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Trial intelligence / Profile preview
HRS-2189 combinations in advanced breast cancer
NCT06679036Phase 2
Key facts
- Status
- Recruiting
- Start
- Jan 2025
- Primary completion
- Oct 2026
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- hrs-2189
- Conditions
- breast cancer
01
Overview
Phase 2, open-label trial of hrs-2189 in breast cancer, sponsored by Shandong Suncadia Medicine Co., Ltd. Primary endpoints: Adverse Events and Serious Adverse Events, Dose-Limited Toxicity at 28 days and 3 more. Started Jan 2025; status: recruiting.
02
Design
- Study design
- Non-randomizedOpen-label
03
Who it enrols
Adult female patients with advanced unresectable or metastatic breast cancer who have progressed on prior endocrine therapy, CDK4/6 inhibitors, or chemotherapy.
04
Endpoints
Primary
Adverse Events and Serious Adverse Events
Dose-Limited Toxicity
Maximum Tolerated Dose
Recommended Phase II Dose
Objective Response Rate
Secondary
Maximum Steady-State Plasma Concentration
Time to Maximum Steady-State Plasma Concentration
Minimum Steady-State Plasma Concentration
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