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Safety and Efficacy Study of the Trifunctional Antibody Ertumaxomab to Treat Patients With Advanced or Metastatic Breast Cancer

2014-08-27 03:43:30 | BioPortfolio

Summary

The purpose of this study is to determine the safety and efficacy of the investigational trifunctional anti-Her-2/neu x anti-CD3 antibody ertumaxomab as treatment for hormone therapy refractory Her-2/neu 1+ or 2+ expressing advanced or metastatic breast cancer

Description

A multi-centre, phase II study of ertumaxomab in metastatic breast cancer patients who became progressive after hormonal therapy. Each eligible patient will receive three ascending doses of ertumaxomab, administered intravenously. Ertumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 7 days. Each patient will participate in this study for up to 7 months (includes the up to 21 days screening period, 14 days treatment period, and up to 180 days/6 months follow-up), with 3-monthly post-study follow-up until the patient becomes progressive.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Neoplasms

Intervention

ertumaxomab

Location

Study site
.
Belgium
1000

Status

Terminated

Source

Fresenius Biotech GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:43:30-0400

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Medical and Biotech [MESH] Definitions

Breast neoplasms that do not express ESTROGEN RECEPTORS; PROGESTERONE RECEPTORS; and do not overexpress the NEU RECEPTOR/HER-2 PROTO-ONCOGENE PROTEIN.

Any neoplasms of the male breast. These occur infrequently in males in developed countries, the incidence being about 1% of that in females.

Neoplasms, usually carcinoma, located within the center of an organ or within small lobes, and in the case of the breast, intraductally. The emphasis of the name is on the location of the neoplastic tissue rather than on its histological type. Most cancers of this type are located in the breast.

Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.

Tumors or cancer of the human BREAST.

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