Type I Interferon Alfa-2a in Postmastectomy Breast Reconstruction

NCT04522557 | Completed Phase 1 DMC

• 1 other identifier: 2020-KY-051
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

Breast reconstruction; Implants; Interferon (IFN)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  7 days after surgery

Secondary Outcomes (2)

• Adverse events (AE)

  7 days after surgery

• Server adverse events (SAE)

  7 days after surgery

Study Arms (1)

Experimental: Participants with breast cancer enrolled in grou

EXPERIMENTAL

Drug: IFNα-2a

Interventions

IFNα-2a DRUG

After mastectomy, it is used in the cavity of breast before conducting implantation.

Experimental: Participants with breast cancer enrolled in grou

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Shicheng Su

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shicheng Su, M.D.,Ph.D.

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Shuhua Breast Cancer Research Center of Sun Yat- sen Memorial Hospital

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 21, 2020
• Study Start: August 6, 2020
• Primary Completion: July 14, 2021
• Study Completion: July 14, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-02

Locations

CN (1)