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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT03043794
Eligibility Criteria:
Inclusion Criteria:
* Female sex
* Age \> or = to 50 years of age
* Invasive ductal carcinoma
* Clinically and radiographically T1 tumor
* Clinically node negative
* Clearly demarcated tumor on magnetic resonance imaging (MRI), as determined by treating physician (MRI may be done after enrollment if not done prior)
* Planning breast conserving surgery including sentinel node biopsy
* ≥10% expression of ER and/or PR
* HER2- using the current College of American Pathologists guidelines
* Post-menopausal
* Willing and able to provide informed consent
Exclusion Criteria:
* Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma
* Pure DCIS without invasive cancer
* Patients who have received or will be receiving neoadjuvant systemic therapy, endocrine therapy, or targeted agents
* Breast implant in the involved breast unless the implant will be removed prior to initiation of study treatment
* Positive pregnancy test
* Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement.
* Unable to meet dosimetric constraints due to tumor location and/or patient anatomy
* Planning mastectomy
* Unable to tolerate prone positioning
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
100 Years
Study:
NCT03043794
Study Brief:
Protocol Section:
NCT03043794