AI-assisted radiotherapy for breast cancer after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.