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 @ 11:48 AM
Ignite Modification Date:
2025-12-24 @ 11:48 AM
NCT ID:
NCT03643861
Eligibility Criteria:
Inclusion Criteria:
* Pathologically proven invasive mammary carcinoma, Invasive ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) of the breast. Medullary, papillary, mucinous (colloid) and tubular histologies are allowed.
* Age\>50.
* Maximum pathologic tumor size \<2.0cm if invasive carcinoma or \< 2.5cm if pure DCIS.
* Estrogen receptor (ER) positive (\>10%).
* Must be eligible for breast conservation therapy and receive a lumpectomy with pathologic margins of at least 2mm.
* Must be clinically node negative by physical examination. Sentinel node dissection is not required, but if undertaken, the patient must be pathologically node negative.
* Zubrod Performance Status 0-2.
Exclusion Criteria:
* Multifocal or multicentric cancer.
* Reception of neoadjuvant chemotherapy.
* Pure invasive lobular histology.
* Inability to clearly delineate lumpectomy cavity on post lumpectomy planning scan.
* Measured maximum PTV of \>124cc.
* Lumpectomy cavity within 5mm of body contour.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03643861
Study Brief:
Protocol Section:
NCT03643861