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 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT06335550
Eligibility Criteria:
Inclusion Criteria:
* Women aged 21-70, with invasive breast cancer, ductal carcinoma in situ (DCIS), Breast Cancer (BRCA) gene or other breast cancer genetic mutation carriers or high risk female patients who are otherwise candidates for conventional NSM/SSM will be eligible for the study. All suitable patients will be offered the option of R-NSM/ R-SSM.
For patients with breast cancer (invasive or DCIS), selection criteria include but not limited to:
1. Early breast cancer
2. Tumor size less than 5 cm
3. No evidence of lymph node metastases
4. No evidence of skin or chest wall invasion.
Exclusion Criteria:
1. Extensive axillary lymph node metastasis (Stage 3B or later)
2. Heavy smokers (\>20 cigarettes a day)
3. High risk patient with severe and poorly controlled co-morbid conditions (include but not limited to diabetes, heart disease, renal failure or liver dysfunction)
4. Poor performance status or high risk for anaesthesia (ASA 3 and above)
5. Inflammatory or Locally Advanced Breast Cancer (with or without chest wall or skin invasion)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT06335550
Study Brief:
Protocol Section:
NCT06335550