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

This study has been completed.
Information provided by (Responsible Party):
Xichun Hu, Fudan University
ClinicalTrials.gov Identifier:
First received: February 27, 2012
Last updated: September 8, 2015
Last verified: September 2015
The purpose of this study is to evaluate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.

Condition Intervention Phase
Metastatic Breast Cancer
Drug: Abraxane and Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Abraxane Combined With Gemcitabine in the Patients With Metastatic Breast Cancer

Resource links provided by NLM:

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • overall response rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 84
Study Start Date: January 2012
Study Completion Date: June 2015
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abraxane and Gemcitabine
Abraxane and Gemcitabine
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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01550848

Fudan University Cancer Hospital
Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Principal Investigator: Xichun Hu, MD;PhD Fudan University
  More Information

Responsible Party: Xichun Hu, Principal Investigator, Fudan University
ClinicalTrials.gov Identifier: NCT01550848     History of Changes
Other Study ID Numbers: Fudan BR2011-07 
Study First Received: February 27, 2012
Last Updated: September 8, 2015
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on April 27, 2016