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 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT04101851
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent prior to breast-conserving surgery, including expected cooperation of the patients for follow-up, must be obtained and documented according to the European regulatory requirements
* Histologically confirmed unilateral primary invasive carcinoma of the breast (core biopsy). Multifocal or multicentric tumors are allowed if breast-conserving surgery is planned.
* Age at diagnosis at least 18 years
* imaging techniques with estimated tumor stage between cT1-T3 prior to NAST
* triple-negative or HER2-positive invasive breast cancer
* clinically and sonographically tumor-free axilla prior to core biopsy (cN0/iN0)
* in cases with cN0 and iN+, a negative core biopsy or fine needle aspiration (FNA) biopsy of the sonographically suspected lymph node is required
* no evidence for distant metastasis (M0)
* standard NAST with radiologic complete response (rCR)
* planned breast-conserving surgery with postoperative external whole-breast irradiation (conventional fractionation or hypofractionation)
Exclusion Criteria:
* History of malignancy within last 5 years, except curatively treated basalioma of the skin and carcinoma in situ of the cervix
* Time since last cycle of NAST \>3 months (optimal \<1 month)
* histologically non-invasive breast carcinoma before NAST
* ER-positive (\>=10% positive cells on IHC)/HER2-negative disease (triple-positive tumors are allowed)
* cT4 or iT4 tumors
* pregnant or lactating patients
* no radiologic complete response at the end of NAST
* planned total mastectomy after NAST
* planned intraoperative radiotherapy (e.g. Intrabeam) or postoperative partial breast irradiation (e.g. multicatheter technique) alone; both procedures are allowed as boost techniques
* male patients
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04101851
Study Brief:
Protocol Section:
NCT04101851