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OncoMatch/Clinical Trials/NCT04646564

Radiotherapy for Extracranial Oligometastatic Breast Cancer

Is NCT04646564 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies standard of care for breast cancer metastatic.

Phase 3RecruitingChinese Academy of Medical SciencesNCT04646564Data as of May 2026

Treatment: standard of careMore and more evidence suggests that local radiotherapy can improve the outcomes for patients with oligometastatic disease. The purpose of this study is to assess the impact of radiotherapy, compared with standard systemic therapy alone, on survival, local control and toxicities in patients with extracranial oligometastatic breast cancer. Eligible patients are randomized in a 1:2 ratio between the control arm (standard systemic therapy), and the WLRT arm (standard systemic therapy + radiotherapy). Randomization will be stratified by three factors: visceral metastasis (yes vs.no), number of metastases(≤2 vs. \>2), hormone receptor(positive vs. negative). SBRT technique is preferred. During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: systemic therapy

Have received or plan to receive systemic therapy

Cannot have received: radiation therapy

Exception: for target area

Have received prior radiotherapy for target area

Lab requirements

Liver function

moderate/severe liver dysfunction (Child Pugh B or C) from liver metastases [excluded]

Have adequate organ function; Have moderate/severe liver dysfunction (Child Pugh B or C) from liver metastases [excluded]

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

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