Advanced Breast Cancer
Conditions
Brief summary
A multicenter, randomized, open-lable, single-dose, two-cycle, double-cross bioequivalence study comparing the pharmacokinetic profile of LY01612 (Doxorubicin hydrochloride liposome injection) and CAELYX® in Chinese subjects with advanced breast cancer
Interventions
Doxorubicin hydrochloride liposome injection was administered intravenously for 90min (±3min) with an infusion pump on day 1 and day 29 of the trial. Doxorubicin hydrochloride liposome injection was diluted with 250mL 5% glucose injection.
Sponsors
Luye Pharma Group Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntary agreement to provide written informed consent; 2. Patients aged ≥18 years and ≤75 years with locally advanced or metastatic breast cancer diagnosed by histology or cytology，and who may benefit from monotherapy of Doxorubicin liposomes; 3. Life expectancy of at least 3 months; Eastern Cooperative Oncology Group (ECOG) performance status (PS)\<2; 4. adequate bone marrow function \[leukocyte ≥3,000/mm3, absolute neutrophil count (ANC) ≥1,500/mm3, hemoglobin ≥90g/L, and platelet count ≥90,000/mm3； 5. adequate renal function (serum creatinine ≤1.5×Institutional upper limit of normal (ULN)); 6. adequate coagulation function \[prothrombin time (PT), activated partial thromboplastin time (APTT) ≤1.5×ULN\]; 7. adequate hepatic function \[aspartate aminotransferase (AST), alanine aminotransferase (ALT) level ≤ 2.5×ULN (or ≤5×ULN for subjects with liver metastases), and total bilirubin level ≤ 1.5×ULN (or ≤ 3×ULN for subjects with liver metastases).
Exclusion criteria
1. Patients with a diagnosis of severe cardiovascular, lung, liver, kidney, gastrointestinal, endocrine, immune system, skin, musculoskeletal, neurological or psychiatric conditions that the researchers did not consider appropriate for inclusion; 2. With a history of myocardial infarction, unstable angina pectoris, coronary revascularization, New York Heart Association (NYHA) grade ≥Ⅱ cardiac insufficiency, severe pericardial disease, and severe unstable ventricular arrhythmia, cerebrovascular accident or transient cerebral ischemia or pulmonary embolism within 6 months before randomization; 3. Unstable brain metastases; 4. Electrocardiogram (ECG) QTC \>480ms; left ventricular ejection fraction \<50% or below the lower limit of study center value; 5. The total cumulative dose of doxorubicin was ﹥350mg/m2 before screening； 6. Persistent or active infection requiring systemic treatment; 7. Pregnancy or breast feeding; 8. Other situations that investigators consider as contra-indication for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma maximum concentration (Cmax) of encapsulated doxorubicin. | from baseline to day 56 |
| Area under Plasma d concentration-time curves of encapsulated doxorubicin | from baseline to day 56 |
| plasma maximum concentration (Cmax) of unencapsulated doxorubicin. | from baseline to day 56 |
| Area under Plasma concentration-time curves of unencapsulated doxorubicin. | from baseline to day 56 |
Secondary
| Measure | Time frame |
|---|---|
| Encapsulated doxorubicin、unencapsulated doxorubicin and total doxorubicin t1/2z | from baseline to day 56 |
| plasma maximum concentration（Cmax） of total doxorubicin； | from baseline to day 56 |
| Adverse event | from baseline to day 56 |
| Area under plasma concentration-time curves of total doxorubicin； | from baseline to day 56 |
| Partial area under plasma concentration-time curves （AUC0-48h and AUC48h-t）of encapsulated doxorubicin | from baseline to day 56 |
| Encapsulated doxorubicin、unencapsulated doxorubicin and total doxorubicin Tmax | from baseline to day 56 |
Countries
China
Outcome results
None listed