A Phase II Study of Abraxane Gemcitabine Combination in Patients With Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

A Phase II Study of Abraxane Combined With Gemcitabine in the Patients With Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01550848
• Other study ID #: Fudan BR2011-07
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2012
• Last updated: September 8, 2015
• Start date: January 2012
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.

Description:

This study is to investigate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Female between 18 and 70 years old;

• Patients with histologic proved metastatic breast cancer, unsuitable to be treated with surgery;

• ECOG (Eastern Cooperative Oncology Group) 0~1;

• Normal functions with heart, liver,renal and bone marrow:WBC=3.5×109/L;Hb=90 g/L;plt=100×109/L;

• Got ICF (Informed Consent Form) before enrollment;

• Life expectancy more than 12 weeks

Exclusion Criteria:

• Pregnant or breast-feeding women or positive serum pregnancy test;

• Uncontrolled brain metastases. Patients with brain metastases must be locally treated and the disease must be stable for at least one month at the time of enrolling;

• Participation in any investigational drug study within 4 weeks preceding treatment start;

• Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin or a contralateral breast cancer;

• Serious uncontrolled intercurrent infections;

• Poor compliance

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Abraxane and Gemcitabine
ABX (Abraxane) 125 mg/m2,intravenous infusion,30min,day 1, 8, 15 GEM (Gemcitabine) 800 mg/m2,intravenous infusion,30min,day 1, 8, 15

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate		8 weeks	No
Secondary	number of adverse events		6 months	Yes