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

NCT ID: NCT03017404

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-07-31

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

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment group:35 mg/m(2)

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

Group Type: EXPERIMENTAL

Doxorubicin Hydrochloride Liposome Injection

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

treatment group:40 mg/m(2)

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

Group Type: EXPERIMENTAL

Doxorubicin Hydrochloride Liposome Injection

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

treatment group:45 mg/m(2)

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

Group Type: EXPERIMENTAL

Doxorubicin Hydrochloride Liposome Injection

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

treatment group:50 mg/m(2)

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

Group Type: EXPERIMENTAL

Doxorubicin Hydrochloride Liposome Injection

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

Interventions

Doxorubicin Hydrochloride Liposome Injection

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

CSPC-DMS-BC-02

Identifier Type: -

Identifier Source: org_study_id