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

NCT01370239 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2019-10-11

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Fundação Faculdade de Medicina

    collaborator OTHER

  • Recepta Biopharma

    collaborator INDUSTRY

  • Instituto do Cancer do Estado de São Paulo

    lead OTHER

Principal Investigators

  • PAULO MG HOFF, MD Professor · INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO

  • SERGIO V SERRANO, MD · HOSPITAL DO CÂNCER DE BARRETOS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-10-31
Completion
2018-05-25

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01370239 on ClinicalTrials.gov