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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT05833659
Eligibility Criteria:
Inclusion Criteria:
1. Female patients with preoperative pathologically confirmed early-stage invasive breast cancer (stage I or stage II) by core needle biopsy.
2. Breast-conserving surgery is not possible due to the presence of contraindications to breast-conserving surgery, or the patient actively requests total mastectomy.
3. Patients having willingness for breast reconstruction.
4. Age between 18 to 70 years.
5. Maximum diameter of the cancer lesion ≤ 3 cm.
6. Physical examination and breast magnetic resonance imaging (MRI) confirmed that the tumor did not invade the skin, subcutaneous tissue, or chest wall.
7. The distance between the lesion and the nipple is ≥2 cm, and it is confirmed by physical examination and MRI that the nipple-areola complex is not invaded.
8. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale of 0 to 2.
Exclusion Criteria:
1. patients having serious medical diseases, including unstable angina pectoris, myocardial infarction, and cerebrovascular accident within 6 months.
2. Having history of malignant tumor (s) within 5 years.
3. Patients under immunosuppressive therapy for organ transplantation.
4. Having continuous systemic steroid hormone therapy.
5. Pregnant or lactating women.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05833659
Study Brief:
Protocol Section:
NCT05833659