Efficacy of Interleukin-2 in Triple Negative Breast Cancer

Sponsor
Nova Scotia Health Authority
Study ID
NCT05821686
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Human Interleukin-2 (IL-2) (Proleukin) — DRUG
    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.

Study Details

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.

Key Dates

First listed
Apr 20, 2023
Start date
Jan 2, 2026
Status verified
Aug 2024
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Arm
    Intralesional IL-2 therapy x 4 weeks between initial consultation and planned surgery

Primary Outcome Measure

Pathologic response as defined by the residual cancer burden (RCB) index (RCB 0-IV) [ Time Frame: measured immediately after surgery during routine pathological assessment ]

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