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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Instituto do Cancer do Estado de São Paulo
Sponsor:
Collaborators:
Fundação Faculdade de Medicina
Recepta Biopharma
Information provided by (Responsible Party):
Paulo Marcelo Gehn Hoff, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier:
NCT01370239
First received: May 25, 2011
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Biological: Hu3S193
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Study of Treatment With Hu3S193 in Women With Advanced Breast Cancer That Progressed After Hormonal Therapy

Resource links provided by NLM:


Further study details as provided by Instituto do Cancer do Estado de São Paulo:

Primary Outcome Measures:
  • Complete response, partial response or stable disease. [ Time Frame: more than 24 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Response rate [ Time Frame: 24 weeks after patient discontinuation (at minimum) ] [ Designated as safety issue: No ]
    from inclusion until disease progression or death

  • Non progression rate [ Time Frame: 24 weeks after patient discontinuation (at minimum) ] [ Designated as safety issue: No ]
    From patient inclusion until disease progression or death - evaluated radiologically by CT

  • Overall survival [ Time Frame: 24 weeks after patient discontinuation (at minimum) or until death ] [ Designated as safety issue: No ]
    until death

  • Progression free survival [ Time Frame: until disease progression or 24 weeks after patient discontinuation (at minimum) ] [ Designated as safety issue: No ]
    Evaluated radiologically by CT

  • Assessment of any sign, symptom or undesirable medical condition that occurs after the first administration of the investigational agent [ Time Frame: Until disease progression or 30 days after patient discontinuation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: November 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hu3S193
Single arm
Biological: Hu3S193
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.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370239

Contacts
Contact: PAULO MG HOFF, MD, Lead Investigator 55-11-38932619 humanah@icesp.org.br
Contact: ROBERTO J ARAI, PHD, Manager 55-11-38932619 humanah@icesp.org.br

Locations
Brazil
Universidade Federal Do Ceará Recruiting
Fortaleza, Ceará, Brazil
Contact: MARIA ROCHA       teresarocha3@hotmail.com   
Contact: FABIA LIMA       fabiaufc@hotmail.com   
Principal Investigator: MANOEL OM FILHO, MD         
PONTIFíCIA UNIVERSIDADE CATÓLICA DO RIO GRANDE DO SUL Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil
Contact: PRISCILLA ALMEIDA       oncopucrs@yahoo.com.br   
Contact: TANIA MIELKE       oncopucrs@yahoo.com.br   
Principal Investigator: LUCIANA S VIOLA, MD         
Hospital Do Câncer de Barretos Recruiting
Barretos, São Paulo, Brazil
Contact: CAMILA ALFANO       camila.pesquisaclinica@hcancerbarretos.com.br   
Contact: LETICIA SILVA       leticia.pesquisaclinica@hcancerbarretos.com.br   
Principal Investigator: SERGIO V SERRANO, MD         
Universidade Federal de Goias Recruiting
Goias, Brazil
Contact: DANIELLE RORIZ       daniellesilvaroriz@gmail.com   
Contact: DANIELLE RODRIGUEZ       daniellepsinetto@yahoo.com.br   
Principal Investigator: RUFFO FREITAS, MD PHD         
Instituto Nacional Do Câncer Recruiting
Rio de Janeiro, Brazil
Contact: ROBERTO SARMENTO       rsamento@inca.gov.br   
Contact: JOSÉ CARMO       jalaxandre@inca.gov.br   
Principal Investigator: SUZANNE CV COSTA, MD         
Hospital Sirio Libanes Recruiting
Sao Paulo, Brazil
Contact: NATALIA DELBIAGGI       natalia.delbiagi@hsl.org.br   
Principal Investigator: LAURA TESTA, MD         
Instituto Do Câncer Do Estado de São Paulo Recruiting
Sao Paulo, Brazil, 01246-000
Contact: MARIANA FIUZA    55-11-389332691    mariana.fiuza@icesp.org.br   
Contact: ELAINE S LONGO, COORDINATOR    55-11-38932646    elaine.longo@icesp.org.br   
Principal Investigator: MAX S MANO, MD PHD         
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
Fundação Faculdade de Medicina
Recepta Biopharma
Investigators
Study Director: PAULO MG HOFF, MD Professor INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO
Study Director: SERGIO V SERRANO, MD HOSPITAL DO CÂNCER DE BARRETOS
  More Information

Additional Information:
No publications provided

Responsible Party: Paulo Marcelo Gehn Hoff, FACP MD PhD, Full Professor, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT01370239     History of Changes
Other Study ID Numbers: 52/2009
Study First Received: May 25, 2011
Last Updated: March 13, 2014
Health Authority: Brazil: Agência Nacional de Vigilância Sanitária - ANVISA

Keywords provided by Instituto do Cancer do Estado de São Paulo:
monoclonal antibody
Lewis
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014