Status:
COMPLETED
Type I Interferon Alfa-2a in Postmastectomy Breast Reconstruction
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18-70 years
Phase:
PHASE1
Brief Summary
RATIONALE: Implant-based reconstruction have become the most popular choices of reconstruction for women undergoing breast mastectomy. Postoperative complications like infection and tumor recurrence l...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2021
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04522557
Start Date
August 6 2020
End Date
July 14 2021
Last Update
February 9 2022
Active Locations (1)
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1
Shicheng Su
Guangzhou, Guangdong, China, 510120