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Efficacy of Interleukin-2 in Triple Negative Breast Cancer

StatusNot Yet Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Notable Lead sponsor: Gregory Knapp to Nova Scotia Health Authority
    • Primary completion date: Apr 2024 to Apr 2028
    • Start date: Jan 2, 2024 to Jan 2, 2026
    • Study completion date: Apr 2025 to Apr 2028
    v4
  2. Notable Primary endpoint revised
    • Interventions: Proleukin 1.3 MG Injection (Drug) to Human Interleukin-2 (IL-2) (Proleukin) (Drug)
    • Secondary endpoints: 3 to 2
    • Study description shortened, about 9 words
    v3
  3. Notable Start date: Apr 2023 to Jan 2, 2024v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05821686
Lead Sponsor Nova Scotia Health Authority
Conditions
(from sponsor)
Triple Negative Breast Cancer
Related terms Triple Negative Breast Neoplasms
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov