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

Hebei Medical University

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Doxorubicin Hydrochloride Liposome Injection; Drug: docetaxel; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT03017404

CSPC-DMS-BC-02

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 4 patient groups

treatment group:35 mg/m(2)

Experimental group

Description:

Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy

Treatment:

Drug: Cyclophosphamide

Drug: docetaxel

Drug: Doxorubicin Hydrochloride Liposome Injection

treatment group:40 mg/m(2)

Experimental group

Description:

Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy

Treatment:

Drug: Cyclophosphamide

Drug: docetaxel

Drug: Doxorubicin Hydrochloride Liposome Injection

treatment group:45 mg/m(2)

Experimental group

Description:

Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy

Treatment:

Drug: Cyclophosphamide

Drug: docetaxel

Drug: Doxorubicin Hydrochloride Liposome Injection

treatment group:50 mg/m(2)

Experimental group

Description:

Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy

Treatment:

Drug: Cyclophosphamide

Drug: docetaxel

Drug: Doxorubicin Hydrochloride Liposome Injection