Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer After Progression on Trastuzumab Therapy
Stopped early · Phase 2
Conditions studied: Metastatic Breast Cancer, Advanced Breast Cancer
In brief
This study has the purpose to demonstrate clinical efficacy of the investigational new drug ertumaxomab in patients with human epidermal growth factor receptor-2 (HER-2/neu) overexpressing (3+ or 2+ with a positive Fluorescence In Situ Hybridization (FISH) test result) metastatic breast cancer progressing after trastuzumab treatment. Ertumaxomab is a trifunctional bispecific antibody targeting Her-2/neu on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory immune effector cells (e.g. macrophages, dendritic cells \[DCs\] and natural killer \[NK\] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these immune cells, which can trigger a complex anti-tumor immune response.
Key facts
- Study ID
- NCT00522457
- Run by
- Neovii Biotech
- People needed
- 19
- Starts
- 2008-01-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2011-04-29
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
Where it is running
- Study site — Minneapolis, Minnesota, United States
- Study site — Lebanon, New Hampshire, United States
- Study site — New York, New York, United States
- Study site — Ottawa, Ontario, Canada
- Study site — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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