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

Phase 2
18 Years
70 Years
Open (Enrolling)
Metastatic Breast Cancer

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Trial Information

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

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

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Xichun Hu, MD;PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Ethics Committee

Study ID:

Fudan BR2011-07



Start Date:

January 2012

Completion Date:

June 2015

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms