Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-24 @ 12:37 PM
NCT ID:
NCT05914961
Eligibility 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)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05914961
Study Brief:
Protocol Section:
NCT05914961