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)
Parallel
Hydrogen Peroxide
DrugHydrogen Peroxide
Complete tumour response based on best response assessed by contrast enhanced MRI according to criteria outlined in Section 3.2.1 of the trial protocol, performed up to and including 12 months post radiotherapy
Overall survival at 6, 12 and 24 months
Loco-regional progression-free survival and distant recurrence at 6, 12 and 24 months
Proportion of patients with either complete response on MRI up to and including 12 months or pathological complete response following tumour resection before 12 months
Proportion of patients with partial response and stable disease
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Institute of Cancer Research, United Kingdom
Lead sponsor
Kortuc, Inc.
Collaborator
