A Clinical Trial of Paclitaxel Loaded Polymeric Micelle in Patients With Taxane-Pretreated Recurrent Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Clinical Trial of Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) in Patients With Taxane-Pretreated Recurrent Breast Cancer

Conditions
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Recurrent Breast Cancer

Intervention / Treatment
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* Drug: Paclitaxel loaded Polymeric micelle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genexol-PM<br>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) | Drug: Paclitaxel loaded Polymeric micelle<br>* 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.<br>* Other names: Genexol-PM®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  | 1 year | 
| Progression Free Survival |  | 1 year | 
| Tumor control rate |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent breast cancer, Genexol-PM