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MRI-guided online adaptive partial breast irradiation in early-stage breast cancer patients

MRI-guided online adaptive partial breast irradiation in early-stage breast cancer patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104286
Enrollment
Unknown
Registered
2025-06-13
Start date
2024-09-11
Completion date
Unknown
Last updated
2025-06-16

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

Conditions

Breast Cancer

Interventions

Mg-OA-PBI group:Online adaptive partial breast irradiation guided by magnetic resonance imaging

Sponsors

Peking Union Medical Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Female, aged >= 40 years old; 2. ECOG status grading 0-1 points; 3. Within 8 weeks after unilateral breast conserving surgery; 4. Invasive breast cancer confirmed by pathology shall meet at least 2 of the following conditions: a) tumor size <= 2cm (pT1, see Appendix I) b) histological grading 1-2; c) ER positive (if only b and c are met, the tumor size must be <= 3cm); 5. breast ductal carcinoma in situ confirmed by pathology, which must meet at least one of the following conditions: a) histological grade 1-2; b) Tumor size <= 2cm (if only a is met, tumor size must be <= 3cm); 6. HER-2 positive patients who are expected to receive HER2 targeted therapy for 1 year; 7. ER positive patients who are expected to receive endocrine therapy for 5 years; 8. sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Lymph node positivity; 2. Positive cutting edge; 3. HER-2 positive but not receiving HER-2 targeted therapy; 4. ER positive but not receiving endocrine therapy; 5. Lymphatic vessel infiltration; 6. Invasive lobular carcinoma of the breast; 7. BRCA 1/2 mutation; 8. After neoadjuvant therapy; 9. The breast tumor bed cannot be identified in the localization image; 10. There are pacemakers, claustrophobia, and other conditions in the body that cannot undergo MRI examination; 11. Serious underlying diseases; 12. Severe hematopoietic dysfunction, heart, lung, liver, kidney dysfunction, and immune deficiency; 13. Individuals with neurological or psychiatric disorders that affect cognitive abilities.

Design outcomes

Primary

MeasureTime frame
Early radiation injury;

Secondary

MeasureTime frame
Breast appearance effect;Quality of life;Ipsilateral breast tumor recurrence rate;Disease-Free Survival (DFS);Overall survival;Late radiation injury;

Countries

China

Contacts

Public ContactHou Xiaorong

Peking Union Medical College Hospital

houxr@pumch.cn+86 138 1196 3013

Outcome results

None listed

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