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NCT05821686Not yet recruitingPhase 1/2

Efficacy of Interleukin-2 in Triple Negative Breast Cancer

Efficacy of Intralesional IL-2 for Resectable Triple Negative Breast Cancer

Source: ClinicalTrials.gov · Last updated 12 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
10 (estimated)
First submitted
18 Nov 2022
Start date
2 Jan 2026
Primary completion date
Apr 2028
Lead sponsor
Nova Scotia Health Authority
NCT number
NCT05821686

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 10
  • From 2 Jan 2026 to the primary completion date, Apr 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Presence of any contraindication for IL-2 therapy (abnormal thallium stress test, abnormal pulmonary function test, organ allograft and toxicities with a previous dosage).

Other illness

  • 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.

Other

  • No diagnosis of TNBC.
  • Not able to provide consent for the study.
  • Not able to come to the hospital for study visits.
  • Known pregnancy and breast feeding. There are no known studies to support the use of interleukin in pregnancy and breast-feeding mothers.

Who the study is looking for

  • 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
  • 18 - 80 years of age.
  • Able to provide consent for the study.
  • Able to come to the hospital for the intralesional injections.

Age in the registry: 18 years to 80 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.