A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer
Phase 2
- Conditions
- Metastatic Breast Cancer
- Interventions
- Drug: Doxorubicin/Genexol-PM
- Registration Number
- NCT01784120
- Lead Sponsor
- Gachon University Gil Medical Center
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 48
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description doxotubicin/Genexol-PM Doxorubicin/Genexol-PM -
- Primary Outcome Measures
Name Time Method response rate one year
- Secondary Outcome Measures
Name Time Method number of participants with adverse events one year
Trial Locations
- Locations (1)
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of