All early breast cancer patients are offered adjuvant breast radiation therapy (RT) after breast conserving surgery for an early breast cancer. Breast cancer is heterogeneous, and selected patients have a very low gain from RT, whilst they still have risk of acute and late side effects from RT. This trial will try identify selection criteria for low risk breast cancer patients who can safely omit adjuvant RT without unacceptable high risk of local failure.
Who can participate
Age range
60 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 patient \>=60 years
Primary tumour characteristics by conventional histopathology
* unilateral and unifocal non-lobular histology grade 1-2
* maximum microscopic size \<=20mm
* node negative determined by sentinel node or axillary lymph node dissection
* estrogen receptor \>=10% positive
* HER2 negative (by IHC and/or in situ hybridization)
* resection margin \>=2 mm for invasive carcinoma and any ductal carcinoma in situ associated with the cancer
Surgical type is breast conservation
Performance status ECOG 0-2
No evidence of distant metastasis
Exclusion Criteria:
* multifocal or multicentric invasive carcinoma or ductal carcinoma in situ
* evidence of clinical or pathological T4 breast cancer
* grade 3 malignancy
* previous breast cancer or DCIS irrespective of disease-free interval
* previous radiation therapy to the breast or thorax,
* previous neoplasm within 5 years except carcinoma in situ of the cervix, endometrium or coli, melanoma in situ.
* comorbidity precluding the patient from radiation therapy (e.g. cardiovascular or pulmonary disease, scleroderma, systemic lupus erythematosus).
* mental/psychiatric disorder which precludes the patient from understanding the randomization and the follow up.
* documented hereditary breast cancer or with high genetic risk of breast cancer
* life expectancy \<10 years
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.