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

Fudan University

Status and phase

Completed

Phase 2

Conditions

Metastatic Breast Cancer

Treatments

Drug: Abraxane and Gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT01550848

Fudan BR2011-07

Details and patient eligibility

About

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

Full description

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

Enrollment

84 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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