Clinical trial · Interventional
Efficacy of Interleukin-2 in Triple Negative Breast Cancer
Efficacy of Intralesional IL-2 for Resectable Triple Negative Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Human Interleukin-2 (IL-2) (Proleukin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention Arm
- description
- Intralesional IL-2 therapy x 4 weeks between initial consultation and planned surgery
- interventionNames
- Drug: Human Interleukin-2 (IL-2) (Proleukin)
Primary outcomes (1)
- measure
- Pathologic response as defined by the residual cancer burden (RCB) index (RCB 0-IV)
- timeFrame
- measured immediately after surgery during routine pathological assessment
- description
- Presence of in-situ disease alone will be considered a pCR
Secondary outcomes (2)
- measure
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of intralesional IL-2
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women with biopsy proven TNBC who are not scheduled to receive neoadjuvant chemotherapy. 2. Tumors ≤ 2 cm (clinical T1N0) 3. Planned upfront surgery (patient preference) 4. Medically unable to receive neoadjuvant chemotherapy 5. 18 - 80 years of age. 6. Able to provide consent for the study. 7. Able to come to the hospital for the intralesional injections. Exclusion Criteria: 1. No diagnosis of TNBC. 2. Not able to provide consent for the study. 3. Not able to come to the hospital for study visits. 4. Presence of any contraindication for IL-2 therapy (abnormal thallium stress test, abnormal pulmonary function test, organ allograft and toxicities with a previous dosage). 5. 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) 6. If participant is on cancer treatment drugs and steroids to avoid drug interactions. 7. Known pregnancy and breast feeding. There are no known studies to support the use of interleukin in pregnancy and breast-feeding mothers.
References
Publications (0)
Data not yet available