Actively Recruiting
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
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-03-02
300
Participants Needed
2
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients with advanced unresectable or metastatic breast cancer confirmed by histopathology or cytopathology
- ECOG physical condition score of 0-1
- Menopausal status
- Previous treatments including adjuvant endocrine therapy with or without CDK4/6 inhibitors and chemotherapy within specified time frames
- Disease progression confirmed by imaging during or after last systemic anti-tumor treatment (for efficacy expansion stage)
- At least one measurable extracranial lesion meeting RECIST v1.1 at baseline
- Expected survival longer than 3 months
- Good functional status of 8 organs
- Specified intervals since last treatments including nitrosourea, mitomycin C, cytotoxic drugs, endocrine therapy, immunotherapy, targeted therapy, surgery, and radiotherapy
- Female participants with fertility must use effective contraception during and for 7 months after treatment and have a negative serum HCG test within 7 days prior to enrollment
- Voluntary participation with ability and willingness to comply with study visits and procedures and signed informed consent
You will not qualify if you...
- Active (uncontrolled or symptomatic) brain metastases, cancerous meningitis, spinal cord compression, or history of primary CNS tumors, except treated and asymptomatic brain metastases with confirmed imaging
- Severe cardiovascular disease including congestive heart failure NYHA Class >2, recent severe or unstable angina, myocardial ischemia requiring long-term medication, acute myocardial infarction within 6 months, significant arrhythmias, atrial fibrillation, coronary or peripheral artery bypass grafts, or cerebrovascular symptoms
- Conditions affecting oral medication intake or active gastrointestinal diseases affecting drug absorption
- Uncontrollable third space effusions or cancerous lymphedema
- Pregnancy, nursing, or planning pregnancy during the study
- Significant liver disease, untreated active hepatitis B or C
- Uncontrolled chronic systemic diseases such as severe lung, liver, kidney, or heart diseases
- Active autoimmune diseases, immune deficiency, history of organ transplantation, or immunosuppressive therapy
- Active infectious tuberculosis requiring treatment
- Other malignancies within past 5 years except certain fully cured skin or cervical cancers
- Use of strong or moderate CYP3A4 inhibitors or inducers shortly before first dose
- History of neurological or psychiatric disorders or substance abuse
- Expected to receive other anti-tumor treatments during the study
- Serious physical or laboratory abnormalities increasing risk or interfering with study
- Prior anti-tumor treatment toxicities except alopecia or some tolerable chronic Grade II toxicities
- Allergies to any study drug or excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Harbin Medical University Affiliated Cancer Hospital
Harbin, Heilongjiang, China, 150081
Actively Recruiting
2
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
Research Team
X
Xia Zhang, M.M
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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