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

Phase 2
21 Years
Not Enrolling
Breast Cancer

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Trial Information

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

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

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

- 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

- 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

- Uncontrolled infection (active serious infections that are not controlled by

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Alex Chang

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins SIngapore International Medical Center


Singapore: Health Sciences Authority

Study ID:

JS 0553



Start Date:

September 2005

Completion Date:

July 2009

Related Keywords:

  • Breast Cancer
  • breast cancer
  • brain metastatsis
  • Lipo-Dox
  • Breast Neoplasms
  • Neoplasm Metastasis