AI-assisted radiotherapy for breast cancer after surgery
A Single-center Prospective Phase II Clinical Study With a Non-blind, Single-arm Design Combined With a Parallel External Control Group to Evaluate the Efficacy and Safety of Artificial Intelligence-assisted One-stop Radiotherapy After Breast-conserving Surgery
This study is testing a new AI-assisted radiotherapy method for women with invasive breast cancer after surgery to see if it can make treatment faster and more effective.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 860 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, Radiation |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT06686459 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates an innovative AI-assisted All-in-one (AIO) radiotherapy approach for women with invasive breast cancer who have undergone breast-conserving surgery. The trial aims to determine the feasibility, efficacy, and safety of this streamlined radiotherapy method, which integrates multiple steps to reduce wait times and improve accuracy. By assessing overall survival and recurrence rates, the study seeks to establish standard operating procedures for AIO radiotherapy. Preliminary results indicate significant time savings and high success rates in initial assessments.
Who should consider this trial
Good fit: Ideal candidates include female patients aged 18-70 with newly diagnosed invasive breast cancer who have undergone breast-conserving surgery and meet specific health criteria.
Not a fit: Patients with distant metastasis or those unable to tolerate radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the patient experience by reducing treatment times and improving the accuracy of radiotherapy.
How similar studies have performed: Preliminary results from similar AI-assisted approaches have shown promise, but this specific method is still under exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Female patients aged 18-70 years. 2. ECOG performance status of 0-2. 3. Newly diagnosed invasive breast cancer, underwent breast-conserving surgery plus axillary lymph node dissection, with positive axillary lymph nodes (ypN+) and negative surgical margins. 4\. No distant metastasis. 5. Capable of tolerating radiotherapy. 6. For ER/PR-positive patients, willing to receive anticipated 5 years of endocrine therapy. 7\. For HER2-positive patients, willing to receive anticipated 1 year of anti-HER2 targeted therapy. 8\. For patients requiring neoadjuvant/adjuvant chemotherapy, must have completed chemotherapy. 9\. Left ventricular ejection fraction (LVEF) measured by echocardiography is 50%. 10\. Must undergo adjuvant IMRT (Intensity-Modulated Radiation Therapy). 11. Capable of tolerating lying still on the treatment accelerator bed for 30 minutes to complete All-In-One radiotherapy. 12\. Have follow-up conditions and are willing to adhere to follow-up. 13. Signed an informed consent form. Exclusion Criteria: * 1\. Synchronous bilateral breast cancer; sentinel lymph node biopsy of the axilla was performed without axillary lymph node dissection. 2\. Stage I breast reconstruction surgery or expander implantation surgery on the affected side chest wall. 3\. The purpose of radiotherapy is palliative. 4. Myocardial infarction within the last 3 months or uncorrected unstable arrhythmia or uncorrected unstable angina. 5\. History of chest wall or supraclavicular radiotherapy in the past; past or concurrent second primary malignant tumors (except for non-melanoma skin cancer, papillary/follicular thyroid carcinoma, and carcinoma in situ of the cervix). 6\. All-in-one one-stop radiotherapy has not been completed.
Where this trial is running
Guangzhou
- Sun Yat-sen University Cancer Center — Guangzhou, China (Recruiting)
Study contacts
- Study coordinator: Zhen-Yu He, Professor
- Email: hezhy@sysucc.org.cn
- Phone: 020-87343663
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.