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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
After mastectomy, it is used in the cavity of breast before conducting implantation.
Shicheng Su
Guangzhou, Guangdong, China
Dose-limiting toxicity (DLT)
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.
Time frame: 7 days after surgery
Maximal tolerable dose (MTD)
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.
Time frame: 7 days after surgery
Adverse events (AE)
Time frame: 7 days after surgery
Server adverse events (SAE)
Time frame: 7 days after surgery
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