Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer After Progression on Trastuzumab Therapy
This study has been terminated.
(change in development plan, not due to safety concerns.)
Sponsor:
Fresenius Biotech GmbH
Collaborator:
Fresenius Biotech North America
Information provided by:
Fresenius Biotech GmbH
ClinicalTrials.gov Identifier:
NCT00522457
First received: August 28, 2007
Last updated: April 28, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Breast Cancer Advanced Breast Cancer |
Drug: ertumaxomab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Trastuzumab
U.S. FDA Resources
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) [ Time Frame: patients are monitored for 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Duration of Response [ Time Frame: patients are monitored for 6 months ] [ Designated as safety issue: No ]The study was prematurely terminated, therefore no participants were analyzed
- Clinical Benefit Rate [ Time Frame: patients are monitored for 6 months ] [ Designated as safety issue: No ]The study was prematurely terminated, therefore no participants were analyzed
| Enrollment: | 19 |
| Study Start Date: | January 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: ertumaxomab
Ertumaxomab will be intravenously administered to see if it can increase the patient's objective response rate.
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 µg (day 0); 100 µg (day 7 ± 1 day) and 100 µg (day 14 ± 1 day) (flat doses).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
- Eastern Cooperative Oncology Group (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, Human immunodeficiency virus (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
Locations
| United States, Minnesota | |
| Minneapolis, Minnesota, United States | |
| United States, New Hampshire | |
| Lebanon, New Hampshire, United States | |
| United States, New York | |
| New York, New York, United States | |
| Canada, Ontario | |
| Ottawa, Ontario, Canada | |
| Canada, Quebec | |
| Montreal, Quebec, Canada | |
Sponsors and Collaborators
Fresenius Biotech GmbH
Fresenius Biotech North America
Investigators
| Principal Investigator: | Gary Schwartz, MD | Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center; Lebanon, NH |
More Information
Additional Information:
Publications:
| Responsible Party: | Manager of Regulatory Affairs, Fresenius Biotech North America |
| ClinicalTrials.gov Identifier: | NCT00522457 History of Changes |
| Other Study ID Numbers: | IV-ERT-BC-04 |
| Study First Received: | August 28, 2007 |
| Results First Received: | March 1, 2011 |
| Last Updated: | April 28, 2011 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Fresenius Biotech GmbH:
|
Breast Cancer investigational drug drug therapy Antineoplastic Protocols Immunotherapy Metastatic breast cancer |
Advanced breast cancer Stage IV breast cancer Her-2/neu expressing breast cancer Her-2/neu Trastuzumab refractory |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Trastuzumab |
Antibodies, Monoclonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013