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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xichun Hu, Fudan University
ClinicalTrials.gov Identifier:
NCT01550848
First received: February 27, 2012
Last updated: September 8, 2015
Last verified: September 2015

February 27, 2012
September 8, 2015
January 2012
July 2014   (final data collection date for primary outcome measure)
overall response rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01550848 on ClinicalTrials.gov Archive Site
number of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Phase II Study of Abraxane Gemcitabine Combination in Patients With Metastatic Breast Cancer
A Phase II Study of Abraxane Combined With Gemcitabine in the Patients With Metastatic Breast Cancer
The purpose of this study is to evaluate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.
This study is to investigate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
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

Other Name: Combined Chemotherapy
Experimental: Abraxane and Gemcitabine
Abraxane and Gemcitabine
Intervention: Drug: Abraxane and Gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
June 2015
July 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01550848
Fudan BR2011-07
No
Not Provided
Not Provided
Xichun Hu, Fudan University
Fudan University
Not Provided
Principal Investigator: Xichun Hu, MD;PhD Fudan University
Fudan University
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP