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A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer
Conditions
Metastatic Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
breast cancer, doxorubicin, genexol-PM, paclitaxel
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Doxorubicin/Genexol-PM
Type: Drug
Overall Status
Recruiting
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
1. Primary Purpose: response rate
2. Secondary purpose: toxicity, progression-free survival, overall survival
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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
- 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
Location
Gachon University Gil Medical Center
Incheon, Korea, Republic of
Status: Recruiting
Contact: Hee Kyung Ahn - +82-32-460-3229
Start Date
January 2011
Sponsors
Gachon University Gil Medical Center
Source
Gachon University Gil Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page