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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT02212860
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 50 years and postmenopausal
* Tumor size \< 3cm on pre-treatment imaging
* Any grade of disease, estrogen receptor (ER) positive
* Unicentric/unifocal disease
* Invasive ductal carcinoma or other favorable subtypes of epithelial breast malignancy (lobular, medullary, papillary, colloid, mucinous, or tubular) .
* Clinically node-negative (based upon pre-treatment physical examination and/or axillary ultrasound).
* Surgical expectation that a \> 2mm margin can be obtained.
* Lesion is 1 cm or greater from the skin surface.
* Able to have surgery within 14-20 days of radiation therapy.
* Able to lie comfortably in the prone position with arms raised above the head for extended periods of time.
Exclusion Criteria:
* Previous RT to the same breast
* Evidence of suspicious diffuse microcalcifications in the breast prior to the start of radiation.
* Local metastatic spread into ipsilateral axilla and/or supraclavicular region and/or neck nodes and/or internal mammary nodes diagnosed on clinical examination or any imaging assessment (unless such sites can be confirmed as negative following biopsy)
* Distant metastases
* Involvement of contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes (unless there is histologic confirmation that these nodes are negative)
* Prior non-hormonal therapy or radiation therapy for the current breast cancer
* Patients with Paget's disease of the nipple.
* Skin involvement, regardless of tumor size.
* Patients with a breast technically unsatisfactory for radiation therapy.
* Inability to lie prone with arms raised above head for extended periods of time.
* Patients not appropriate for breast conserving surgery due to expectation of poor cosmetic result, even without RT
* Collagen vascular disease (particularly lupus, scleroderma, dermatomyositis)
* Inability or unwillingness to provide informed consent.
* Any other malignancy at any site (except non-melanomatous skin cancer) \< 5 years prior to study enrollment
* Patients who are pregnant or lactating
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Study:
NCT02212860
Study Brief:
Protocol Section:
NCT02212860