Phase II Study of SHR-A1811 for Ultra-Low HER2 Advanced Breast Cancer

This is a single-center, single-arm, open-label phase II exploratory study. A total of 30 patients aged 18-75 years with ECOG PS 0-1, pathologically confirmed advanced breast cancer with ultra-low HER2 expression will be enrolled. Eligible patients must have at least one measurable lesion and have received 1-2 lines of prior systemic therapy for advanced disease. All participants receive intravenous SHR-A1811 at 4.8 mg/kg every 3 weeks, until disease progression, intolerable adverse events or other discontinuation criteria. The primary endpoint is objective response rate (ORR). Secondary endpo

Trial Details

NCT ID

NCT07817082

Phase

PHASE2

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Status

RECRUITING

Cancer Type

Breast Cancer

Interventions

• SHR- A1811

Locations (sample)

• Tianjin, China|39.14222,117.17667

Key Eligibility Criteria

• Female subjects, aged ≥18 years and ≤75 years;
• ECOG performance status 0-1;
• Expected survival of no less than 3 months;
• Histologically documented breast cancer:

For full eligibility, visit ClinicalTrials.gov.

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