Short summary

This study examine the applicability of methylated ctDNA in the routine monitoring of treatment effect in newly diagnosed metastatic breast cancer patients. 

We will evaluate the potential of methylated ctDNA as an instrument to predict treatment response and progression-free survival in patients with newly diagnosed metastatic breast cancer treated with first line endocrine therapy +/- CDK-4-6-inhibitor. 

Rationale

The feasibility of plasma ctDNA in breast cancer is somewhat limited, since breast cancer is characterized by many different mutations.  Instead, methylation changes resulting in repression of tumor suppressor genes or activation of oncogenes could be a more consistent marker of tumor DNA. 

Several studies have shown the potential of ctDNA methylation as a prognostic tool in breast cancer with the gene methylation pattern predicting outcome. Furthermore, studies have shown association of methylated ctDNA with treatment response in metastatic breast cancer and the prediction of relapse.

Currently, no studies have examined the applicability of methylated ctDNA in the routine monitoring of treatment effect in newly diagnosed metastatic breast cancer patients. This prospective study will evaluate the potential of methylated ctDNA as an instrument to predict treatment response and progression-free survival in patients with newly diagnosed metastatic breast cancer treated with first line endocrine therapy +/- CDK-4-6-inhibitor. 

Description of the cohort

80 women with newly diagnosed metastatic breast cancer

Data and biological material

Clinical data: primary diagnosis of breast cancer and localizations of metastasees. 

Blood: plasma and serum

Collaborating researchers and departments

Department of Oncology, University Hospital of Southern Denmark, Vejle:

• Principal Investigator, MD Thomas Leth Fink
• Sponsor, Consultant Troels Bechmann, Postdoc
• Consultant Erik Hugger Jakobsen
• Professor Anders Jakobsen, DMSc

Department of Biochemistry and Immunology, University Hospital of Southern Denmark, Vejle:

• Head and Consultant Jonna Skov Madsen, PhD
• Molecular Biologist Rikke Fredslund Andersen