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

September 8, 2015 updated by: Xichun Hu, Fudan University

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

The purpose of this study is to evaluate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Fudan University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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 Names:
  • Combined Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall response rate
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
number of adverse events
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Xichun Hu, MD;PhD, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

February 27, 2012

First Submitted That Met QC Criteria

March 7, 2012

First Posted (ESTIMATE)

March 12, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 9, 2015

Last Update Submitted That Met QC Criteria

September 8, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fudan BR2011-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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