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

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ClinicalTrials.gov Identifier: NCT01784120
Recruitment Status : Unknown
Verified February 2016 by Eun Kyung Cho, Gachon University Gil Medical Center.
Recruitment status was:  Recruiting
First Posted : February 5, 2013
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
Eun Kyung Cho, Gachon University Gil Medical Center

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

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Doxorubicin/Genexol-PM Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer
Study Start Date : January 2011
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: doxotubicin/Genexol-PM Drug: Doxorubicin/Genexol-PM



Primary Outcome Measures :
  1. response rate [ Time Frame: one year ]

Secondary Outcome Measures :
  1. number of participants with adverse events [ Time Frame: one year ]

Other Outcome Measures:
  1. overall survival [ Time Frame: one year ]
  2. progression-free-survival [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784120


Contacts
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Contact: Hee Kyung Ahn +82-32-460-3229 hkahn@gilhospital.com

Locations
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Korea, Republic of
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of
Contact: Hee Kyung Ahn    +82-32-460-3229      
Sponsors and Collaborators
Gachon University Gil Medical Center

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Responsible Party: Eun Kyung Cho, Professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01784120     History of Changes
Other Study ID Numbers: 2011-GIRBA-2566
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016
Keywords provided by Eun Kyung Cho, Gachon University Gil Medical Center:
breast cancer
doxorubicin
genexol-PM
paclitaxel
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action