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 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT03789851
Eligibility Criteria:
Inclusion Criteria:
* after full-course neoadjuvant chemotherapy (NAC) according to the NACT protocol
* with cT1c-cT4a-c tumors
* after informed consent
* with breast ultrasound, mammography (and breast MRI where necessary) before and after NACT
* Clinical / imaging partial or complete response to NAC
* Any routine breast cancer surgical intervention planned according to guidelines (breast conservation or mastectomy)
* Residual intramammary target lesion or clip marker is visible in ultrasound and / or mammography
* Inclusion of only one breast per patient, in bilateral cancer one breast can be included
* In case of multicentric disease: confirmation of the same tumorbiological subtype defined by immunohistology in at least 2 lesions.
Exclusion Criteria:
* Palliative or recurrent breast cancer
* Pregnancy and lactation
* cT4d stage (inflammatory breast cancer)
* M1 stages
* stable disease according to a multimodal assessment of ultrasound, mammography and breast MRI (if available) according to RECIST
* dislocation of marker (\> 10mm distance to the initial lesion)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03789851
Study Brief:
Protocol Section:
NCT03789851