Efficacy of Interleukin-2 in Triple Negative Breast Cancer

Launched by NOVA SCOTIA HEALTH AUTHORITY · Apr 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for women with early-stage triple-negative breast cancer (TNBC), which is a type of breast cancer that doesn’t respond to certain common treatments. The researchers want to see if using a therapy called interleukin-2 (IL-2) directly into the tumor is safe and if it can help shrink the cancer before surgery. This approach is known as immunotherapy, which works by helping the body’s immune system fight the cancer. The trial is not yet recruiting participants, but it is looking for women aged 18 to 80 who have been diagnosed with TNBC and have tumors that are 2 cm or smaller, and who are not planning to receive chemotherapy before surgery.

If you or someone you know is considering participating in this trial, it's important to know that participants will receive IL-2 injections at the hospital and will be monitored closely for any side effects. However, certain health conditions or treatments may prevent someone from joining, such as previous serious reactions to IL-2 or being on other cancer treatments. The goal of this study is to learn more about how effective and safe this new treatment approach can be for women with this challenging type of breast cancer.

Gender

FEMALE

Eligibility criteria

• 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.