Clinical trial · Interventional
Ultra-hypofractioNated Adjuvant Radiotherapy ± sImultaneous Integrated Boost for Low-risk Breast Cancer Patients
Ultra-hypofractioNated Radiotherapy ± sImultaneous Integrated Boost for Low-risk(risQue) Breast Cancer Patients After Breast Conservative sUrgery or mastEctomy (UNIQUE)
NCT05762900CI-TRIAL-00064610UNIQUErecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultra-fractionated radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ultra-hypofractionated arm
- description
- The patients will be treated by Ultra-hypofractionated irradiation.
- interventionNames
- Radiation: Ultra-fractionated radiation therapy
Primary outcomes (1)
- measure
- The rate of patients who develop radiation-associated acute toxicity (≥ 2 degree)
- timeFrame
- until 12 weeks from the completion of postoperative radiotherapy
- description
- The investigators will record the incidence of ≥ 2 degree radiation-associated acute toxicity, such as breast or chest wall oedema, acute dermatitis, breast pain,itch of breast skin; ≥ 3 degree radiation-associated esophagitis; ≥ 3 degree radiation-associated lymphopenia.
Secondary outcomes (8)
- measure
- Local recurrence rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
Show eligibility criteria text
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 breast, lymph-drainage regions or adjacent areas before; 4. Concurrent active connective tissue disease; 5. Other malignancies, which affect patient life expectancy (except adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder neoplasms (no more than T1), early stage thyroid carcinoma); 6. Severe comorbidities or active disease (Poorly controlled heart disease: New York Classification of Cardiac Function ≥ Grade 2, active coronary heart disease, unstable angina pectoris, arrhythmia requiring medical treatment/persistent refractory hypertension; Myocardial infarction, stroke within six months; Poorly controlled diabetes persists. Fasting blood glucose ≥ 10mmol/L, 2 hours postprandial blood glucose ≥ 13 mmol/L. Poorly controlled psychosis develops or worsens within six months; Active infection; Positive for antibodies to HIV). 7. Pregnant or breast-feeding.
References
Publications (0)
Data not yet available
No reference posted for this study.