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

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

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: docetaxel; Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride Liposome Injection

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shi Jiazhuang, Hebei, China, 050019
      • Fourth Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: docetaxel; Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride Liposome Injection
Experimental: 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	Drug: docetaxel; Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride Liposome Injection
Experimental: 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	Drug: docetaxel; Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride Liposome Injection
Experimental: 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	Drug: docetaxel; Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride Liposome Injection

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hebei Medical University Fourth Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: January 9, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimate): January 11, 2017

Study Record Updates

• Last Update Posted (Estimate): January 11, 2017
• Last Update Submitted That Met QC Criteria: January 10, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Docetaxel; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin
• Other Study ID Numbers: CSPC-DMS-BC-02