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Metastatic Breast CancerPhase 2NCT00452140

Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer Progressing After Endocrine Treatment

A Phase 2 study testing ertumaxomab in people with Metastatic Breast Cancer and Advanced Breast Cancer, run by Neovii Biotech at 5 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
ertumaxomab
Type of treatment
Injection or infusion
How many people
40 participants
Where
5 sitesin 5 countries
Study dates
Mar 2007to Feb 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

5 sites in 5 countries.

5 sites in 5 countries

Austria1 site

  • Study site

    Study Site

Other trials in Austria

France1 site

  • Study site

    Study Site

Other trials in France

Germany1 site

  • Study site

    Study Sites

Other trials in Germany

Italy1 site

  • Study site

    Study Site

Other trials in Italy

Spain1 site

  • Study site

    Barcelona

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
ertumaxomab
Keywords
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
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ertumaxomabBiological

    10 µg, IV on day 0 followed by 100 µg every 7 days up to a maximum of 12 infusions.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (9)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2007 (estimated)
  2. Study startMar 2007
  3. Study completionFeb 2009

Why it stopped: company focus on other projects

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00452140
Sponsor's protocol ID
IV-ERT-BC-03
Other IDs
EudraT number: 2006-005017-36
Status last verified
May 2009
First submitted
26 Mar 2007
Last updated
19 May 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16707606

  • 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.

    PubMed 10901380

  • 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.

    PubMed 10415020

  • 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.

    PubMed 11588051

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ertumaxomab in people with Metastatic Breast Cancer and Advanced Breast Cancer, run by Neovii Biotech at 5 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Austria, France, Germany, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: company focus on other projects). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical efficacy measured by objective response rate (best response during the course of the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00452140, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2009.

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