The primary objective of this study is to determine in women with node negative BC ≤3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.
Who can participate
Age range
50 Years – 120 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female with a new histological diagnosis of invasive carcinoma of the breast with no evidence of metastatic disease (see AJCC TNM Cancer Staging, Appendix II).
. Treated by BCS with microscopically clear resection margins \>= 1mm for invasive and non-invasive disease or no residual disease on re-excision.
. Negative axillary node involvement as determined by either sentinel lymph node biopsy or axillary node dissection or clinical assessment with a negative axillary ultrasound and/or biopsy, for women with unifocal tumours \<= 2cm, histologic grade 1 or 2, ER or PR+ and HER2-ve that are being planned for endocrine therapy
Exclusion criteria
. Age less than 50 years.
. Known to be BRCA 1 and/or BRCA 2 positive.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses only five radiation sessions instead of the more typical longer course — can you help me understand how that compressed schedule might affect my safety and the cosmetic appearance of my breast over time, based on what's already known?
2Since the trial is measuring local recurrence and cosmetic outcomes at three years, what would happen to my monitoring and care if I enroll — and what does 'local recurrence' mean in practical terms for my situation?
3How does the five-fraction partial breast irradiation approach in this trial compare to the standard whole-breast radiation I might otherwise receive, and is standard treatment a better first option for someone with my specific diagnosis?
4Because this is a Phase 3 trial, what does that mean for how much is already known about the safety and effectiveness of this approach, and are there any side effects I should be especially aware of before deciding?
5The trial is randomized, meaning I might be assigned to different treatment groups — can you explain what the different arms of this study are and how that might affect my day-to-day schedule and treatment experience?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Local Recurrence
Timeframe: Annually for 5 years post-randomization
. Tumour size \>3cm in greatest diameter on pathological examination.
. Evidence of extensive intraductal component (EIC) (defined as an invasive tumour with a ductal carcinoma in situ (DCIS) component comprising at least 25% and extending beyond the invasive component to surrounding normal breast tissue) with the following exception: smaller tumours with EIC where the combined size (of the invasive and DCIS components) are \<= 3cm remain eligible
. Evidence of a DCIS component \> 3cm
. Lobular carcinoma only.
. More than one primary tumour in different quadrants of the same breast (patients with multifocal breast cancer are eligible).
. Synchronous or previous contralateral breast cancer (patients with contralateral DCIS or LCIS are eligible).