Actively Recruiting
A Phase II Clinical Trial of Artificial Intelligence-assisted One-stop Radiotherapy for Breast Cancer After Breast-conserving Surgery
Led by Sun Yat-sen University · Updated on 2025-07-01
860
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Breast cancer became the most prevalent cancer globally in 2020, and post-surgery radiotherapy is crucial for most patients. Traditional radiotherapy is complex and time-consuming, affecting patient experience. To streamline this, an AI-assisted All-in-one (AIO) radiotherapy approach has been developed, integrating steps like target delineation and planning to reduce wait times and enhance accuracy. Preliminary results are promising, with significant time savings and high pass rates in initial assessments. Further exploration is needed to confirm the accuracy, effectiveness, and safety of AIO radiotherapy. Primary objective: To conduct a prospective phase II clinical trial to determine the feasibility (including efficacy and safety) of AIO radiotherapy, and to provide a basis for establishing standard operating procedures. Secondary objectives: To assess the impact of AIO radiotherapy on overall survival, local regional recurrence, and distant metastasis rates. To investigate the incidence and contributing factors of cardiac damage after AIO radiotherapy.
CONDITIONS
Official Title
A Phase II Clinical Trial of Artificial Intelligence-assisted One-stop Radiotherapy for Breast Cancer After Breast-conserving Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years
- ECOG performance status of 0 to 2
- Newly diagnosed invasive breast cancer
- Breast-conserving surgery plus axillary lymph node dissection with positive axillary lymph nodes and negative surgical margins
- No distant metastasis
- Able to tolerate radiotherapy
- ER/PR-positive patients willing to receive 5 years of endocrine therapy
- HER2-positive patients willing to receive 1 year of anti-HER2 targeted therapy
- Completed neoadjuvant or adjuvant chemotherapy if required
- Left ventricular ejection fraction of 50% measured by echocardiography
- Must undergo adjuvant Intensity-Modulated Radiation Therapy (IMRT)
- Able to lie still on treatment bed for 30 minutes to complete All-In-One radiotherapy
- Willing and able to adhere to follow-up visits
- Signed informed consent form
You will not qualify if you...
- Synchronous bilateral breast cancer or sentinel lymph node biopsy without axillary lymph node dissection
- Stage I breast reconstruction or expander implantation on the affected chest wall
- Radiotherapy intended for palliative purposes
- Myocardial infarction within last 3 months or uncorrected unstable arrhythmia or angina
- Past chest wall or supraclavicular radiotherapy; past or concurrent second primary cancers except certain types
- Did not complete the All-in-One radiotherapy procedure
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, China
Actively Recruiting
Research Team
Z
Zhen-Yu He, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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