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Old 12-30-2008, 01:44 PM   #1
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Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast


Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer After Progression on Trastuzumab Therapy
This study is currently recruiting participants.
Verified by Fresenius Biotech GmbH, March 2008
Sponsors and Collaborators: Fresenius Biotech GmbH
Fresenius Biotech North America
Information provided by: Fresenius Biotech GmbH ClinicalTrials.gov Identifier: NCT00522457
Purpose This study has the purpose to demonstrate clinical efficacy of the investigational new drug ertumaxomab in patients with HER 2/neu overexpressing (3+ or 2+ with a positive 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.

Condition Intervention Phase Metastatic Breast Cancer
Advanced Breast Cancer
Drug: ertumaxomab
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Immunoglobulins Globulin, Immune Visilizumab Trastuzumab Ertumaxomab
U.S. FDA Resources
Study Type:
Study Design:
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:
Phase II Study Of The Trifunctional Bispecific Anti-HER-2/Neu x Anti-CD3 Antibody Ertumaxomab In Patients With HER-2/Neu Overexpressing (3+ Or 2+/FISH+) Metastatic Breast Cancer Progressing After Trastuzumab Treatment

Further study details as provided by Fresenius Biotech GmbH:

Primary Outcome Measures:
  • Clinical efficacy measured by objective response rate (best response during the course of the study)

Secondary Outcome Measures:
  • Duration of response
  • Clinical benefit rate
  • Safety

Estimated Enrollment:
Study Start Date:
August 2007

Detailed Description: This study is an open-label, non-randomized, uncontrolled, two-stage phase II study evaluating the efficacy and safety of ertumaxomab. Ertumaxomab will be administered three times at 7 day intervals by constant rate 3 hour intravenous (i.v.) infusions according to the following dose schedule: 10 g (day 0); 100 g (day 7 1 day) and 100 g (day 14 1 day) (flat doses).

Eligibility Ages Eligible for Study:
18 Years and older
Genders Eligible for Study:
Accepts Healthy Volunteers:
Key Inclusion Criteria:
  • Women ≥ 18 years, Negative pregnancy test at screening and life expectancy of at least 3 months
  • metastatic (stage IV) and not curable adenocarcinoma of the breast
  • Measurable disease, defined as at least one lesion that is measurable in one dimension (RECIST)
  • HER-2 overexpression 3+ or 2+ FISH positive
  • Patients must have received one prior therapy with trastuzumab as last treatment before entry into the study. If trastuzumab was given as single agent treatment, patients must have received prior chemotherapy for metastatic disease
  • Trastuzumab has been discontinued before study entry
  • disease had progressed during or after trastuzumab therapy
  • ECOG performance score of ≤ 2
  • Adequate hematological, liver and kidney function
Key Exclusion Criteria:
  • Women who are pregnant or breast feeding
  • Any history or symptoms indicative of brain or central nervous system metastases
  • Prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
  • Human anti-murine antibody positive or hypersensitivity to murine proteins and any other component of the study drug
  • Known autoimmune diseases, HIV, hepatitis B or C infection as well as other acute or chronic infection or other concurrent non-malignant co-morbidities that are uncontrolled
  • Any concurrent chemotherapy, hormonal therapy, immunotherapy or corticoid therapy
  • Concurrent antibiotic treatment
  • Any concurrent investigational treatment for metastatic disease
Cardiovascular exclusion criteria:
  • Unstable or uncontrolled pectorial angina
  • Myocardial infarction during the last 6 months
  • Valvular heart disease that requires treatment
  • Cardiomyopathy (congestive, hypertrophic or restrictive)
  • Acute myocarditis
  • Congestive heart failure (CHF): dyspnea, clinically or radiologically diagnosed
  • Left ventricular ejection fraction (LVEF)outside institution's normal range based on echocardiography at rest
  • Left ventricular diameter > 56 mm based on M-mode echocardiography at rest
  • Arrhythmias that require treatment (atrioventricular block II/III degree, atrial fibrillation, ventricular tachycardia)
  • Poorly or uncontrolled hypertension, asthma, seizures, allergies, pulmonary dysfunction

Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522457

Contact: Barbara Kolb 1-866-580-7270 clinicaltrials@fresenius-biotech.com


United States, Minnesota

Recruiting Minneapolis, Minnesota, United States Contact: Barbara Kolb 1-866-580-7270 clinicaltrials@fresenius-biotech.com United States, New Hampshire

Recruiting Lebanon, New Hampshire, United States Contact: Barbara Kolb 1-866-580-7270 clinicaltrials@fresenius-biotech.com United States, New York

Recruiting New York, New York, United States Contact: Barbara Kolb 1-866-580-7270 clinicaltrials@fresenius-biotech.com United States, South Carolina

Recruiting Spartanburg, South Carolina, United States Contact: Barbara Kolb 1-866-580-7270 clinicaltrials@fresenius-biotech.com Canada, Ontario

Recruiting Ottawa, Ontario, Canada Contact: Barbara Kolb 1-866-580-7270 clinicaltrials@fresenius-biotech.com

Sponsors and Collaborators
Fresenius Biotech GmbH
Fresenius Biotech North America

Principal Investigator: Gary Schwartz, MD Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center; Lebanon, NH

Mom's treatment history (link)
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