A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer

A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer

To evaluate efficacy and toxicity of doxorubicin/Genexol-PM in metastatic breast cancer

1. Primary Purpose: response rate
2. Secondary purpose: toxicity, progression-free survival, overall survival

Inclusion Criteria:

• 18 years of age or older adult women
• Instrumentation measurable lesions with histologically confirmed advanced (recurrent or metastatic) breast cancer
• ECOG 0-2
• Advanced breast cancer in the past, patients who did not receive chemotherapy
• Recurrence if adjuvant chemotherapy and adjuvant chemotherapy in the past for more than 6 months until the patient
• life expectancy more than 3 months
• Agree in writing before the party to participate in a clinical trial to patients

Exclusion Criteria:

• immunohistochemical staining 3 + or FISH positive anti-HER 2 therapy patients
• Severe infections requiring antibiotic therapy
• Clinically significant heart disease
• Pregnant or lactating woman
• Uncontrolled symptoms in the central nervous system (CNS) metastases
• Patients diagnosed with malignant tumors of other organs