Efficacy of Interleukin-2 in Triple Negative Breast Cancer

NCT05821686 | Not Yet Recruiting Phase 1

• 1 other identifier: IL-2.001
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Pathologic response as defined by the residual cancer burden (RCB) index (RCB 0-IV)

  Presence of in-situ disease alone will be considered a pCR

  measured immediately after surgery during routine pathological assessment

Secondary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of intralesional IL-2

  1 year

• Proportion of Patients who Complete 4 cycles of Intralesional IL-2

  1 year

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Intralesional IL-2 therapy x 4 weeks between initial consultation and planned surgery

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

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with biopsy proven TNBC who are not scheduled to receive neoadjuvant chemotherapy.
• Tumors ≤ 2 cm (clinical T1N0)
• Planned upfront surgery (patient preference)
• Medically unable to receive neoadjuvant chemotherapy
• years of age.
• Able to provide consent for the study.
• Able to come to the hospital for the intralesional injections.

You may not qualify if:

• No diagnosis of TNBC.
• Not able to provide consent for the study.
• Not able to come to the hospital for study visits.
• Presence of any contraindication for IL-2 therapy (abnormal thallium stress test, abnormal pulmonary function test, organ allograft and toxicities with a previous dosage).
• Participant has experienced IL-2 related toxicities during an earlier course of therapy (sustained ventricular tachycardia; cardiac arrythmias unresponsive to management; chest pain with ECG changes consistent with angina or myocardial infarction; cardiac tamponade; intubation required \> 72 hours; renal failure requiring dialysis \> 72 hours; coma, or toxic psychosis \> 48 hours; repetitive or difficult to control seizures; bowel ischemia; gastrointestinal bleeding requiring surgery)
• If participant is on cancer treatment drugs and steroids to avoid drug interactions.
• Known pregnancy and breast feeding. There are no known studies to support the use of interleukin in pregnancy and breast-feeding mothers.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Interleukin-2; aldesleukin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: April 20, 2023
• Study Start: January 2, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: February 12, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share