Liposomal Doxorubicin (Lipo-Dox) in Patients With Brain Metastasis From Breast Cancer

Study Overview
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Brief Summary
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Primary objective: To determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis Secondary objectives: To determine the overall objective response rate (ORR) To determine the progression free survival, and duration of objective response To evaluate the overall survival (OS) To assess the safety profiles

Detailed Description
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This is an open-label, non-comparative phase II clinical trial. Approximately thirty-three patients will be enrolled in order to obtain twenty-nine evaluable subjects who received two cycles of study treatment in Simon's 2-stage optimal design. Duration of subject involvement: Study treatment should be administered up to disease progression, intolerable toxicity, or consent withdrawal. Recruitment period: 10 months

Official Title
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A Phase II Study of Liposomal Doxorubicin (Lipo-Dox) in Patients With Brain Metastasis From Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Liposomal Doxorubicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically proved breast cancer Relapse/recurrent brain metastasis progression after brain radiotherapy Presence of brain measurable disease which is defined as at least one brain lesion that can be measured in at least 1 dimension as ³ 20 mm with magnetic resonance image (MRI) Prior chemotherapy or hormone therapy for metastatic breast cancer is allowed Performance status of ECOG 0, 1, 2 With normal left ventricular ejection fraction and normal ventricular contractility Age 21 years or older Life expectancy equal or longer than 3 months Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Prior anthracycline-containing chemotherapy with cumulative dose exceed 400mg/m2 doxorubicin or 750 mg/m2 Epirubicin Surgery , radiotherapy, hormonal therapy or chemotherapy within 4 weeks prior to entering the study Prior liposomal doxorubicin treatment Concurrent chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period Other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study Brain metastases defined as meninges metastases Presence of serious concomitant illness which might be aggravated by study medication: Uncontrolled infection (active serious infections that are not controlled by antibiotics) Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study. History of ventricular arrhythmia or congestive heart failure. Presence of abnormal left ventricular ejection fraction Hematopoietic function as defined below: Hemoglobin<10g/dl ANC< 1,500/uL Platelets<100,000/uL Organ function as defined below: Total bilirubin >1.5 × ULN ALT / AST>3 × ULN (>5.0 x ULN if hepatic metastasis) Creatinine >1.5 × ULN Mental status is not fit for clinical trial Pregnant or breast feeding women, or women of child-bearing potential unless using a reliable and appropriate contraceptive method

Ages Eligible for Study
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Minimum Age: 21 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Liposomal Doxorubicin|40mg/m2 over 1 hour infusion for 21 days|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the overall objective response rate |  | 3 years | 
| To determine the progression free survival, and duration of objective response |  | 3 years | 
| To evaluate the overall survival |  | 3 years | 
| To assess the safety profiles |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, brain metastatsis, Lipo-Dox