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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT02364960
Eligibility Criteria:
Inclusion Criteria:
* Female
* Age 45 or greater
* Diagnosed with operable invasive breast cancer, T1 and T2 (\< 3.5 cm), N0, M0, confirmed by cytological or histological examination
* Suited for breast conserving surgery
* Have had an ipsilateral (same side as current cancer) diagnostic mammogram within 12 months of enrollment
Exclusion Criteria:
* age 44 or less
* Axillary lymph node positive breast cancer
* Invasive lobular cancer
* Tumor size \> 3.5 cm
* Extensive Intraductal Component (EIC= \> 25% of the lumpectomy specimen involved with ductal carcinoma in situ, DCIS) as assessed on surgical pathologic lumpectomy specimen
* Multicentric cancer in the same breast not amenable to excision with a single lumpectomy
* Inability to assess pathologic margin status
* Synchronous bilateral breast cancer at the time of diagnosis.
* Ipsilateral breast had a previous cancer and/or prior in-field radiation.
* Patients known to have BRCA1/2 gene mutations
* Neoadjuvant treatment (hormones or chemotherapy)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Study:
NCT02364960
Study Brief:
Protocol Section:
NCT02364960