Plain-English translation of NCT07652242 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.
This is one of the first times this treatment has been tested in people.
This is an early-stage trial testing a new vaccine called ITI-5000 designed to help prevent triple-negative breast cancer from coming back after you've completed surgery, chemotherapy, and/or radiation. The vaccine works by training your immune system to recognize and attack cancer cells. In the first part of the study, researchers will test the vaccine alone at two different doses to see which is safest and how well your body responds. In the second part, participants will receive the vaccine combined with , an existing immunotherapy drug that's already approved for cancer treatment.
Triple-negative breast cancer is harder to treat than other types of breast cancer because standard hormone therapies don't work against it, and patients face a higher risk of recurrence even after completing standard treatment. This trial aims to see whether training the immune system with this new vaccine can help prevent the cancer from returning.
You likely qualify if…
You likely don't qualify if…
If you're in the first part of the study, you'll receive injections of the vaccine into your arm muscle once a month for three months, with close monitoring for side effects. In the second part, you'll receive the same vaccine injections combined with intravenous infusions of every three or six weeks (depending on the schedule your doctor chooses). Throughout the study, you'll have regular visits for blood tests, physical exams, and imaging scans to monitor your health and how your immune system is responding to the treatment. The entire study commitment will span several months.
AI-generated summary from trial data · Jul 3, 2026 · Not medical advice
United States