Metastatic Breast Cancer
Conditions
Keywords
breast cancer, doxorubicin, genexol-PM, paclitaxel
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
Interventions
DRUGDoxorubicin/Genexol-PM
Sponsors
Gachon University Gil Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | one year |
Secondary
| Measure | Time frame |
|---|---|
| number of participants with adverse events | one year |
Other
| Measure | Time frame |
|---|---|
| overall survival | one year |
| progression-free-survival | one year |
Countries
South Korea
Contacts
Primary ContactHee Kyung Ahn
Outcome results
None listed