A Phase II Clinical Trial of Artificial Intelligence-assisted One-stop Radiotherapy for Breast Cancer After Breast-conserving Surgery (BC-AIO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Invasive
• Intervention / Treatment: Radiation: ALL-in-one radiotherapy; Radiation: IMRT

• Study Type: Interventional
• Enrollment (Estimated): 860
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhen-Yu He, Professor; Phone Number: 020-87343663; Email: hezhy@sysucc.org.cn

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • Sun Yat-sen University Cancer Center
    • Contact: Rui-Hua Xu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALL-in-one group; ALL-in-one radiotherapy (breast + supraclavicular + internal mammary lymph node drainage area)	Radiation: ALL-in-one radiotherapy; ALL-in-one radiotherapy (breast + supraclavicular + internal mammary lymph node drainage area)
Placebo Comparator: IMRT group; IMRT (breast + supraclavicular + internal mammary lymph node drainage area)	Radiation: IMRT; IMRT (breast + supraclavicular + internal mammary lymph node drainage area)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence rate of adverse effects	12 months after the end of radiotherapy

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survical	measured from baseline through study completion, an average of 1 year
disease free survival	measured from baseline through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Actual): November 13, 2024

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 29, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SL-B2024-438-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No