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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gachon University Gil Medical Center
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

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