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Trial Title:
A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer
NCT ID:
NCT01784120
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Doxorubicin
genexol-PM
Conditions: Keywords:
breast cancer
doxorubicin
genexol-PM
paclitaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Doxorubicin/Genexol-PM
Arm group label:
doxotubicin/Genexol-PM
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
Criteria for eligibility:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Gachon University Gil Medical Center
Address:
City:
Incheon
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hee Kyung Ahn
Phone:
+82-32-460-3229
Start date:
January 2011
Completion date:
December 2018
Lead sponsor:
Agency:
Gachon University Gil Medical Center
Agency class:
Other
Source:
Gachon University Gil Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01784120
