Type I Interferon Alfa-2a in Postmastectomy Breast Reconstruction

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.