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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07398118
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 70 years
* Histologically confirmed invasive breast cancer
* Clinical stage cT1N0M0 based on mammography and ultrasound ER-positive, HER2-negative (IHC 0-1+ or 2+ with negative ISH), any PR status
* Presence of concurrent DCIS is allowed if limited to \<25% of the pre-NST biopsy, with no radiologic suspicion of an extensive component
* Unifocal disease \<2 cm, well visualized on ultrasound, with a minimum distance of ≥5 mm from the skin, nipple and thoracic wall
* Ability and willingness to comply with project requirements
* Preoperative endocrine therapy is allowed
* Written informed consent given by the subject
Exclusion Criteria:
* Pure DCIS lesions without invasive component
* Extensive calcifications on imaging suggestive of widespread disease
* Invasive lobular carcinoma (as assessed by IHC)
* Triple-negative or HER2-positive subtype (defined as (IHC 3+ or ISH positive)
* History of ipsilateral breast cancer or DCIS
* Prior ipsilateral radiotherapy
* Inability to communicate in Dutch or English language
* Planned (e)migration or long-term stay abroad within one year after inclusion
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
70 Years
Study:
NCT07398118
Study Brief:
Protocol Section:
NCT07398118