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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01550848
First Posted: March 12, 2012
Last Update Posted: September 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Xichun Hu, Fudan University
  Purpose
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: 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

Resource links provided by NLM:


Further study details as provided by Xichun Hu, Fudan University:

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

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

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.
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Responsible Party: Xichun Hu, Principal Investigator, Fudan University
ClinicalTrials.gov Identifier: NCT01550848     History of Changes
Other Study ID Numbers: Fudan BR2011-07
First Submitted: February 27, 2012
First Posted: March 12, 2012
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


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