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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT02065960
Eligibility Criteria:
Inclusion Criteria:
* Women age ≥ 70 years;
* New histological diagnosis of invasive carcinoma of the breast, grade I or II, estrogen and progesterone receptor (ER and PR) positive, HER2 negative on needle biopsy and limited to Stage I (T1 N0 M0) on clinical and radiological assessment with MRI of the breasts and axillary ultrasound;
* Candidate for breast conserving surgery;
* Signed study consent form completed prior to study entry.
Exclusion Criteria:
* Breast cancer with disease within 5 mm from skin or chest wall;
* Previous or concomitant invasive malignancies treated within 5 years of study entry;
* Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus or scleroderma), which would preclude to definitive radiation therapy;
* Psychiatric disorders, which would preclude from obtaining informed consent
* Geographic inaccessibility for follow-up
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
70 Years
Study:
NCT02065960
Study Brief:
Protocol Section:
NCT02065960