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 @ 7:21 PM
Ignite Modification Date:
2025-12-24 @ 7:21 PM
NCT ID:
NCT03422003
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosed with clinical or pathologic stage I-III invasive breast cancer with TX-T3 tumor
2. Has been treated with mastectomy
3. Has undergone immediate reconstructive surgery with placement of a tissue expander or permanent implant at time of mastectomy
4. Is a candidate for unilateral post-mastectomy radiation therapy as per National Comprehensive Cancer Network (NCCN) guidelines (post-mastectomy radiation therapy is indicated for most patients with positive lymph nodes at time of surgery and infrequently for selected node-negative patients)
5. Use of bolus is permitted, but not required
6. Age ≥18
Exclusion Criteria:
1. T4 cancer
2. Recurrent breast cancer or history of prior breast radiation therapy
3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and/or mental health illness that the consenting investigator feels would affect patient's ability to participate in this study
4. Pregnant or nursing
5. History of a different malignancy except for the following circumstances:
* Disease-free for at least five years and deemed by the investigator to be at low risk for recurrence of that malignancy (\<5 %).
* Cervical cancer in situ and basal cell or squamous cell carcinoma of the skin
6. Breast cancer requiring bilateral breast/chest wall radiation therapy.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03422003
Study Brief:
Protocol Section:
NCT03422003