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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 (Jun 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 Jun 2026Location: China

Treatment: Trastuzumab Rezetecan · Chemotherapy of Physician's ChoiceThe 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

Treatments studied

Targeted therapy

Trastuzumab Rezetecan

Other

Chemotherapy of Physician's Choice

Cancer type

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) low expression (low)

Disease stage

Metastatic disease required

Demographics

Ages ≤ 75
Female only

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.

Frequently asked questions

Is NCT07203729 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior antibody-drug conjugate disqualifies patients from enrollment.

Does this trial require ERBB2?

Yes, ERBB2 low expression is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Is this trial open to male patients?

No. This trial enrolls female patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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