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 @ 9:55 PM
Ignite Modification Date:
2025-12-24 @ 9:55 PM
NCT ID:
NCT06909032
Eligibility Criteria:
Inclusion Criteria:
* Aged greater than or equal to 50 years old
* Histologically confirmed Infiltrating ductal carcinoma (IDC) or pure DCIS, less than or equal to 20mm maximum size.
* Lobular carcinoma in situ (LCIS) is permitted.
* Histologic grade I or II
* Estrogen receptor (ER) +/- progesterone receptor (PR) positive in greater than or equal to 10% of cells and HER2 receptor-negative.
* Tumour bed identifiable on imaging via surgical clips
* Clear surgical margins
* Sentinel nodes negative (at least one node taken if invasive and no isolated tumour cells)
* No evidence of distant metastasis
Exclusion Criteria:
* Ink on surgical margins or positive histological margins
* Lymphatic vessel invasion (LVI)
* Bilateral breast cancer
* Invasive lobular carcinoma
* Pleomorphic LCIS
* Multifocal or multicentric invasive cancer
* Invasive carcinoma with associated DCIS greater than or equal to 30mm.
* Patients receiving neoadjuvant chemotherapy, anti-HER2 agents or endocrine therapy
* Patients receiving adjuvant chemotherapy or anti-HER2 agents.
* Previous Hodgkin's lymphoma requiring mantle radiation
* Prior radiation therapy to the ipsilateral breast
* Triple-negative breast cancer
* Documented mutation of BRCA1, BRCA2 or TP53, or at high genetic risk of breast cancer
* Known inflammatory conditions associated with higher complications after RT, such as active scleroderma, systemic lupus erythematosus (requiring steroids or immune suppressive therapy)
* Oncoplastic surgery where the primary tumour site is difficult to delineate
* No previous cancer (except BCC or SCC of the skin) unless in remission beyond five years of diagnosis
* People who are pregnant or planning to become pregnant
* People who are unable or unwilling to comply with protocol requirements.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Study:
NCT06909032
Study Brief:
Protocol Section:
NCT06909032