A Multicenter Phase II Study of Treatment With Hu3S193 in Women With Advanced Breast Cancer That Progressed After Hormonal Therapy
This is a national study, open label, single arm, phase II study which will be conducted in
seven centers in Brazil. The study will be coordinated by the INSTITUTO DO CÂNCER DO ESTADO
DE SÃO PAULO in collaboration with RECEPTA Biopharma. The study is funded by the CONSELHO
NACIONAL DE DESENVOLVIMENTO CIENTÍFICO E TECNOLÓGICO (CNPq). Before any procedure relating
to the study, patients must read and sign the informed consent (IC). The inclusion of
patients begin immediately after regulatory approval and is expected to end after reaching
the number of patients. The follow-up term will last at least 24 months for each patient
included, unless limited by death, loss to follow up or withdrawal of informed consent. A
total of 60 patients will be recruited in this study. The eligible patients must be 18 or
older, confirmed diagnosis of breast cancer with locally advanced or metastatic progression
after one or two lines of previous hormone treatment, confirmation of Lewis antigen
expression -as assessed by central laboratory, measurable or evaluable disease and adequate
organ function. Patients will receive weekly intravenous doses of the antibody Hu3S193 until
disease progression, unacceptable toxicity, withdrawal of consent or the investigator's
decision, whichever occurs first. The study's primary endpoint is the clinical benefit rate.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response, partial response or stable disease.
The primary efficacy analysis will be done through the clinical benefit rate, as defined by the proportion of patients achieving best response, complete response, partial response or stable disease for more than 24 weeks
more than 24 weeks
No
PAULO MG HOFF, MD Professor
Study Director
INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO
Brazil: Ethics Committee
52/2009
NCT01370239
July 2013
December 2015
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