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 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT04223492
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven invasive breast carcinoma
* Planned for neoadjuvant chemotherapy (and in case of a Her2-positive tumor: addition of trastuzumab and/or pertuzumab)
Exclusion Criteria:
* Luminal A breast cancer (defined as: ER-positive and HER2-negative by immunohistochemistry and Bloom and Richardson grade 1 or 2)
* Inflammatory breast cancer
* Distant metastases on PET/CT
* Other active malignant disease in the past 5 years (excluded squamous cell or basal cell carcinoma of the skin)
* Pregnant or lactating women
* Contra-indications for MRI according to standard hospital guidelines
* Contra-indications for gadolinium-based contrast-agent, including known prior allergic reaction to any contrast-agent, and renal failure, defined by GFR \< 30 mL/min/1.73m2
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04223492
Study Brief:
Protocol Section:
NCT04223492