Risk-Stratified Hypofractionated Radiotherapy After Breast-Conserving Surgery for Early Breast Ca… (NCT07657442) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Risk-Stratified Hypofractionated Radiotherapy After Breast-Conserving Surgery for Early Breast Cancer
China649 participantsStarted 2026-06-15
Plain-language summary
This prospective study is designed to evaluate the feasibility, efficacy, and safety of risk-stratified hypofractionated radiotherapy after breast-conserving surgery in patients with early breast cancer.
Who can participate
Age range
18 Years – 75 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:
* ECOG performance status score of 0 to 2.
* Pathologically confirmed breast cancer, including invasive carcinoma or ductal carcinoma in situ.
* Clinical stage cT0-2N0M0.
* Underwent breast-conserving surgery.
* Negative surgical margins greater than 2 mm.
Exclusion Criteria:
* Regional lymph node metastasis.
* Distant metastasis.
* Bilateral breast cancer.
* Prior thoracic radiotherapy.
* Life expectancy of less than 5 years.
* Lactating or pregnant women.
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 is testing a 'risk-stratified hypofractionated' approach to radiotherapy after lumpectomy — can you explain what it means to tailor the radiation schedule to my risk level, and whether my specific cancer profile would fall into a higher or lower risk group under this kind of approach?
2Since the trial is listed as 'not yet recruiting,' how soon do you expect it to open, and is it worth waiting to see if I might be eligible, or would starting standard radiotherapy now be the safer path for my situation?
3The main thing this trial is measuring is local recurrence rate — can you help me understand what local recurrence means in my case, and how the recurrence rates seen with hypofractionated schedules in past research compare to standard radiotherapy for someone like me?
4This trial has no listed phase, which seems different from typical drug trials — can you explain what that means for what's already known about the safety and effectiveness of this radiation approach before deciding whether it's worth considering?
5How would the radiotherapy schedule in this trial actually differ from what I'd receive under standard care after breast-conserving surgery, and would it affect the number of hospital visits or the overall time commitment I'd be looking at?
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 rate
Timeframe: Five years
Trial details
NCT IDNCT07657442
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences