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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT06938360
Eligibility Criteria:
Inclusion Criteria:
1. Female patients aged 18-70 years with primary breast cancer;
2. Histopathologically confirmed invasive breast cancer (meeting latest ASCO/CAP guidelines criteria) with:
* TNM stage T1-2;
* Nodal stage N0-1;
3. Ductal carcinoma in situ (DCIS) with maximum tumor diameter \<3 cm;
4. Paget's disease;
5. Neoadjuvant chemotherapy permitted for eligible patients;
6. Unicentric lesion confirmed by breast ultrasound, mammography, and MRI;
7. Nipple-areolar complex resection required for preoperative imaging or pathologically confirmed nipple involvement;
8. Enrolled patients randomized 1:1 to breast-conserving surgery or total mastectomy group;
9. Participants voluntarily signed informed consent forms and completed ethics review procedures.
Exclusion Criteria:
1. Tumor-related characteristics
1. Metastatic or bilateral breast cancer
2. Inflammatory breast cancer
3. Multicentric lesions
2. Comorbidities/treatment history
1. History of other malignancies (except cured cervical carcinoma in situ/basal cell carcinoma/squamous cell carcinoma) or prior anticancer therapy (systemic/local)
2. Major non-breast surgery within 4 weeks before enrollment (excluding diagnostic biopsy/PICC placement) without full recovery
3. Active infections/immune disorders:
HIV/AIDS Viral hepatitis (HBV-DNA≥500 IU/ml; HCV antibody-positive with detectable HCV-RNA) Autoimmune hepatitis HBV/HCV coinfection
4. Allogeneic bone marrow/solid organ transplantation history or planned
5. Cardiovascular diseases:
* Heart failure or LVEF\<50%
* Uncontrolled arrhythmias (resting heart rate\>100 bpm, ventricular tachycardia, Mobitz II/third-degree AV block)
* Angina requiring antianginal drugs
* Clinically significant valvulopathy
* Transmural myocardial infarction on ECG
* Uncontrolled hypertension (SBP\>180 mmHg and/or DBP\>100 mmHg)
3. Reproductive status
Pregnancy/lactation, or reproductive-aged women with:
* Positive baseline pregnancy test
* Refusal of effective contraception
4. Neuropsychiatric disorders Epilepsy, dementia, psychoactive substance abuse, or alcoholism
5. Other investigator-determined exclusionary conditions
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06938360
Study Brief:
Protocol Section:
NCT06938360