NCT05762900 Ultra-hypofractioNated Adjuvant Radiotherapy ± sImultaneous Integrated Boost for Low-risk Breast Cancer Patients
| NCT ID | NCT05762900 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 65 participants |
| Start Date | 2022-10-25 |
| Primary Completion | 2025-10-25 |
Trial Parameters
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Brief Summary
This is a phase II study to investigate the feasibility of Ultra-hypofractionated radiotherapy with or without simultaneous integrated boost for low risk breast cancer patients who have received breast conservative surgery of mastectomy.
Eligibility Criteria
Inclusion Criteria: 1. Patients diagnosed with invasive or non-invasive breast cancer; 2. The patients have undergone breast-conserving surgery or mastectomy with axillary sentinel nodal biopsy or dissection; 3. Stage ypT0-2N0-1 (if receive neoadjuvant therapy) or stage pT0-2N0-1 (if receive upfront surgery). 4. No distant metastasis; 5. Life expectancy ≥6 months; 6. Organ function is fine (Hemoglobin ≥100g/L, leukocyte ≥2×109/L, neutrophil ≥1×109/L, platelet ≥80×109/L; Creatinine 1.5 mg/dl or less; Alanine aminotransferase/aspartate aminotransferase ≤2.5×UNL.); 7. Patients are willing to cooperate to follow up; 8. Patients should sign the informed consent; 9. Women of childbearing age need effective contraception. Exclusion Criteria: 1. Biopsy proven ipsilateral supraclavicular, infraclavicular or internal mammary nodal involvement. 2. Concurrent or previous neuropathy overlapping with the radiation volume or brachial plexus injury; 3. Patients who had radiotherapy to the ipsilateral
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