetics under ICI therapy on pathologic complete response (PCR)
Time frame: duration of therapy and follow-up data (10 years)
Evaluation of CRP kinetics to predict pCR in early (pathologic complete response) TNBC treated with ICI in combination with chemotherapy. The CRP value is determined from blood samples.
1 secondary outcome
Prognostic value of CRP kinetics under ICI therapy on objective response rate (ORR), progression free survival (PFS), event-free survival (EFS), invasive recurrence free survival and overall survival (OS)
Time frame: duration of therapy and follow-up data (10 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tobias Engler, Dr. principal investigator
Department of Women's Health Tübingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TNBC - Triple-Negative Breast Cancer, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tobias Engler, Dr. (07071 29 82211, Tobias.Engler@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic value of CRP kinetics under ICI therapy on pathologic complete response (PCR) (time frame: duration of therapy and follow-up data (10 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.