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A Phase II Clinical Trial of artificial intelligence-assisted one-stop radiotherapy for breast cancer after breast-conserving surgery

A Phase II Clinical Trial of artificial intelligence-assisted one-stop radiotherapy for breast cancer after breast-conserving surgery

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093133
Enrollment
Unknown
Registered
2024-11-28
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

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

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
incidence rate of adverse effects;

Secondary

MeasureTime frame
overall survical;disease free survival;cumulative internal mammary node recurrence;cumulative locoregional recurrence;distance metastasis;Contralateral non-invasive breast cancer, other secondary malignant tumors;major cardiovascular events;Life quality;

Countries

China

Contacts

Public ContactZhen-Yu He

Sun Yat-sen University Cancer Center

hezhy@sysucc.org.cn+86 135 2772 2806

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026