A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection for Patients With Breast Cancer

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hebei Medical University Fourth Hospital
• Treatments: Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin

Criteria

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