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Efficacy of Interleukin-2 in Triple Negative Breast Cancer

NCT05821686 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-02-12

No results posted yet for this study

Summary

This study is a single arm, phase II pilot design. The study will evaluate the safety and efficacy of intralesional immunotherapy (e.g. IL-2) in early stage TNBC. The overall objective of the research study is to advance our knowledge of novel immunotherapies and routes of administration for the treatment of TNBC

HYPOTHESES: Neoadjuvant treatment of TNBC with intralesional IL-2 is safe and well tolerated and can produce a pathological response.

Aim 1: Examine the safety and possible efficacy of a novel neoadjuvant intralesional intervention (IL-2) for patients with early-stage TNBC.

Conditions

Interventions

DRUG

Human Interleukin-2 (IL-2) (Proleukin)

All the recruited participants will receive 4 intralesional injections of Interleukin-2 with a dose of 500,000 international units (IU) per mm width of tumor to max dose of 10 million IU.

Sponsors & Collaborators

  • Nova Scotia Health Authority

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-02
Primary Completion
2028-04-30
Completion
2028-04-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05821686 on ClinicalTrials.gov