Doxorubicin Hydrochloride Liposome Injection Combination With Cyclophosphamide vs Pirarubicin Combination With Cyclophosphamide in Patients With Locally Advanced Breast Cancer

Breast Cancer Clinical Trial

Official title:

The Efficacy and Safety of Doxorubicin Hydrochloride Liposome Injection Plus Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer ：a Randomised Multicentre, Open-label Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02903524
• Other study ID #: CSPC-DMS-BC-03
• Status: Recruiting
• Phase: Phase 4
• First received: September 13, 2016
• Last updated: September 15, 2016
• Start date: September 2016
• Est. completion date: December 2018

Study information

• Verified date: September 2016
• Source: Hebei Medical University Fourth Hospital
• Contact: Geng Cuizhi, archiater
• Phone: 0311-66696310
• Email: gengcuizhi[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Evaluate the efficacy and safety of Doxorubicin Hydrochloride Liposome Injection Plus Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer Patients

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Female patients with age between 18 and 70 years.

• Newly diagnosed breast cancer, stages IIb-IIIc.

• KPS performance status=70.

• Measurable disease according to RECIST version 1.1.

• Normal cardiac function confirmed by baseline left ventricular ejection fraction (LVEF)=50%.

• Adequate bone marrow reserve (WBC=4.0×10(9)/L, neutrophils=2.0×10(9)/L, platelets=100×10(9)/L,and hemoglobin=90g/L).

• Adequate hepatic and renal function.

• AST and ALT = 2×institutional upper limit of normal;alkaline phosphatase = 2×institutional upper limit of normal;bilirubin = institutional upper limit of normal.

• Serum creatinine=44 µmol/L and =133 µmol/L.

• Written informed consent are acquired.

• Not in pregnancy or the pregnancy tests of females is negative.

Exclusion Criteria:

• Severe heart failure (NYHA grade II or higher).

• Active and uncontrolled severe infection.

• Have accepted any other anti-tumor drug within 30 days before the first dose or

• received radiation treatment.

• 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 and cyclophosphamide

• pirarubicin and cyclophosphamide

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	pathological complete response		until the completion of 4 cycles (each cycle is 21 days) of chemotherapy	No