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

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