Radiotherapy options 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)
This study is testing a new type of radiation treatment for low-risk breast cancer patients to see if it can be safely given after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 35 Years and up |
| Sex | Female |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05762900 on ClinicalTrials.gov |
What this trial studies
This phase II study investigates the feasibility of ultra-hypofractionated radiotherapy, with or without a simultaneous integrated boost, for patients with low-risk breast cancer who have undergone breast-conserving surgery or mastectomy. Participants will receive radiation treatment consisting of 5.2Gy for 5 fractions to prophylactic areas and a 6Gy boost to the tumor bed or high-risk volumes. The primary endpoint is to assess acute toxicity of grade 2 or higher within 12 weeks post-treatment.
Who should consider this trial
Good fit: Ideal candidates include women diagnosed with invasive or non-invasive breast cancer who have undergone appropriate surgical procedures and meet specific health criteria.
Not a fit: Patients with nodal involvement or previous radiation to the affected area may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce radiation side effects while maintaining effective treatment for low-risk breast cancer patients.
How similar studies have performed: While similar approaches have been explored, this specific method of ultra-hypofractionated radiotherapy with simultaneous boost is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Beijing
- National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Shu-Lian Wang, M.D.
- Email: wangsl@cicams.ac.cn
- Phone: 8610-87788290
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.