- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00522457
Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer After Progression on Trastuzumab Therapy
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
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Ontario
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Ottawa, Ontario, Canada
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Quebec
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Montreal, Quebec, Canada
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Minnesota
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Minneapolis, Minnesota, Forenede Stater
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater
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New York
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New York, New York, Forenede Stater
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Clinical Efficacy Measured by Objective Response Rate (Best Response During the Course of the Study)
Tidsramme: patients are monitored for 6 months
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patients are monitored for 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Duration of Response
Tidsramme: patients are monitored for 6 months
|
The study was prematurely terminated, therefore no participants were analyzed
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patients are monitored for 6 months
|
Clinical Benefit Rate
Tidsramme: patients are monitored for 6 months
|
The study was prematurely terminated, therefore no participants were analyzed
|
patients are monitored for 6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Gary Schwartz, MD, Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center; Lebanon, NH
Publikationer og nyttige links
Generelle publikationer
- Ruf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001 Oct 15;98(8):2526-34. doi: 10.1182/blood.v98.8.2526.
- Riesenberg R, Buchner A, Pohla H, Lindhofer H. Lysis of prostate carcinoma cells by trifunctional bispecific antibodies (alpha EpCAM x alpha CD3). J Histochem Cytochem. 2001 Jul;49(7):911-7. doi: 10.1177/002215540104900711.
- Zeidler R, Mysliwietz J, Csanady M, Walz A, Ziegler I, Schmitt B, Wollenberg B, Lindhofer H. The Fc-region of a new class of intact bispecific antibody mediates activation of accessory cells and NK cells and induces direct phagocytosis of tumour cells. Br J Cancer. 2000 Jul;83(2):261-6. doi: 10.1054/bjoc.2000.1237.
- Zeidler R, Reisbach G, Wollenberg B, Lang S, Chaubal S, Schmitt B, Lindhofer H. Simultaneous activation of T cells and accessory cells by a new class of intact bispecific antibody results in efficient tumor cell killing. J Immunol. 1999 Aug 1;163(3):1246-52.
- Kiewe P, Hasmuller S, Kahlert S, Heinrigs M, Rack B, Marme A, Korfel A, Jager M, Lindhofer H, Sommer H, Thiel E, Untch M. Phase I trial of the trifunctional anti-HER2 x anti-CD3 antibody ertumaxomab in metastatic breast cancer. Clin Cancer Res. 2006 May 15;12(10):3085-91. doi: 10.1158/1078-0432.CCR-05-2436.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IV-ERT-BC-04
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