Back to resultsA Clinical Trial of Paclitaxel Loaded Polymeric Micelle in Patients With Taxane-Pretreated Recurrent Breast Cancer
Primary Purpose
Recurrent Breast Cancer
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Paclitaxel loaded Polymeric micelle
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Breast Cancer focused on measuring recurrent breast cancer, Genexol-PM
Eligibility Criteria
Inclusion Criteria:
- Women aged >=18 years
- WHO (ECOG) performance status 0-2
- Estimated life expectancy of >=3 months
- Have given written informed consent and are available for prolonged follow-up
Exclusion Criteria:
- Patients with previous chemotherapy for recurrent breast cancer
- Breast cancer recurrence within 12 months after taxane treatment
- Her-2/neu expression
- Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin.
- Brain metastasis
- uncontrolled infection, medically uncontrollable heart disease
- other serious medical illness or prior malignancies
- Pregnant or lactating women were excluded.
Sites / Locations
- Department of surgery, The Catholoic university of Korea, St. Mary's hospital.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Genexol-PM
Arm Description
All the patients are recurrent breast cancer after taxane treatment. Patients with a measurable lesion (at least 1 measurable lesion) Spiral CT : lesion ≥ 10mm (unidimension) X-ray, MRI, ultrasound : lesion ≥ 20 mm (unidimension)
Outcomes
Primary Outcome Measures
Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
Secondary Outcome Measures
Toxicity
Progression Free Survival
Tumor control rate
Full Information
NCT ID
NCT00912639
First Posted
May 31, 2009
Last Updated
June 15, 2009
Sponsor
Korean Breast Cancer Study Group
1. Study Identification
Unique Protocol Identification Number
NCT00912639
Brief Title
A Clinical Trial of Paclitaxel Loaded Polymeric Micelle in Patients With Taxane-Pretreated Recurrent Breast Cancer
Official Title
A Clinical Trial of Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) in Patients With Taxane-Pretreated Recurrent Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
May 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Korean Breast Cancer Study Group
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the response rate in patients with taxane-pretreated recurrent breast cancer receiving paclitaxel loaded polymeric micelle (Genexol-PM).
Detailed Description
Genexol-PM is a novel Cremophor EL-free polymeric micelle formulation of paclitaxel. This single arm, multicenter phase IV study was designed to evaluate the response rate, toxicity, progression free survival and tumor control rate of Genexol-PM in patients with Taxane-pretreated recurrence breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Breast Cancer
Keywords
recurrent breast cancer, Genexol-PM
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Genexol-PM
Arm Type
Experimental
Arm Description
All the patients are recurrent breast cancer after taxane treatment. Patients with a measurable lesion (at least 1 measurable lesion)
Spiral CT : lesion ≥ 10mm (unidimension)
X-ray, MRI, ultrasound : lesion ≥ 20 mm (unidimension)
Intervention Type
Drug
Intervention Name(s)
Paclitaxel loaded Polymeric micelle
Other Intervention Name(s)
Genexol-PM®
Intervention Description
Genexol-PM at a dose of 300mg/m2 was diluted in 500 ml of 5% dextrose solution or normal saline and infused i.v. for 3 h on day 1.Treatment was repeated every 3 weeks until either disease progression or intolerance. A minimum of 6 cycles was recommended.
Primary Outcome Measure Information:
Title
Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
1 year
Title
Progression Free Survival
Time Frame
1 year
Title
Tumor control rate
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women aged >=18 years
WHO (ECOG) performance status 0-2
Estimated life expectancy of >=3 months
Have given written informed consent and are available for prolonged follow-up
Exclusion Criteria:
Patients with previous chemotherapy for recurrent breast cancer
Breast cancer recurrence within 12 months after taxane treatment
Her-2/neu expression
Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin.
Brain metastasis
uncontrolled infection, medically uncontrollable heart disease
other serious medical illness or prior malignancies
Pregnant or lactating women were excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byung-Joo Song, MD.PhD.
Organizational Affiliation
The Catholoic university of Korea, St. Mary's hospital.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of surgery, The Catholoic university of Korea, St. Mary's hospital.
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial of Paclitaxel Loaded Polymeric Micelle in Patients With Taxane-Pretreated Recurrent Breast Cancer
We'll reach out to this number within 24 hrs