None listed
Conditions
Brief summary
This trial is investigating the feasibility of pre-operative high-dose radiation in early breast cancer patients. Who is it for? You may be eligible for this trial if you are a female aged 60 or over, with unifocal breast cancer graded <3 on core biopsies. You must also be oestrogen and progesterone receptor positive, and clinically node negative. Study details Parents recruited to this study will be offered a high radiation dose delivered in a single treatment using an MRI-guided linear accelerator, 6 weeks prior to surgery. They will be followed up for disease response and progression. It is hoped that this study will help investigators examine the feasibility of pre-operative single dose radiotherapy, which may reduce patient inconvenience as well as potentially decreasing side effects of extended radiation treatment.
Interventions
Description of intervention: Magnetic resonance image guided single fraction (21Gy) neo-adjuvant breast radiotherapy administered over a period of 5-10 minutes approximately 6 weeks prior to surgery. Fraction will be delivered to a single lesion by a multidiciplinary team including Radiation Oncologist, radiation therapist, medical physicist and MR radiographers. The fraction delivered will be recorded in the patients medical record and will be reviewed by the clinical team prior to surgery.
Sponsors
Olivia Newton-John Cancer Research Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 60 years or older 2. Unifocal Breast Cancer 3. Tumour visible on pre-treatment imaging 4. Tumour Size on pre-treatment imaging equal to or greater than 2 cm 5. Grade <3 on pre-treatment core biopsy 6. Oestrogen receptor (ER) and Progesterone (PR) positive (>10%) 7. Clinically node negative 8. Willing and able to provide informed consent
Exclusion criteria
1. Previous RT to same breast 2. Suspicious diffuse microcalcifications 3. Invasive lobular carcinoma on core biopsy 4. Lymphovascular invasion on core biopsy 5. Any clinical nodal or metastatic disease 6. HER2 positive 7. Prior non-hormonal therapy 8. Skin or chest wall involvement 9. Collagen vascular disease, e.g. lupus, scleroderma 10. Pregnant or lactating 11. Contraindications to MRI e.g. pacemaker, severe claustrophobia 12. Contraindications to PET or CT 13. Unable or unwilling to provide informed consent.
Outcome results
None listed