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OncoMatch/Clinical Trials/NCT07100600

Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases

Is NCT07100600 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Trastuzumab Rezetecan for her2-positive advanced breast cancer.

Phase 2RecruitingHenan Cancer HospitalNCT07100600Data as of May 2026

Treatment: Trastuzumab RezetecanA total of 224 subjects of HER2-positive advanced breast cancer with brain metastases are planned to be enrolled. Eligible subjects will be randomly assigned in a 1:1 ratio to the group receiving Trastuzumab Rezetecan combined with radiotherapy or the group receiving Trastuzumab Rezetecan monotherapy until disease progression, intolerable toxicity, withdrawal of informed consent, or the study determines that treatment must be terminated (whichever occurs first).

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) overexpression

Disease stage

Metastatic disease required

Prior therapy

Cannot have received: antibody-drug conjugate (trastuzumab deruxtecan, DS-8201a)

Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor

Lab requirements

Blood counts

adequate function of major organs

Kidney function

adequate function of major organs

Liver function

adequate function of major organs

Cardiac function

Suffering from heart disease that is not well controlled or having clinical symptoms [excluded]

Adequate function of major organs; Suffering from heart disease that is not well controlled or having clinical symptoms [excluded]

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

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