RecruitingOBSERVATIONAL

Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer

This research is investigating how a common blood marker, C-reactive protein (CRP), changes in women with triple-negative breast cancer who are receiving immunotherapy. Immunotherapy helps your body's own immune system fight cancer. The study aims to find out if changes in CRP levels can tell us how effective the treatment will be or how the cancer might develop. This could help doctors better understand how patients respond to their medication. It's for women aged 18 or older with forms of this breast cancer, and involves regular blood tests that often happen during typical chemotherapy appointments anyway.

At a glance

Status

Recruiting

Sponsor

University Hospital Tuebingen

Enrolment target

225

Start

01 Jun 2024

Estimated completion

01 Apr 2035

TNBC - Triple-Negative Breast Cancer

What is this study about?

This study is looking into a type of breast cancer called triple-negative breast cancer (TNBC). This specific type of cancer doesn't respond to some common treatments, but immunotherapy is proving to be a helpful option. Immunotherapy works by boosting your body's natural defence system (your immune system) to fight the cancer cells.

The main idea behind this study is to track how a substance in your blood, called C-reactive protein (CRP), changes when you're having immunotherapy. CRP levels often go up when there's inflammation in the body. Earlier studies in other cancers suggest that if immunotherapy causes a small amount of inflammation, it might be working well. Doctors want to see if the same is true for triple-negative breast cancer.

By regularly checking CRP levels through simple blood tests, which you might already be having for other treatments like chemotherapy, researchers hope to find out if changes in CRP can predict how well you'll respond to immunotherapy. This could help doctors understand sooner if the treatment is effective, or if the cancer is progressing, potentially leading to more personalised treatment plans in the future.

Key takeaways

This study investigates how CRP blood levels change during immunotherapy for breast cancer.
It focuses on triple-negative breast cancer (TNBC) patients.
The goal is to see if CRP changes can predict treatment success or disease progression.
Participation involves routine blood tests and medical data, not new treatments.
It aims to improve understanding and future treatment of TNBC.

Who may be eligible?

This study is looking for women who are 18 years old or older and have triple-negative breast cancer. This means your cancer cells don't have certain receptors (ER, PR, and HER2) that are present in other types of breast cancer.

If your cancer has spread (advanced or metastatic), you would also need to have a specific marker called PD-L1 present on your cancer cells. All participants must be planning to have immunotherapy combined with chemotherapy, and you can't have had immunotherapy before joining this study. Also, you shouldn't be pregnant or breastfeeding, and need to be well enough for chemotherapy treatment.

Basically, if your breast cancer is triple-negative, you're an adult woman, you're about to start immunotherapy combined with chemotherapy, and you meet a few other specific health requirements, you might be suitable for this research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 18 or older?
Do you have triple-negative breast cancer?
Are you about to start immunotherapy with chemotherapy for your breast cancer?
Have you not had immunotherapy before?
Are you not pregnant or breastfeeding, and generally well enough for chemotherapy?

Answer every question to see your result.

What does participation involve?

This study is non-interventional, which means you won't be given new or experimental medications as part of the research. Instead, you'll be receiving your standard immunotherapy and chemotherapy treatment as decided by your doctor. The main part of taking part in this study involves having your blood checked regularly for CRP levels. These blood samples will usually be taken at the same time as any blood tests you're already having for your chemotherapy or other routine appointments. You will also need to provide written permission for your medical information to be used for the study. The study will track how you respond to treatment over time, but it won't add extra clinic visits beyond your usual care.

Potential risks and benefits

Since this study doesn't involve new treatments, there are no additional direct medical risks beyond your standard cancer care. The main benefit is that you'll be contributing to important research that could help doctors better understand how immunotherapy works for triple-negative breast cancer, potentially improving future treatments for others. There's also a chance your doctors might gain earlier insights into how your own treatment is progressing. You are always free to leave the study at any time without affecting your medical care.

Locations (1)

Department of Women's Health
Verified postcode
Tübingen, Germany· Recruiting

Common questions

What is C-reactive protein (CRP)?

CRP is a substance made by your liver, and its levels in your blood go up when there's inflammation in your body. It's often checked during routine blood tests.

What is triple-negative breast cancer (TNBC)?

TNBC is a type of breast cancer where the cancer cells don't have certain 'receptors' that are targeted by some common cancer drugs. This makes it a bit different to treat.

What is immunotherapy?

Immunotherapy is a treatment that helps your body's own immune system find and fight cancer cells more effectively.

Will this study change my cancer treatment?

No, this study will not change your cancer treatment. You will receive the standard immunotherapy and chemotherapy your doctor has already prescribed for you.

Do I need extra blood tests for this study?

The study aims to use blood samples already being taken for your chemotherapy or routine check-ups, so you shouldn't need extra blood tests specifically for this research.

How to find out more

Tobias Engler, Dr.

tobias.engler@med.uni-tuebingen.de 07071 29 82211 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.