Back to resultsA Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer
Primary Purpose
Metastatic Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Doxorubicin/Genexol-PM
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring breast cancer, doxorubicin, genexol-PM, paclitaxel
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
Sites / Locations
- Gachon University Gil Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
doxotubicin/Genexol-PM
Arm Description
Outcomes
Primary Outcome Measures
response rate
Secondary Outcome Measures
number of participants with adverse events
Full Information
NCT ID
NCT01784120
First Posted
January 30, 2013
Last Updated
February 9, 2016
Sponsor
Gachon University Gil Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01784120
Brief Title
A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer
Official Title
A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center
4. Oversight
5. Study Description
Brief Summary
To evaluate efficacy and toxicity of doxorubicin/Genexol-PM in metastatic breast cancer
Primary Purpose: response rate
Secondary purpose: toxicity, progression-free survival, overall survival
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
breast cancer, doxorubicin, genexol-PM, paclitaxel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
doxotubicin/Genexol-PM
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Doxorubicin/Genexol-PM
Primary Outcome Measure Information:
Title
response rate
Time Frame
one year
Secondary Outcome Measure Information:
Title
number of participants with adverse events
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
overall survival
Time Frame
one year
Title
progression-free-survival
Time Frame
one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee Kyung Ahn
Phone
+82-32-460-3229
Email
hkahn@gilhospital.com
Facility Information:
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee Kyung Ahn
Phone
+82-32-460-3229
12. IPD Sharing Statement
Learn more about this trial
A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer
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