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Breast NeoplasmsPhase 2IV REXBC 02NCT00351858

Safety and Efficacy Study of the Trifunctional Antibody Ertumaxomab to Treat Patients With Advanced or Metastatic Breast Cancer

A Phase 2 study testing ertumaxomab in people with Breast Neoplasms and Breast Cancer, run by Neovii Biotech at 1 site in Belgium.

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 this study is to determine the safety and efficacy of the investigational trifunctional anti-Her-2/neu x anti-CD3 antibody ertumaxomab as treatment for hormone therapy refractory Her-2/neu 1+ or 2+ expressing advanced or metastatic breast cancer Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms, Breast Cancer
What is being tested?
ertumaxomab
How many people
40 participants
Where
1 siteBelgium
Study dates
Jul 2006to 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

  • Female gender, and if of child-bearing potential must have negative pregnancy test result within 2 days before enrolment and must agree to practice effective birth control during the study.
  • Aged 18 years and older.
  • Histologically or cytologically confirmed invasive breast cancer with stage IIIb or IV disease with documented progression.
  • Measurable disease according to RECIST.
  • Histologically documented advanced primary breast cancer or biopsy of metastatic site demonstrating HER-2/neu expression (HER-2/neu 1+ or 2+, determined by immunohistochemistry [IHC]). HER-2/neu 2+ patients must have a negative Fluorescence In Situ Hybridization [FISH] test result.
  • Hormone receptor status Estrogen Receptors (ERs) positive and/or Progesterone Receptors (PRs) positive.
Show all 43Show fewer
  • No prior treatment with mouse or rat antibodies.
  • Life expectancy of at least six months (if the life expectancy of a patient is unspecified she will be allowed to enter the study).
  • An Eastern Cooperative Oncology Group (ECOG) performance score of £ 1.
  • Patients must have had disease progression after hormonal therapy including at least one aromatase inhibitor.
  • Adequate hematological, liver and kidney function:
  • Thrombocytes ³ 100000 / mm³ (= 100 x 109 /l)
  • Hemoglobin ³ 10 g/dl
  • Neutrophil count ³ 1500/mm³ (= 1.5 x 109 /l)
  • WBC ³ 3 X 109 /l
  • Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate transaminase (SGPT) ≤ 2.5 x upper limit of normal (ULN)
  • Serum bilirubin ≤ 2 x ULN
  • Creatinine ≤ 1.5 x ULN or clearance ³ 60 ml/min
  • No life-threatening visceral disease.
  • No known brain or central nervous system metastases.
  • No symptomatic pleural effusions.
  • No symptomatic pericardial effusions.
  • No subjects whose only site of metastatic involvement is bone metastases with the exception of those with a measurable soft tissue component of the bone lesion seen with imaging that does not require palliative radiation intervention and/or the patient has a lytic bone lesion ³ 1 cm measured with radiography that can be followed for evidence of re-calcification.
  • No history of relevant cardiovascular disease:
  • LVEF within the institutional ranges of normal as measured by echocardiogram or MUGA scan
  • No prior uncontrolled or symptomatic congestive heart failure NYHA ³ 2
  • No myocardial infarction within the past two years
  • No uncontrolled or symptomatic cardiac arrhythmias
  • No severe dyspnea.
  • No pulmonary dysfunction or need for continuous supportive oxygen inhalation.
  • No other concurrent uncontrolled co-morbid illness.
  • No other concurrent malignancy, except treated basal cell or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix.
  • Patients with documented autoimmune diseases (such as lupus) are excluded from participation in the study unless a waiver is granted by the responsible medical monitor.
  • Patients with a human immunodeficiency virus, hepatitis B or hepatitis C positive status are excluded from participation in the study.
  • No prior or concurrent chemotherapy regimen for advanced or metastatic disease.
  • Prior neo-adjuvant or adjuvant chemotherapy is allowed provided it was stopped at least six months before study entry.
  • No concurrent hormone therapy (hormone therapy must be stopped at the screening visit).
  • At least 4 weeks since prior radiotherapy.
  • No concurrent immune therapy.
  • No concurrent corticosteroid therapy.
  • No regularly used medication for a health condition or comorbidity that might result in undue risk to the patient.
  • No prior investigational treatment for advanced or metastatic disease.
  • Able and willing to comply fully with the protocol.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Jules Bordet Institute, Free University of Brussels

    Brussels, 1000

Other trials in Belgium

About this study

Official title: Phase II Study of the Trifunctional Anti-HER-2/Neu x Anti-CD3 Antibody Ertumaxomab for Hormone Therapy Refractory Patients With Her-2/Neu 1+ or 2+ Expressing Advanced or Metastatic Breast Cancer

The purpose of this study is to determine the safety and efficacy of the investigational trifunctional anti-Her-2/neu x anti-CD3 antibody ertumaxomab as treatment for hormone therapy refractory Her-2/neu 1+ or 2+ expressing advanced or metastatic breast cancer

Read the detailed description

A multi-centre, phase II study of ertumaxomab in metastatic breast cancer patients who became progressive after hormonal therapy. Each eligible patient will receive three ascending doses of ertumaxomab, administered intravenously. Ertumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 7 days. Each patient will participate in this study for up to 7 months (includes the up to 21 days screening period, 14 days treatment period, and up to 180 days/6 months follow-up), with 3-monthly post-study follow-up until the patient becomes progressive.

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, low to moderate Her-2/neu expression
Medical subject headings
Breast Neoplasms

What participants receive

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

  • ertumaxomabDrug

What is being measured

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

  1. To demonstrate clinical efficacy of the investigational trifunctional antibody ertumaxomab for the treatment of hormone therapy refractory advanced or metastatic breast cancer tumors (stage IIIb or IV) which are known to express Her-2/neu (1+ or 2+)

Secondary outcomes (5)

  1. Time to progression

  2. Duration of response

  3. Time to response

  4. Clinical benefit of ertumaxomab (defined as the rate of confirmed complete remission, partial remission and stable disease)

  5. Tumor marker levels (CA 15-3 and CEA)

Timeline

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

  1. First posted13 Jul 2006 (estimated)
  2. Study startJul 2006
  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
NCT00351858
Sponsor's protocol ID
FBT-IVREXBC 02
Other IDs
EudraT number: 2005-004294-21
Acronym
IV REXBC 02
Status last verified
Apr 2015
First submitted
12 Jul 2006
Last updated
1 May 2015
Results posted
No

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

  • Lindhofer H, Mocikat R, Steipe B, Thierfelder S. Preferential species-restricted heavy/light chain pairing in rat/mouse quadromas. Implications for a single-step purification of bispecific antibodies. J Immunol. 1995 Jul 1;155(1):219-25.

    PubMed 7602098

  • 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

  • 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

  • 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

  • Zeidler R, Mayer A, Gires O, Schmitt B, Mack B, Lindhofer H, Wollenberg B, Walz A. TNFalpha contributes to the antitumor activity of a bispecific, trifunctional antibody. Anticancer Res. 2001 Sep-Oct;21(5):3499-503.

    PubMed 11848515

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ertumaxomab in people with Breast Neoplasms and Breast Cancer, run by Neovii Biotech at 1 site in Belgium.

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 43 inclusion and 0 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 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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?

To demonstrate clinical efficacy of the investigational trifunctional antibody ertumaxomab for the treatment of hormone therapy refractory advanced or metastatic breast cancer tumors (stage IIIb or IV) which are known to express Her-2/neu (1+ or 2+). 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 NCT00351858, which also lists 6 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 1 May 2015.

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