A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer
Overview[ - collapse ][ - ]
| Purpose | 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 |
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| Condition | Metastatic Breast Cancer |
| Intervention | Drug: Doxorubicin/Genexol-PM |
| Phase | Phase 2 |
| Sponsor | Gachon University Gil Medical Center |
| Responsible Party | Gachon University Gil Medical Center |
| ClinicalTrials.gov Identifier | NCT01784120 |
| First Received | January 30, 2013 |
| Last Updated | August 19, 2013 |
| Last verified | August 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 30, 2013 |
|---|---|
| Last Updated Date | August 19, 2013 |
| Start Date | January 2011 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | response rate [Time Frame: one year] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures | number of participants with adverse events [Time Frame: one year] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer |
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| Official Title | A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer |
| 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 Provided |
| 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 |
| Condition | Metastatic Breast Cancer |
| Intervention | Drug: Doxorubicin/Genexol-PM |
| Study Arm (s) | Experimental: doxotubicin/Genexol-PM |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 48 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | January 2014 |
| 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 |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Hee Kyung Ahn +82-32-460-3229 hkahn@gilhospital.com |
| Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01784120 |
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| Other Study ID Numbers | 2011-GIRBA-2566 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Gachon University Gil Medical Center |
| Study Sponsor | Gachon University Gil Medical Center |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | August 2013 |
Locations[ + expand ][ + ]
| Gachon University Gil Medical Center | Incheon, Korea, Republic of Contact: Hee Kyung Ahn | +82-32-460-3229Recruiting |
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