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OncoMatch/Clinical Trials/NCT05059379

Medial vs. Entire Supraclavicular Lymph Node Radiation Therapy for Patients With Invasive Breast Cancer

Is NCT05059379 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies non-drug interventions for breast cancer.

Phase 3RecruitingFudan UniversityNCT05059379Data as of May 2026

Locally advanced breast cancer has high-risk local regional recurrence after surgery. Radiotherapy could reduce the local regional recurrence and improve disease free survival and overall survival. Regional lymph node irradiation is the important part of breast cancer radiotherapy. However, there are some controversies about regional lymph node delineation, especially the supraclavicular irradiation volume. Many studies had confirmed that posterolateral region of the supraclavicular fossa (also named Posterior neck lymph node) had a high risk involvement based on the mapping of recurrence nodes. This randomized phase III trial compares medial supraclavicular lymph node irradiation with entire supraclavicular lymph node irradiation in patients with pathologically positive axillary lymph node and high risk of recurrence after mastectomy or breast conservative surgery. It is not yet known if radiation works better with entire supraclavicular fossa than medial supraclavicular fossa.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Allowed: HER2 (ERBB2) positive

Allowed: ESR1 positive

Allowed: PR (PGR) positive

Disease stage

Required: Stage T1-4, N0-3A/B, T1-3N2-3A/B, M0, CLINICAL STAGE III, T1-4N1-3A/BM0

Excluded: Stage N3C, T4 OR INFLAMED BREAST CANCER WITH NO GOOD DOWNSTAGE BY NEOADJUVANT CHEMOTHERAPY, DISTANT METASTASIS

Initial clincial diagonosis stage is T1-4, N0-3a/b, M0: If neoadjuvant chemotherapy was not administered: pathological stage is T1-3N2-3a/b, M0; If neoadjuvant chemotherapy was administered:clinical stage III or pathological stage is T1-4N1-3a/bM0.

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: chemotherapy — neoadjuvant and/or adjuvant

Should receive ≥6 cycles standard neoadjuvant and/or adjuvant chemotherapy (taxane and/or anthracycline based)

Must have received: taxane — neoadjuvant and/or adjuvant

Should receive ≥6 cycles standard neoadjuvant and/or adjuvant chemotherapy (taxane and/or anthracycline based)

Must have received: anthracycline — neoadjuvant and/or adjuvant

Should receive ≥6 cycles standard neoadjuvant and/or adjuvant chemotherapy (taxane and/or anthracycline based)

Cannot have received: radiotherapy

History of radiotherapy

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

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