A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection for Patients With Breast Cancer
Not Applicable
Completed
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT03017404
- Lead Sponsor
- Hebei Medical University Fourth Hospital
- Brief Summary
To study the maximum tolerated dose of Doxorubicin Hydrochloride Liposome Injection combination with cyclophosphamide and sequential treatment of docetaxel for patients with locally advanced breast cancer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 18
Inclusion Criteria
- Female patients newly diagnosed breast cancer≥18 and ≤70 years of age;
- Karnofsky performance status≥70 and measurable or evaluable;
- Stages Ⅲa-ⅢC;
- Baseline left ventricular ejection fraction (LVEF) ≥ 50%;
- Adequate marrow function (WBC count> 4.0×10(9)/L, neutrophil> 2.0×10(9)/L, platelet count > 100×10(9)/L，hemoglobin > 90g/L );
- AST and ALT ≤1.5× institutional upper limit of normal, alkaline phosphatase
- ≤2.5×institutional upper limit of normal，bilirubin ≤institutional upper limit of normal;
- Serum creatinine ≥ 44µmol/L and ≤ 133 µmol/L;
- Expected lifetime ≥ 12 months;
- Pregnancy tests of reproductive age women is negative;
- All patients provided written informed consent.
Exclusion Criteria
- Distant metastasis;
- Severe heart failure (NYHA grade II or higher);
- Active and uncontrolled severe infection;
- Hypersensitivity to anthracycline therapy or a history of severe hypersensitivity reactions to products containing liposomal doxorubicin and docetaxel;
- Have accepted any other anti-tumor drug within 30 days before the first dose of doxorubicin hydrochloride liposome or doxorubicin;
- Pregnancy or breast feeding;
- Other situations that investigators consider as contra-indication for this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description treatment group:40 mg/m(2) Doxorubicin Hydrochloride Liposome Injection Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy treatment group:35 mg/m(2) docetaxel Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy treatment group:45 mg/m(2) Doxorubicin Hydrochloride Liposome Injection Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy treatment group:50 mg/m(2) Doxorubicin Hydrochloride Liposome Injection Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy treatment group:35 mg/m(2) Doxorubicin Hydrochloride Liposome Injection Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy treatment group:50 mg/m(2) docetaxel Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy treatment group:35 mg/m(2) Cyclophosphamide Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy treatment group:40 mg/m(2) Cyclophosphamide Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy treatment group:40 mg/m(2) docetaxel Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy treatment group:45 mg/m(2) docetaxel Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy treatment group:50 mg/m(2) Cyclophosphamide Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy treatment group:45 mg/m(2) Cyclophosphamide Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy
- Primary Outcome Measures
Name Time Method maximum tolerated dose 4 cycles (each cycle is 21 days) of chemotherapy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fourth Hospital of Hebei Medical University
🇨🇳Shi Jiazhuang, Hebei, China