Breast Cancer
Conditions
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
Interventions
Sponsors
Hebei Medical University Fourth Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum tolerated dose | 4 cycles (each cycle is 21 days) of chemotherapy |
Countries
China
Outcome results
None listed