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

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About this study

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.

Condition
TNBC - Triple-Negative Breast Cancer
Sponsor
University Hospital Tuebingen

Who can join

Age
18 years and older
Sex
Female only
Healthy volunteers
Not accepted

Inclusion 9

  • Minimum age: 18 years
  • Eligible sex: Female
  • Study condition: TNBC - Triple-Negative Breast Cancer
  • 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 6

  • 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)

Where

1 site, 1 recruiting

Department of Women's Health

Tübingen, Germany

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.