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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03017404
• Other study ID #: CSPC-DMS-BC-02
• Status: Completed
• Phase: N/A
• First received: January 9, 2017
• Last updated: January 10, 2017
• Start date: May 2015
• Est. completion date: July 2016

Study information

• Verified date: January 2017
• Source: Hebei Medical University Fourth Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Female patients newly diagnosed breast cancer=18 and =70 years of age;

• Karnofsky performance status=70 and measurable or evaluable;

• Stages ?a-?C;

• 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Doxorubicin Hydrochloride Liposome Injection

• Cyclophosphamide

• docetaxel

Locations

Country	Name	City	State
China	Fourth Hospital of Hebei Medical University	Shi Jiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Fourth Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum tolerated dose		4 cycles (each cycle is 21 days) of chemotherapy	No