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:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT03710733
Eligibility Criteria:
Inclusion Criteria:
* Histopathologically proven breast cancer resected by lumpectomy
* Female patient
* Invasive breast cancer
* Negative surgical margin
* Age \< or equal 50 years, or high-grade irrespective of age
* Appropriate stage for protocol entry i.e. no metastasis
* Performance Status 0-2
* Hormone receptor status:
1. ER/PR Known
2. Borderline results are considered positive
Exclusion Criteria:
* Metastatic patients
* Paget's disease of nipple
* Non-epithelial breast malignancy e.g. sarcoma, lymphoma
* Unresected suspicious microcalcifications in the same or contralateral breast
* Pregnant women
* Inability to delineate lumpectomy cavity
* Psychiatric or addictive disorders rendering treatment or follow-up difficult
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT03710733
Study Brief:
Protocol Section:
NCT03710733