Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer Progressing After Endocrine Treatment
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ClinicalTrials.gov Identifier: NCT00452140 |
Recruitment Status :
Terminated
(company focus on other projects)
First Posted : March 27, 2007
Last Update Posted : May 19, 2009
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The purpose of the study is to demonstrate clinical efficacy of the investigational trifunctional bispecific antibody ertumaxomab for treatment of patients with HER-2/neu 1+ or 2+ (FISH-) expressing advanced or metastatic breast cancer (stage III b/IV) which has progressed after endocrine therapy.
Ertumaxomab is a trifunctional bispecific antibody targeting Her-2/neu 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 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 or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Breast Cancer Advanced Breast Cancer | Biological: ertumaxomab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study for Repeated Dosing of the Trifunctional Bispecific Anti-HER-2/Neu x Anti-CD3 Antibody Ertumaxomab in Patients With HER-2/Neu 1+ or 2+/FISH Negative Expressing Advanced or Metastatic Breast Cancer (Stage IIIb/IV) Progressing After Endocrine Treatment |
Study Start Date : | March 2007 |
Actual Study Completion Date : | February 2009 |

- Biological: ertumaxomab
10 µg, IV on day 0 followed by 100 µg every 7 days up to a maximum of 12 infusions.
- Clinical efficacy measured by objective response rate (best response during the course of the study)
- Efficacy:
- Clinical benefit rate
- Duration of response
- Time to progression (TTP)
- Safety:
- Incidence of adverse events (AEs)
- Presence of human anti-murine antibodies after ertumaxomab infusion
- Vital signs
- Laboratory parameters

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Signed and dated informed consent form
- Women ≥ 18 years, negative pregnancy test at screening life expectancy of at least 6 months
- Locally advanced (stage IIIb) or 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/neu expression 1+ or 2+ / FISH negative
- Estrogen Receptors (ERs) and/or Progesterone Receptors (PRs) positive
- Prior adequate endocrine therapy for advanced or metastatic disease
- Disease progression during or after endocrine therapy
- No prior treatment with mouse or rat antibodies
- ECOG performance score of ≤ 1
- Adequate hematological, liver and kidney function
Exclusion Criteria:
- Women who are pregnant or breast-feeding
- Known HIV infection or Presence of autoimmune disease or other Concurrent non-malignant co-morbidities that are uncontrolled
- History or symptoms indicative of brain or CNS 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)
- Documented acute or chronic infection requiring antibiotic treatment
- Any concurrent chemo-, hormonal, immuno- or corticoid therapy
- Any prior chemotherapy for advanced or metastatic disease
- Any concurrent investigational treatment for advanced or metastatic disease
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History of relevant cardiovascular disease as follows:
- Left ventricular ejection fraction (LVEF) below the institution's lower limit of normal, based on echocardiography (ECG) at rest
- Uncontrolled or symptomatic congestive heart failure (New York Heart Association (NYHA) > 2
- Uncontrolled or symptomatic arrhythmia and/or angina pectoris
- Myocardial infarction during the last 2 years

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452140
Austria | |
Study site, Austria | |
France | |
Study site, France | |
Germany | |
Study sites, Germany | |
Italy | |
Study site, Italy | |
Spain | |
Barcelona, Spain |
Principal Investigator: | José Baselga / Javier Cortes | Hospital Vall d'Hebron, Barcelona, Spain |
Responsible Party: | Fresenius Biotech GmbH |
ClinicalTrials.gov Identifier: | NCT00452140 |
Other Study ID Numbers: |
IV-ERT-BC-03 EudraT number: 2006-005017-36 |
First Posted: | March 27, 2007 Key Record Dates |
Last Update Posted: | May 19, 2009 |
Last Verified: | May 2009 |
Breast Cancer investigational drug drug therapy Antineoplastic Protocols Immunotherapy Metastatic breast cancer |
Advanced breast cancer Stage III to IV breast cancer Hormonal therapy refractory Failure of hormonal therapy Her-2/neu expressing breast cancer Her-2/neu |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |