A Phase II Study of 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