Spots Global Cancer Trial Database for HumanaH - Hu3s193 in the Treatment of Advanced Breast Cancer After Hormonal Therapy
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Trial Identification
Brief Title: HumanaH - Hu3s193 in the Treatment of Advanced Breast Cancer After Hormonal Therapy
Official Title: A Multicenter Phase II Study of Treatment With Hu3S193 in Women With Advanced Breast Cancer That Progressed After Hormonal Therapy
Study ID: NCT01370239
Conditions
Interventions
Study Description
Brief Summary: The humanized monoclonal antibody against Lewis Y antigen (Hu3S193) has been demonstrated to be safe in previous studies and has also been indicated as potential intervention in breast cancer. The study of this new agent in advanced breast cancer may contribute to the development of new strategies for patients that progressed after hormonal treatment.
Detailed Description: 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 CĂNCER DO ESTADO DE SĂO PAULO in collaboration with RECEPTA Biopharma. The study is funded by the CONSELHO NACIONAL DE DESENVOLVIMENTO CIENTĂFICO E TECNOLĂGICO (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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Universidade Federal Do CearĂĄ, Fortaleza, CearĂĄ, Brazil
PONTIFĂCIA UNIVERSIDADE CATĂLICA DO RIO GRANDE DO SUL, Porto Alegre, RIO Grande DO SUL, Brazil
Hospital Do Câncer de Barretos, Barretos, SĂO Paulo, Brazil
Universidade Federal de Goias, Goias, , Brazil
Instituto Nacional Do Câncer, Rio de Janeiro, , Brazil
Instituto Do Câncer Do Estado de São Paulo, Sao Paulo, , Brazil
Hospital Sirio Libanes, Sao Paulo, , Brazil
Contact Details
Name: PAULO MG HOFF, MD Professor
Affiliation: INSTITUTO DO CĂNCER DO ESTADO DE SĂO PAULO
Role: STUDY_DIRECTOR
Name: SERGIO V SERRANO, MD
Affiliation: HOSPITAL DO CĂNCER DE BARRETOS
Role: STUDY_DIRECTOR
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