A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer
1 other identifier
interventional
48
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2011
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 30, 2013
CompletedFirst Posted
Study publicly available on registry
February 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 10, 2016
February 1, 2016
7 years
January 30, 2013
February 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
response rate
one year
Secondary Outcomes (1)
number of participants with adverse events
one year
Other Outcomes (2)
overall survival
one year
progression-free-survival
one year
Study Arms (1)
doxotubicin/Genexol-PM
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gachon University Gil Medical Center
Incheon, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 30, 2013
First Posted
February 5, 2013
Study Start
January 1, 2011
Primary Completion
January 1, 2018
Study Completion
December 1, 2018
Last Updated
February 10, 2016
Record last verified: 2016-02