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NCT01784120 Clinical Trial

A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:
A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01784120
Other study ID # 2011-GIRBA-2566
Secondary ID
Status Recruiting
Phase Phase 2
First received January 30, 2013
Last updated February 9, 2016
Start date January 2011
Est. completion date December 2018

Study information
Verified date February 2016
Source Gachon University Gil Medical Center
Contact Hee Kyung Ahn
Phone +82-32-460-3229
Email hkahn@gilhospital.com
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 48
Est. completion date December 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Doxorubicin/Genexol-PM

Locations
Country Name City State
Korea, Republic of Gachon University Gil Medical Center Incheon

Sponsors (1)
Lead Sponsor Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Other overall survival one year Yes
Other progression-free-survival one year Yes
Primary response rate one year Yes
Secondary number of participants with adverse events one year Yes
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