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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
Sponsor:
Information provided by:
Neovii Biotech

Brief Summary:

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

Detailed Description:
An open-label, non-randomized, uncontrolled, one-stage, phase II study evaluating the efficacy and safety of the investigational trifunctional bispecific antibody ertumaxomab (anti-Her-2/neu x anti-CD3) for the treatment of hormone therapy refractory advanced or metastatic breast cancer tumours (stage IIIb or IV) which are known to express HER-2/neu (1+ or 2+/FISH negative).Ertumaxomab will be administered at 7 day intervals by constant rate 3 hour intravenous (i.v.) infusions according to the following sequential dose schedule: 10 µg (day 0) and thereafter 100 µg flat doses once every 7 days (± 1 day) for a maximum of up to 12 weeks or until disease progression or any other unacceptable toxicity.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


Intervention Details:
  • Biological: ertumaxomab
    10 µg, IV on day 0 followed by 100 µg every 7 days up to a maximum of 12 infusions.


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

Secondary Outcome Measures :
  1. Efficacy:
  2. Clinical benefit rate
  3. Duration of response
  4. Time to progression (TTP)
  5. Safety:
  6. Incidence of adverse events (AEs)
  7. Presence of human anti-murine antibodies after ertumaxomab infusion
  8. Vital signs
  9. Laboratory parameters


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  • 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

Information from the National Library of Medicine

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


Locations
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Austria
Study site, Austria
France
Study site, France
Germany
Study sites, Germany
Italy
Study site, Italy
Spain
Barcelona, Spain
Sponsors and Collaborators
Neovii Biotech
Investigators
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Principal Investigator: José Baselga / Javier Cortes Hospital Vall d'Hebron, Barcelona, Spain

Publications:
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Responsible Party: Fresenius Biotech GmbH
ClinicalTrials.gov Identifier: NCT00452140     History of Changes
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
Keywords provided by Neovii Biotech:
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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs