RecruitingPhase 1Phase 2NCT06679036

A Trial of HRS-2189 in Combination With Fluvastatin±HRS-6209, or HRS-8080±HRS-6209, or HRS-6209+HRS-1358 in Breast Cancer Patients

An Open, Multicenter Phase Ib/II Clinical Study on the Safety, Tolerance, Pharmacokinetics, and Initial Efficacy of HRS-2189 in Combination With Fluvastatin±HRS-6209, or HRS-8080±HRS-6209, or HRS-6209+HRS-1358 in Patients With Advanced Unresectable or Metastatic Breast Cancer


Sponsor

Shandong Suncadia Medicine Co., Ltd.

Enrollment

300 participants

Start Date

Jan 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in adults. To explore the reasonable dosage of dexmedetomidine hydrochloride nasal spray for preoperative sedation.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests various combinations of investigational drugs — including HRS-2189, HRS-6209, HRS-8080, and HRS-1358 — in women with advanced or metastatic breast cancer whose cancer progressed after hormone therapy with or without CDK4/6 inhibitor drugs. **You may be eligible if...** - You have advanced (unresectable) or metastatic breast cancer confirmed by biopsy - Your cancer progressed after prior endocrine (hormone) therapy, with or without CDK4/6 inhibitors - You are postmenopausal (or premenopausal with ovarian suppression) - Your overall health meets the required performance status (ECOG 0–1) **You may NOT be eligible if...** - Your cancer is triple-negative (hormone-receptor negative, HER2-negative) - You have uncontrolled brain metastases - You have severe organ dysfunction - You are pregnant or breastfeeding - You have active serious infections or significant other medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHRS-2189

HRS-2189

DRUGFluvustat

Fluvustat

DRUGHRS-8080

HRS-8080

DRUGHRS-6209

HRS-6209

DRUGHRS-1358

HRS-1358


Locations(2)

Harbin Medical University Affiliated Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

View Full Details on ClinicalTrials.gov

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NCT06679036


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