Actively Recruiting
A Phase II Study of Artificial Intelligence-assisted One-stop Radiotherapy Versus IMRT After Breast-conserving Surgery for Breast Cancer
Led by Sun Yat-sen University · Updated on 2025-07-01
860
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Breast cancer became the most common cancer worldwide in 2020, and radiotherapy after breast-conserving surgery is important for many patients. Researchers are studying an AI-assisted All-in-one (AIO) radiotherapy method that combines several steps such as target area outlining and treatment planning to make the process faster and more accurate. This phase II clinical trial aims to evaluate whether this AIO approach is feasible, effective, and safe, while providing a foundation for standard procedures. The trial compares two radiotherapy methods given to female breast cancer patients: the experimental AIO radiotherapy covering the breast and regional lymph nodes, and the conventional intensity-modulated radiation therapy (IMRT) covering the same areas. Participants will receive radiotherapy after surgery and may also undergo endocrine or targeted therapies if needed. The study is non-randomized and includes a parallel external control group to assess outcomes over about one year. Participants will be monitored for adverse effects for 12 months after radiotherapy ends, and researchers will measure overall survival and disease-free survival during the study. Patients need to be able to tolerate lying still for about 30 minutes during treatment and agree to follow-up visits. The study is sponsored by Sun Yat-sen University and aims to better understand the safety and impact of AI-assisted radiotherapy for breast cancer treatment.
CONDITIONS
Brief 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 0 to 2
- Newly diagnosed invasive breast cancer with positive axillary lymph nodes after breast-conserving surgery plus axillary lymph node dissection
- No distant metastasis
- Capable of tolerating radiotherapy
- For ER/PR-positive patients, willing to receive 5 years of endocrine therapy
- For HER2-positive patients, willing to receive 1 year of anti-HER2 targeted therapy
- Completed any required neoadjuvant or adjuvant chemotherapy
- Left ventricular ejection fraction (LVEF) of at least 50% by echocardiography
- Must undergo adjuvant IMRT
- Able to lie still on treatment bed for 30 minutes to complete All-in-One radiotherapy
- Willing to adhere to follow-up
- 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 surgery or expander implantation on affected chest wall
- Radiotherapy intended for palliative purposes
- Myocardial infarction within last 3 months or uncorrected unstable arrhythmia or angina
- History of chest wall or supraclavicular radiotherapy; past or concurrent second primary malignancies except certain skin, thyroid, or cervical cancers
- Incomplete All-in-one one-stop radiotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 30 minutes per radiotherapy session
Participants receive either ALL-in-one radiotherapy or IMRT after breast-conserving surgery for breast cancer.
1 radiotherapy session (in-person)
Duration - 12 months after the end of radiotherapy
Participants are monitored for adverse effects and survival outcomes after completing radiotherapy.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, China
Actively Recruiting
Research Team
Z
Zhen-Yu He, Professor
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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