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

Overview[ - collapse ][ - ]

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.
ConditionMetastatic Breast Cancer
InterventionDrug: Abraxane and Gemcitabine
PhasePhase 2
SponsorFudan University
Responsible PartyFudan University
ClinicalTrials.gov IdentifierNCT01550848
First ReceivedFebruary 27, 2012
Last UpdatedDecember 1, 2013
Last verifiedDecember 2013

Tracking Information[ + expand ][ + ]

First Received DateFebruary 27, 2012
Last Updated DateDecember 1, 2013
Start DateJanuary 2012
Estimated Primary Completion DateJune 2015
Current Primary Outcome Measuresoverall response rate [Time Frame: 8 weeks] [Designated as safety issue: No]
Current Secondary Outcome Measuresnumber of adverse events [Time Frame: 6 months] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitleA Phase II Study of Abraxane Gemcitabine Combination in Patients With Metastatic Breast Cancer
Official TitleA Phase II Study of Abraxane Combined With Gemcitabine in the Patients With Metastatic Breast Cancer
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.
Detailed Description
This study is to investigate the efficacy and toxicity of Abraxane combined with Gemcitabine
in the patients with metastatic breast cancer.
Study TypeInterventional
Study PhasePhase 2
Study DesignEndpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionMetastatic Breast Cancer
InterventionDrug: 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 Names:
Combined Chemotherapy
Study Arm (s)Experimental: Abraxane and Gemcitabine
Abraxane and Gemcitabine

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment84
Estimated Completion DateJune 2015
Estimated Primary Completion DateDecember 2014
Eligibility 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
GenderFemale
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: Biyun Wang, MD
13701748410
wangbiyun@msn.com
Location CountriesChina

Administrative Information[ + expand ][ + ]

NCT Number NCT01550848
Other Study ID NumbersFudan BR2011-07
Has Data Monitoring CommitteeNo
Information Provided ByFudan University
Study SponsorFudan University
CollaboratorsNot Provided
Investigators Principal Investigator: Xichun Hu, MD;PhD Fudan University
Verification DateDecember 2013

Locations[ + expand ][ + ]

Fudan University Cancer Hospital
Shanghai, China, 200032
Principal Investigator: Xichun Hu, MD;PhD
Recruiting