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

Study Overview
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Brief Summary
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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

Official Title
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A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection in Neoadjuvant Chemotherapy for Patients With Locally Advanced Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Doxorubicin Hydrochloride Liposome Injection
* Drug: Cyclophosphamide
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group:35 mg/m(2)<br>Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy | Drug: Doxorubicin Hydrochloride Liposome Injection<br> <br> Drug: Cyclophosphamide<br> <br> Drug: docetaxel<br> <br> |
| Experimental: treatment group:40 mg/m(2)<br>Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy | Drug: Doxorubicin Hydrochloride Liposome Injection<br> <br> Drug: Cyclophosphamide<br> <br> Drug: docetaxel<br> <br> |
| Experimental: treatment group:45 mg/m(2)<br>Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy | Drug: Doxorubicin Hydrochloride Liposome Injection<br> <br> Drug: Cyclophosphamide<br> <br> Drug: docetaxel<br> <br> |
| Experimental: treatment group:50 mg/m(2)<br>Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy | Drug: Doxorubicin Hydrochloride Liposome Injection<br> <br> Drug: Cyclophosphamide<br> <br> Drug: docetaxel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum tolerated dose |  | 4 cycles (each cycle is 21 days) of chemotherapy |