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OncoMatch/Clinical Trials/NCT06757621

Hypofractionated Postoperative Regional Nodal Irradiation for Patients With Intermediate-risk Breast Cancer

Is NCT06757621 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies non-drug interventions for breast carcinoma.

Phase 3RecruitingCancer Institute and Hospital, Chinese Academy of Medical SciencesNCT06757621Data as of May 2026

The role of postoperative regional nodal irradiation (RNI) for T1-2N1 intermediate-risk breast cancer is controversial, and there is a lack of class I evidence of a survival benefit from RNI. A number of retrospective studies of breast cancer patient been undertaken to risk stratify, analyse site of recurrence and assess the role of radiotherapy. RNI is currently recommended for patients at high risk of recurrence, but prospective studies in other patients are needed to assess the role of RNI. Two randomised phase III trials have confirmed the safety and efficacy of 15-fraction hypofractionated radiotherapy, while 5-fraction super-hypofractionated radiotherapy to further shorten the course of radiotherapy is a hotspot of current research. The present study aimed to investigate whether RNI improves the outcome of intermediate-risk breast cancer patients; and to assess the efficacy and toxicity of 15-fraction hypofractionated and 5-fraction super-hypofractionated radiotherapy.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Disease stage

Required: Stage PT1-2N1M0, CT1-2N1-2M0, YPT0-2N0M0 (8th edition)

Excluded: Stage DISTANT METASTASES

Tumor staging: ... pT1-2N1M0 ... cT1-2N1-2M0→ypT0-2N0M0 ... restaging according to the 8th edition of the staging criteria

Prior therapy

Must have received: neoadjuvant chemotherapy — neoadjuvant

patients with neoadjuvant chemotherapy: ... receiving ≥6 cycles of neoadjuvant chemotherapy

Cannot have received: radiation therapy

Previous radiotherapy to the chest

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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