KORTUC Phase II - Intra-tumoural Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer

To join this study, you must be 18 years or older. You should have breast cancer that is locally advanced or has come back in the local area, and your doctor thinks you need radiotherapy to control it. The cancer lump needs to be big enough to measure (at least 3cm) but not too big (no more than 15cm) and in a place where it's safe to give injections. You should also be generally well enough for radiotherapy and expected to live for at least 12 months.

There are also some reasons why you might not be able to join. For example, if you've already had radiotherapy to the area being studied, or if your cancer is in a spot that's too close to important blood vessels or nerves, you might not be able to take part. This study also can't be for you if you're pregnant or breastfeeding, or if you're allergic to any of the ingredients in the special gel. Most other cancer treatments will need to have stopped at least three weeks before starting, but some specific treatments like Herceptin, Pertuzumab, Denosumab, hormone therapies, and bisphosphonates are allowed.

If you decide to take part, you will receive injections of the special hydrogen peroxide gel directly into your cancer lump. A specialist doctor or trained nurse will give these injections twice a week, throughout your 3-week course of standard radiotherapy. They'll use an ultrasound machine to make sure the injection goes into the right spot, and your skin will be numbed with a local anaesthetic first. Each injection takes about 10-15 minutes. The gel is designed to release the hydrogen peroxide slowly over two days.

Throughout the study, you'll have regular check-ups and scans to see how the treatment is working and to monitor any side effects. You'll be asked to come for appointments that match your radiotherapy schedule. The total time you'd be actively involved in the treatment part of the study is about three weeks, during your radiotherapy. There will also be follow-up appointments to track your progress after treatment has finished. You'll be given all the details about your specific schedule if you're considering joining.