NCT07527689 Ultra-Hypofractionated vs Moderate Hypofractionated Radiotherapy for Regional Lymph Nodes in High Risk Breast Cancer
| NCT ID | NCT07527689 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ruijin Hospital |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,950 participants |
| Start Date | 2026-04-22 |
| Primary Completion | 2034-03-30 |
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.
This trial targets 1,950 participants in total. It began in 2026-04-22 with a primary completion date of 2034-03-30.
⚠ 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
For patients with breast cancer, regional nodal irradiation (RNI) can significantly reduce the risks of recurrence and mortality. Moderate hypofractionated regimens (40 to 42.5 Gy in 15 to 16 fractions over 3 weeks) is the established standard of care for RNI. Nevertheless, for the majority of patients, a three - week treatment duration is still regarded as lengthy. Although the ultra-hypofractionated regimen (26 Gy in 5 fractions over 1 week) has been proven non-inferior to the moderate hypofractionated regimen for whole breast irradiation, unambiguous evidence supporting its use in comprehensive RNI remains lacking, especially in high risk patients requiring internal mammary node irradiation (IMNI). This prospective, non-inferiority trial is designed to address this evidence gap by evaluating whether a one-week, ultra-hypofractionated regimen (26 Gy in 5 fractions) is non-inferior to the three-week regimen (40 Gy in 15 fractions) for comprehensive RNI, including IMNI.
Eligibility Criteria
Inclusion Criteria: 1. Provide a signed and dated informed consent form (ICF) before the initiation of any trial-specific procedures. 2. Age ≥ 18 years. 3. Histologically confirmed invasive breast cancer. 4. Have received breast-conserving surgery or mastectomy with axillary staging, including sentinel lymph node biopsy, targeted axillary dissection and/or axillary lymph node dissection. 5. Tumor stage is classified as T1, T2, or T3, as defined by the AJCC Cancer Staging Manual, 8th Edition. 6. Meeting at least one of the following conditions: 1. Pathological nodal status of pN2 or pN3a; 2. Pathological nodal status of pN1 with one or more of the following high-risk factors: (I), Age \< 40 years. (II), Tumor location in the central or inner quadrant. (III), Estrogen Receptor (ER) negative. (IV), Presence of lymphovascular invasion (LVI). (V), Histological grade III. (VI), Patients presenting with clinical stage cN2-3a before neoadjuvant treatment. 7. Pathologically negative surgical margins, defined as "no ink on tumor." 8. Karnofsky Performance Status (KPS) score ≥ 80. 9. Documented biomarker status for Estrogen Receptor (ER), Progesterone Receptor (PR), HER2, and Ki-67. 10. Sufficient wound healing from surgery, with no signs of active infection at the intended radiation site. Exclusion Criteria: 1. Nodal stage is classified as N3b or N3c, as defined by the AJCC Cancer Staging Manual, 8th Edition. 2. Has undergone or is planning immediate breast reconstruction with a permanent implant or tissue expander. 3. Evidence of distant metastatic disease. 4. Diagnosis of synchronous bilateral invasive breast cancer or a history of prior invasive cancer in either breast. 5. History of prior radiation therapy to the chest, axillary, or supraclavicular regions. 6. Known active collagen vascular diseases, particularly systemic lupus erythematosus or scleroderma, which are contraindications to radiotherapy. 7. Presence of any severe, uncontrolled co-morbidity or medical condition that, in the investigator's judgment, would render the participant unsuitable for the study, compromise protocol compliance, or confound the interpretation of study results. 8. History of any other malignancy within the 5 years before enrollment, with the exception of adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix. 9. Participants who are pregnant or lactating at the time of study enrollment. (Note: In accordance with the standards of each participating institution, women of childbearing age are required to undergo pregnancy testing within 2 weeks prior to randomization.)
Contact & Investigator
Jia-Yi Chen, PhD, MD
PRINCIPAL INVESTIGATOR
Department of Radiation Oncology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Frequently Asked Questions
Who can join the NCT07527689 clinical trial?
This trial is open to female participants only, aged 18 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.
Is NCT07527689 currently recruiting?
Yes, NCT07527689 is actively recruiting participants. Contact the research team at cl11879@rjh.com.cn for enrollment information.
Where is the NCT07527689 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07527689 clinical trial?
NCT07527689 is sponsored by Ruijin Hospital. The principal investigator is Jia-Yi Chen, PhD, MD at Department of Radiation Oncology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 1,950 participants.
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