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

This study is currently recruiting participants.
Verified October 2012 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Xichun Hu, Fudan University
ClinicalTrials.gov Identifier:
NCT01550848
First received: February 27, 2012
Last updated: October 5, 2012
Last verified: October 2012
History of Changes
  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: 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:

U.S. FDA Resources

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: 47
Study Start Date: January 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abraxane and Gemcitabine
Abraxane and Gemcitabine
 Drug: Abraxane and Gemcitabine

ABX 125 mg/m2，intravenous infusion，30min，day 1, 8, 15

GEM 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

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

Contacts
Contact: Biyun Wang, MD 13701748410 wangbiyun@msn.com

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

No publications provided

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: October 5, 2012
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on May 22, 2013