Status and phase
Conditions
Treatments
About
Primary objective:
To determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis
Secondary objectives:
Full description
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
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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:
Presence of abnormal left ventricular ejection fraction
Hematopoietic function as defined below:
Organ function as defined below:
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
Primary purpose
Allocation
Interventional model
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Data sourced from clinicaltrials.gov
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