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Type I Interferon Alfa-2a in Postmastectomy Breast Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04522557
Recruitment Status : Completed
First Posted : August 21, 2020
Last Update Posted : February 9, 2022
Sponsor:
Information provided by (Responsible Party):
Shicheng Su, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Description
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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 limit its application. Interferons (IFNs) are pleiotropic cytokines that involve in immunoregulatory, anticancer and restricting infection. Especially, type I IFN signaling is reported favourable for the success of conventional chemotherapeutics, radiotherapy and immunotherapy. In addition, type I IFN can regulate the activity of almost all immune cell types (including T cells, macrophages and innate lymphocytes), creating a well-established immune environment to defense infectious and relapsing disease. Implants are rapidly coated with extracellular matrix proteins and immune protein components for the formation of a typical capsule. At the specific time point before implantation, the locally utilized of IFN in intracavity breast is assumed to modify cellular immune responses thus contributing to decreasing infection and tumor recurrence.

PURPOSE: This non-randomized phase I trial aims to explore dose range of IFNα-2a. Adverse events are observed to assess drug safety and human tolerance index.


Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: IFNα-2a Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Type I Interferon Alfa-2a in Postmastectomy Breast Reconstruction
Actual Study Start Date : August 6, 2020
Actual Primary Completion Date : July 14, 2021
Actual Study Completion Date : July 14, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental: Participants with breast cancer enrolled in grou Drug: IFNα-2a
After mastectomy, it is used in the cavity of breast before conducting implantation.


Outcome Measures
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Primary Outcome Measures :
  1. Dose-limiting toxicity (DLT) [ Time Frame: 7 days after surgery ]
    Dose-limiting toxicity (DLT), defined as certain grade II toxicity such as nephrotoxicity and cardiotoxicity, grade III non-hematologic toxicity and grade IV hematologic toxicity.

  2. Maximal tolerable dose (MTD) [ Time Frame: 7 days after surgery ]
    Maximal tolerable dose (MTD), defined as a dose level where 2 or more subjects among 6 subjects suffering DLT. If the experiment reached the set maximum dose without any DLT occurring, the maximum dose was defined as MTD.


Secondary Outcome Measures :
  1. Adverse events (AE) [ Time Frame: 7 days after surgery ]
  2. Server adverse events (SAE) [ Time Frame: 7 days after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04522557


Locations
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China, Guangdong
Shicheng Su
Guangzhou, Guangdong, China, 510120
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
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Principal Investigator: Shicheng Su, M.D.,Ph.D. Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
More Information
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Responsible Party: Shicheng Su, Director of Shuhua Breast Cancer Research Center of Sun Yat- sen Memorial Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT04522557    
Other Study ID Numbers: 2020-KY-051
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: February 9, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shicheng Su, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:
Breast reconstruction
Implants
Interferon (IFN)
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Interferon alpha-2
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents