Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Patients will receive weekly intravenous doses of 20 mg/m2 of the antibody Hu3S193. The infusion will take 60 ± 10 minutes. The antibody should be diluted in 500 mL of normal saline.

Hu3S193

PAULO MG HOFF, MD Professor

SERGIO V SERRANO, MD

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.

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.

HumanaH - Hu3s193 in the Treatment of Advanced Breast Cancer After Hormonal Therapy

A Multicenter Phase II Study of Treatment With Hu3S193 in Women With Advanced Breast Cancer That Progressed After Hormonal Therapy

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

from inclusion until disease progression or death

From patient inclusion until disease progression or death - evaluated radiologically by CT

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
HumanaH - Hu3s193 in the Treatment of Advanced Breast Cancer After Hormonal Therapy	NCT01370239	Breast Cancer	Hu3S193	18 Years -	Instituto do Cancer do Estado de São Paulo
HumanaH - Hu3s193 in the Treatment of Advanced Breast Cancer After Hormonal Therapy	NCT01370239	Breast Cancer	Hu3S193	18 Years -	Instituto do Cancer do Estado de São Paulo
HumanaH - Hu3s193 in the Treatment of Advanced Breast Cancer After Hormonal Therapy	NCT01370239	Breast Cancer	Hu3S193	18 Years -	Instituto do Cancer do Estado de São Paulo

Spots Global Cancer Trial Database for lewis

Every month we try and update this database with for lewis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lewis

Every month we try and update this database with for lewis cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lewis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.