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Clinical Trials/NCT01550848
NCT01550848CompletedPhase 2

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

Fudan University1 site in 1 country84 target enrollmentStarted: January 2012Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
84
Locations
1
Primary Endpoint
overall response rate

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

Abraxane and Gemcitabine

Experimental

Abraxane and Gemcitabine

Intervention: Abraxane and Gemcitabine (Drug)

Outcomes

Primary Outcomes

overall response rate

Time Frame: 8 weeks

Secondary Outcomes

  • number of adverse events(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xichun Hu

Principal Investigator

Fudan University

Study Sites (1)

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