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 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT04522557
Eligibility Criteria:
Inclusion Criteria:
1. Signed the informed consent.
2. Female aged between 18 and 70 years.
3. Pathologically diagnosed operable breast cancer.
4. WHO Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
5. Newly diagnosed breast cancer.
6. The important organ functions meet the following criteria:
* WBC \>=3.0 x 10\^9/L; Neutrophilic granulocytes \>=1.5×10\^9/L; Platelet \>=100 x 10\^9/L; Hb \>=9 g/dL;
* Total bilirubin no more than 1.5 times the normal upper limit (ULN); AST and ALT no more than 1.5 times ULN; AKP no more than 2.5 times ULN;
* Serum creatinine no more than 1.5 times ULN or Clearance rate of creatinine \>= 60ml/min;
* Thyroid stimulating hormone (TSH) \<= ULN (T3, T4 levels need to be detected simultaneously if abnormalities, the patient can be included if T3, T4 levels is normal);
* LVEF basement \>= 50%.
Exclusion Criteria:
1. Evidence of distant metastasis.
2. Any contraindication of nipple-areolar complex (NAC) saving mastectomy (NSM):
* Intraoperative biopsy revealed carcinoma invasion of NAC.
* Paget's disease of breast.
* Tumor distant from NAC less than 1 cm.
3. Any invasive malignancy diagnosed within previous 5 years (other than successfully treated cervical carcinoma in situ, skin basal cell carcinoma or cutaneous squamous cell carcinoma).
4. At least 4 months since prior interferon therapy.
5. At least 3 weeks since prior major surgery requiring general anesthesia.
6. At least 3 weeks since prior radiotherapy or chemotherapy.
7. Hypersensitivity to interferon or other components: urticaria, angioedema, bronchial stenosis, anaphylaxis, or Stevens-Johnson syndrome.
8. Prior organ allograft.
9. Use of an unlicensed or other investigational drug within 4 weeks.
10. Any severe comorbidities, inability to give informed consent or unavailability for follow-up, including but not limited to any of the following:
* Heart failure above NYHA class 2 level; high-risk uncontrollable arrhythmia; unstable angina pectoris; myocardial infarction within 1 intervention.
* Chronic obstructive pulmonary disease requires treatment.
* Chronic liver disease (cirrhosis, chronic active hepatitis, etc.).
* Cerebrovascular accident occurred within 6 months.
* Severe epilepsy or central nervous system diseases.
* Hypertension which cannot be well controlled by antihypertensive drugs.
* Abnormal coagulation, bleeding tendency, or receiving thrombolysis or anticoagulant therapy.
* Chronic renal insufficiency.
* Active infection.
* Psychiatric disability, etc.
11. Pregnant or lactating women.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04522557
Study Brief:
Protocol Section:
NCT04522557