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NCT Number: NCT06686459

A Phase II Clinical Trial of Artificial Intelligence-assisted One-stop Radiotherapy for Breast Cancer 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.

Recruiting

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Key information

Conditions

Breast Cancer Invasive

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, China

Location status: Recruiting

Location contact

Rui-Hua Xu

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • No distant metastasis. 5. Capable of tolerating radiotherapy. 6. For ER/PR-positive patients, willing to receive anticipated 5 years of endocrine therapy.
  • For HER2-positive patients, willing to receive anticipated 1 year of anti-HER2 targeted therapy.
  • For patients requiring neoadjuvant/adjuvant chemotherapy, must have completed chemotherapy.
  • Left ventricular ejection fraction (LVEF) measured by echocardiography is 50%.
  • 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.
  • 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.
  • Stage I breast reconstruction surgery or expander implantation surgery on the affected side chest wall.
  • The purpose of radiotherapy is palliative. 4. Myocardial infarction within the last 3 months or uncorrected unstable arrhythmia or uncorrected unstable angina.
  • 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).
  • All-in-one one-stop radiotherapy has not been completed.

Treatment and study plan

ALL-in-one radiotherapy

Radiation

ALL-in-one radiotherapy (breast + supraclavicular + internal mammary lymph node drainage area)

IMRT

Radiation

IMRT (breast + supraclavicular + internal mammary lymph node drainage area)

Primary outcomes

  1. incidence rate of adverse effects

    Time frame: 12 months after the end of radiotherapy

Secondary outcomes

  1. overall survical

    Time frame: measured from baseline through study completion, an average of 1 year

  2. disease free survival

    Time frame: measured from baseline through study completion, an average of 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Zhen-Yu He, Professor

CONTACT

[email protected]

020-87343663

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Acronym: BC-AIO

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 13, 2024
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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