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

February 9, 2016 updated by: Eun Kyung Cho, Gachon University Gil Medical Center

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of
        • Recruiting
        • Gachon University Gil Medical Center
        • Contact:
          • Hee Kyung Ahn
          • Phone Number: +82-32-460-3229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: doxotubicin/Genexol-PM
Drug: Doxorubicin/Genexol-PM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
response rate
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
number of participants with adverse events
Time Frame: one year
one year

Other Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: one year
one year
progression-free-survival
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University Gil Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

January 30, 2013

First Submitted That Met QC Criteria

February 3, 2013

First Posted (Estimate)

February 5, 2013

Study Record Updates

Last Update Posted (Estimate)

February 10, 2016

Last Update Submitted That Met QC Criteria

February 9, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-GIRBA-2566

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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