Actively Recruiting
Investigation of Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-03-28
32
Participants Needed
2
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the pharmacokinetics and safety of SHR-A1811 monotherapy and in combination with Ritonavir or Itraconazole in subjects with HER2-expressing advanced breast cancer.
CONDITIONS
Official Title
Investigation of Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female with HER2-expressing advanced breast cancer
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- Absolute neutrophil count (ANC) 1.5 x 10^9/L (1,500/mm3) or higher
- Platelet count 100 x 10^9/L (100,000/mm3) or higher
- Hemoglobin level 9.0 g/dL (90 g/L) or higher
- Albumin level 3.0 g/dL or higher
- Total serum bilirubin 1.5 times the upper limit of normal (ULN)
- Prothrombin time and activated partial thromboplastin time (aPTT) 1.5 times ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5 times ULN (or 5 times ULN for patients with liver metastasis)
- Serum creatinine 1.5 times ULN or creatinine clearance 60 mL/min
- QTcF interval 470 milliseconds
- Left ventricular ejection fraction (LVEF) 50%
You will not qualify if you...
- Active untreated central nervous system metastases or brain metastases not stable for at least 1 month after treatment
- Severe or unstable heart diseases including severe angina, symptomatic congestive heart failure (NYHA II-IV), significant arrhythmias requiring treatment, or recent myocardial infarction within 6 months
- Known severe allergic reactions to SHR-A1811 components or hypersensitivity to humanized monoclonal antibodies such as trastuzumab or pertuzumab
- Contraindications to taking ritonavir or itraconazole
- Conditions affecting oral medication absorption such as inability to swallow, chronic diarrhea, intestinal obstruction, gastrectomy, or active gastrointestinal diseases affecting drug metabolism or excretion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510200
Actively Recruiting
2
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
Research Team
M
Meijing Yu
CONTACT
Y
Yanyan Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here