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

Phase 2

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Abraxane and Gemcitabine

• Registration Number: NCT01550848
• Lead Sponsor: Fudan University

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-27
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-12
• Primary Completion: 2014-07
• Study Completion: 2015-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-08
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Abraxane and Gemcitabine	Abraxane and Gemcitabine	Abraxane and Gemcitabine

Primary Outcome Measures

Name	Time	Method
overall response rate	8 weeks

Secondary Outcome Measures

Name	Time	Method
number of adverse events	6 months

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, China