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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 65 participants in total. It began in 2022-10-25 with a primary completion date of 2025-10-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05762900 clinical trial?
This trial is open to female participants only, aged 35 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05762900 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05762900 currently recruiting?
Yes, NCT05762900 is actively recruiting participants. Contact the research team at wangsl@cicams.ac.cn for enrollment information.
Where is the NCT05762900 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05762900 clinical trial?
NCT05762900 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 65 participants.
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