Type I Interferon Alfa-2a in Postmastectomy Breast Reconstruction

Inclusion criteria

• Signed the informed consent.
• Female aged between 18 and 70 years.
• Pathologically diagnosed operable breast cancer.
• WHO Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Newly diagnosed breast cancer.
• 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

• Evidence of distant metastasis.
• 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.
• 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).
• At least 4 months since prior interferon therapy.
• At least 3 weeks since prior major surgery requiring general anesthesia.
• At least 3 weeks since prior radiotherapy or chemotherapy.
• Hypersensitivity to interferon or other components: urticaria, angioedema, bronchial stenosis, anaphylaxis, or Stevens-Johnson syndrome.
• Prior organ allograft.
• Use of an unlicensed or other investigational drug within 4 weeks.
• 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.
• Pregnant or lactating women.