OncoMatch/Clinical Trials/NCT07203729

The Efficacy and Safety of Trastuzumab Rezetecan (SHR-A1811) in HER2-Low Unresectable/Metastatic Breast Cancer Patients With Visceral Crisis

Is NCT07203729 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Trastuzumab Rezetecan and Chemotherapy of Physician's Choice for her2-low unresectable/metastatic breast cancer complicated with visceral crisis.

Phase 2RecruitingCancer Institute and Hospital, Chinese Academy of Medical SciencesNCT07203729Data as of May 2026

Treatment: Trastuzumab Rezetecan · Chemotherapy of Physician's Choice — The goal of this clinical trial is to learn if Trastuzumab Rezetecan (SHR-A1811) is safe and tolerable for patients with HER2-Low unresectable/metastatic breast cancer complicated with visceral crisis. Participants will take Trastuzumab Rezetecan every three weeks, until disease progression or intolerable toxicity.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) low expression (low)

Disease stage

Metastatic disease required

Prior therapy

Max 1 prior line

Cannot have received: antibody-drug conjugate

Lab requirements

Blood counts

Neutrophil count (ANC) ≥ 1,500/mm³ (1.5 × 10⁹/L); Platelet count (PLT) ≥ 80 ×10^9/L; Hemoglobin (Hb) ≥ 80 g/L

Cardiac function

Severe heart disease or cardiac discomfort, including but not limited to: a) A history of heart failure or systolic dysfunction (LVEF < 50%); b) High-risk angina pectoris requiring treatment or cardiac arrhythmias; c) Clinically significant valvular heart disease; d) ECG findings indicating transmural myocardial infarction; e) Poorly controlled hypertension

Sufficient bone marrow function, defined as follows: a) Neutrophil count (ANC) ≥ 1,500/mm³ (1.5 × 10⁹/L); b) Platelet count (PLT) ≥ 80 ×10^9/L; c) Hemoglobin (Hb) ≥ 80 g/L; Have severe heart disease or cardiac discomfort, including but not limited to the following conditions: a) A history of heart failure or systolic dysfunction (LVEF < 50%); b) High-risk angina pectoris requiring treatment or cardiac arrhythmias; c) Clinically significant valvular heart disease; d) ECG findings indicating transmural myocardial infarction; e) Poorly controlled hypertension.

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

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