This is a study aimed at testing a commonly available and inexpensive chemical (hydrogen peroxide) for efficacy in sensitising large cancerous lumps in the breast to a standard course of radiotherapy in patients with locally advanced or recurrent breast cancer. Laboratory research and initial clinical trials in Japan suggest that 4 to 6 injections of a radiation sensitiser ('KORTUC') based on very dilute (0.5%) hydrogen peroxide injected into cancers under local anaesthetic twice a week during radiotherapy greatly increases the effectiveness of standard doses of radiotherapy alone. The side effects are limited to mild/moderate discomfort at the injection site for up to 24 hours reported by Japanese breast cancer patients in whom this treatment has been tested. Complete tumour shrinkage in 70/71 (98%) primary breast cancers up to 5 cm diameter have been reported by Japanese collaborators.
Patient age 18 years and over
Primary locally advanced breast cancer, or locally recurrent breast cancer with/without metastases (metastases, if present, should be stable or oligometastatic)
Radical/high dose palliative radiotherapy required for lifetime control of local morbidities
Patient physically and mentally fit for radical/high dose palliative radiotherapy
Prior radiotherapy to the target area
Maximum diameter of target tumour <30 mm or >150mm measurable by ultrasound or MR
Anatomical location and/or extent of disease difficult to access for safe intra-tumoural drug injections, for example by virtue of contiguous major blood vessels and/or brachial plexus
Concomitant chemotherapy or biological therapy except Herceptin, Pertuzumab and Denosumab (all endocrine therapies and bisphosphonates are allowed concomitantly; other cytotoxics and biological therapies apart from those mentioned above should be stopped 3 weeks prior to RT)
Institute of Cancer Research, United Kingdom
Lead sponsor
Kortuc, Inc.
Collaborator