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

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ClinicalTrials.gov Identifier: NCT01550848
Recruitment Status : Completed
First Posted : March 12, 2012
Last Update Posted : September 9, 2015
Sponsor:
Information provided by (Responsible Party):
Xichun Hu, 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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Abraxane and Gemcitabine Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Abraxane Combined With Gemcitabine in the Patients With Metastatic Breast Cancer
Study Start Date : January 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. overall response rate [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. number of adverse events [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550848


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

Responsible Party: Xichun Hu, Principal Investigator, Fudan University
ClinicalTrials.gov Identifier: NCT01550848     History of Changes
Other Study ID Numbers: Fudan BR2011-07
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Albumin-Bound Paclitaxel
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators