Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Radiotherapy (RT) Plus KORTUC: 49.5Gy in 18 daily fractions of 2.75Gy plus 5-6 intratumoural KORTUC injections twice-weekly
OR 36Gy in 6 twice-weekly fractions of 6Gy plus 4-5 intratumo
Sponsors
The Institute of Cancer Research
IQVIA RDS INDIA PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: Patient age 18 years and over. Primary locally advanced breast cancer, or locally recurrent breast cancer with/without metastases Radical/high dose palliative RT required for lifetime control of local morbidities. Patient physically and mentally fit for radical/high dose palliative RT. Target tumour accessible for intra-tumoural injection. Patient suitable/compliant with MRI protocol At least one tumour diameter =30mm and =150mm measurable by ultrasound, MRI, CT or PET-CT Patients with predicted life expectancy of 12 months or more. Negative pregnancy test before start of RT in women of child bearing potential and an ability/ willingness to protect against pregnancy from consent and for 3 months post-RT. Documented informed consent obtained.
Exclusion criteria
Exclusion criteria: Prior RT to the target area. Maximum diameter of target tumour 150mm measurable by ultrasound, MRI, CT or PET-CT. 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). Pregnancy or nursing. Hypersensitivity to any of the KORTUC ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To test efficacy Timepoint: Complete tumour response based on best response assessed by contrast enhanced MRI, according to criteria outlined in protocol, performed up to and including 12 months post-RT. | — |
Secondary
| Measure | Time frame |
|---|---|
| To further characterise efficacy & safetyTimepoint: Overall survival at 6,12&24 months Loco-regional recurrence,local progression-free survival & distant recurrence at 6, 12 & 24 months Proportion of patients with either complete response on MRI up to & including 12 months or pathological complete response following tumour resection before 12 months. Proportion of patients with partial response & stable disease Planned/unplanned tumour excision & pathological response Adverse events Compliance with KORTUC administration | — |
Countries
India, United Kingdom
Contacts
Public ContactDr Sanjoy Chatterjee
Tata Medical Center
Outcome results
None listed