Type I Interferon Alfa-2a in Postmastectomy Breast Reconstruction

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Breast Neoplasms

Clinical Trial Details

NCT number	NCT04522557
Study type	Interventional
Source	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact
Status	Completed
Phase	Phase 1
Start date	August 6, 2020
Completion date	July 14, 2021

View Details

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