None listed
Conditions
Brief summary
The study is evaluating the feasibility of hyper-accelerated partial breast irradiation therapy in women with breast cancer. Who is it for? You may be eligible to join this study if you are a woman aged 40 years or above who has been diagnosed with invasive non-lobular breast carcinoma and have had breast conserving surgery. Trial details: All participants in this study will undergo a procedure called hyper-accelerated partial breast irradiation. This involves catheters implantation under general anaesthetic followed by three treatment doses of brachytherapy radiation. All participants will be followed up for a maximum of 10 years to assess for recurrences and quality of life, which will involve performing annual mammogram scan and completing questionnaires (6 weeks, 6 months and annually for 5 years). A peripheral blood sample and the resected tumour sample will also be assessed at the time of commencing therapy (and then 6 weeks,1 year, 5 year and 10 year) to identify potential biomarkers of local disease recurrence. It is hoped that this study may show that hyper-accelerated partial breast irradiation therapy is feasible, safe, and efficacious for the treatment of locally advanced breast cancer. It may also help to identify biomarkers to allow for accurate selection of patients who are suitable for this treatment in future.
Interventions
Brachytherapy involves catheter implantation and delivery of internal radiotherapy to a portion of the affected breast. Radiation oncologist is the doctor responsible for this intervention procedure.
Specifically, patient will undergo catheter insertion under general anaesthetic. With ultrasound guidance, approximately 15 to 30 catheters will be inserted into the high risk area of the affected breast.
After discharge from surgery recovery, patient will have a chest CT scan to generate an approp
Brachytherapy involves catheter implantation and delivery of internal radiotherapy to a portion of the affected breast. Radiation oncologist is the doctor responsible for this intervention procedure. Specifically, patient will undergo catheter insertion under general anaesthetic. With ultrasound guidance, approximately 15 to 30 catheters will be inserted into the high risk area of the affected breast. After discharge from surgery recovery, patient will have a chest CT scan to generate an appropriate treatment plan. Subsequently delivery of the radiation will start by connecting the catheters to the brachytherapy machine via transfer tubes. Patient will be by herself inside the treatment room and will be carefully monitored with closed circuit television and microphones. Treatment will then take approximately 5 to 10 minutes. Overall, the prescribed radiation dose is 22.5 Gy in 3 fractions, which means there will be three treatment doses to be delivered over two days. Patient do not need to be admitted to hospital during this time unless the radiation oncologist feels that it is medically necessary. After completing the three treatment doses, the catheters will be cut and removed. Patient has completed the brachytherapy.
Sponsors
South Eastern Sydney Local Health District
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a) Women, aged 40 years and above. b) Performance status 0-2. c) Unicentric, invasive breast carcinoma of non-lobular histology with a maximal microscopic dimension of less than or equal to 3cm. d) Treated with breast conserving surgery. e) Bilateral breast imaging with mammograms and ultrasound scans no longer than 3 months prior to surgery. f) Negative radial resection margins either from primary excision or re-excision, defined as: • no tumour at inked margin for the invasive tumour component and • greater than or equal to 2mm from the inked margin for the associated intraductal tumour component. Patients with positive resection margins at either superficial or deep margins are still eligible if the surgeon confirms that all intervening breast tissue has been removed from the subcutaneous tissue or the pectoralis fascia. g) No extensive intraductal component (EIC), defined as intraductal component constituting greater than or equal to 25% of the primary tumour with intraductal foci and/or adjacent to the primary tumour. h) No lymphovascular invasion (LVI), defined as carcinoma cells present within a definite, endothelial-lined space (lymphatic and/or blood vessel), in peri-tumoural tissues. Possible or suspicious LVI, defined as carcinoma cells present within a space with the appearance of a vessel but without a recognisable endothelial lining, is allowed. i) No cutaneous involvement, including Paget’s disease of the nipple, oedema (peau d’orange), satellite skin nodules, skin ulceration or inflammatory carcinoma. j) Oestrogen receptor positive. k) Human epidermal growth factor receptor 2 (HER-2) negative, as determined by immunohistochemistry (IHC) staining and/or dual in-situ hybridisation (D-ISH) techniques. l) Negative axillary lymph node involvement on histopathology, classified as either: • no tumour cells OR • isolated tumour cells (ITC), defined by a single or cluster of tumour cells, no larger than 0.2mm in maximal dimension. m) Clearly defined surgical excision cavity on both assessment ultrasound and computed tomography (CT) scans. n) Ratio of excision cavity volume to the whole breast volume less than or equal to 25%, defined on the assessment CT scan. o) Willingness to give written informed consent. p) Willingness to participate and comply with the study protocol.
Exclusion criteria
a) Multifocal or multicentric breast cancer. b) Inability to determine microscopic resection margins of the primary breast cancer. c) Locally recurrent breast cancer. d) History of prior malignancies, except for non-melanomatous skin cancer, carcinoma in-situ of the uterine cervix or contralateral invasive non-lobular breast cancer. e) Pre-existing connective tissue disorder, such as scleroderma, systemic lupus erythematosis and dermatomyositis. f) Prior radiation treatment to the ipsilateral breast or thoracic region. g) Women who are lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study. h) Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study. i) Patients who are unwilling to have their blood or tissue samples collected and stored for further genetic testing.
Outcome results
None listed