Breast Cancer Clinical Trial
Official title:
A Multicenter Phase II Study of Treatment With Hu3S193 in Women With Advanced Breast Cancer That Progressed After Hormonal Therapy
NCT number | NCT01370239 |
Other study ID # | 52/2009 |
Secondary ID | |
Status | Terminated |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | November 2013 |
Est. completion date | May 25, 2018 |
Verified date | October 2019 |
Source | Instituto do Cancer do Estado de São Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 23 |
Est. completion date | May 25, 2018 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of breast cancer with locally advanced or metastatic (stages IIIB, IIIC or IV according to TNM classification), confirmed histologically with no intention to curative treatment by radiotherapy or surgery; - Clinical or radiological progression after one or two lines of previous hormone treatment, including adjuvant treatment; - Positive for ER and / or PR expression documented by IHC; - Confirmed expression of Lewis Y antigen by IHC; - Presenting the performance status of 0 or 1 according to Eastern Cooperative Oncology Group (ECOG); - Have a measurable or evaluable disease by Response of Evaluation Criteria in Solid Tumors (RECIST); - Adequate organ function, assessed by laboratory tests obtained at least 2 weeks before the first day of treatment and within the following parameters: absolute neutrophil count = 1.5 x 109 / L; platelet count = 100 x 109 / L; serum bilirubin = 2.0 mg / dL; AST/ALT = 2.5 x upper limit of normal; serum creatinine = 2.0 mg / dL; - Expected survival > 12 weeks; - In patients with childbearing potential: Negative pregnancy confirmed by test done 21 days before the date of study treatment initiation; - Willingness and ability to comply with the protocol for the duration of the study. Exclusion Criteria: - Patients subjected previously to more than two lines of hormonal therapy, including adjuvant treatment; - Presenting the amplification or overexpression of HER-2; - Systemic corticosteroids or immunosuppressive agents used concomitantly with the study or have used systemic corticosteroids or immunosuppressants in the last 14 days before the first dose of the investigational drug; - Visceral metastatic disease with life-threatening (as defined by extensive liver involvement), or symptomatic pulmonary lymphangitic carcinomatosis or any degree of cerebral or leptomeningeal involvement; - Previous or current history of clinically significant cardiac disease (class III or IV according to New York Heart Association); - Clinically significant arrhythmia; - History of myocardial infarction within the last 6 months; - Previous or current history of other severe diseases (eg, severe ascites requiring repeated drainage, active infections requiring antibiotics, bleeding, inflammatory bowel disease or chronic diseases that may interfere with obtaining accurate results of the study); - Previous chemotherapy for metastatic disease (adjuvant chemotherapy is acceptable, if more than four weeks between its completion and inclusion in the study; - Radiotherapy within 4 weeks before inclusion in the study or with no recovery from the toxic effects of radiotherapy when done up to 6 weeks before inclusion in the study, except for palliative radiotherapy for bone metastases involving <25 % bone marrow; - Treatment with biological agents, immunotherapy or surgery within 4 weeks before inclusion in the study or with no recovery from the toxic effects of these treatments when made until six weeks prior to study entry (prior treatment with bisphosphonates is allowed, it can be continued after inclusion in the study); - Any investigational agent treatment within 12 months prior to study entry, unless the investigator considers that the participation in the study may benefit the patient; - Previous or current history of another type of tumor, excluding skin cancer, melanoma, in situ cervix carcinoma or in situ ductal carcinoma or lobular breast if properly treated; - Uncontrolled hypercalcemia (defined as total calcium> 11.5 mg / dL) |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Do Câncer de Barretos | Barretos | SÃO Paulo |
Brazil | Universidade Federal Do Ceará | Fortaleza | Ceará |
Brazil | Universidade Federal de Goias | Goias | |
Brazil | PONTIFíCIA UNIVERSIDADE CATÓLICA DO RIO GRANDE DO SUL | Porto Alegre | RIO Grande DO SUL |
Brazil | Instituto Nacional Do Câncer | Rio de Janeiro | |
Brazil | Hospital Sirio Libanes | Sao Paulo | |
Brazil | Instituto Do Câncer Do Estado de São Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Instituto do Cancer do Estado de São Paulo | Fundação Faculdade de Medicina, Recepta Biopharma |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Response rate | from inclusion until disease progression or death | 24 weeks after patient discontinuation (at minimum) | |
Secondary | Non progression rate | From patient inclusion until disease progression or death - evaluated radiologically by CT | 24 weeks after patient discontinuation (at minimum) | |
Secondary | Overall survival | until death | 24 weeks after patient discontinuation (at minimum) or until death | |
Secondary | Progression free survival | Evaluated radiologically by CT | until disease progression or 24 weeks after patient discontinuation (at minimum) | |
Secondary | Assessment of any sign, symptom or undesirable medical condition that occurs after the first administration of the investigational agent | Until disease progression or 30 days after patient discontinuation |
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