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

May 18, 2009 updated by: Neovii Biotech

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical efficacy measured by objective response rate (best response during the course of the study)

Secondary Outcome Measures

Outcome Measure
Duration of response
Vital signs
Efficacy:
Safety:
Clinical benefit rate
Time to progression (TTP)
Incidence of adverse events (AEs)
Presence of human anti-murine antibodies after ertumaxomab infusion
Laboratory parameters

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neovii Biotech

Investigators

  • Principal Investigator: José Baselga / Javier Cortes, Hospital Vall d'Hebron, Barcelona, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion (ACTUAL)

February 1, 2009

Study Registration Dates

First Submitted

March 26, 2007

First Submitted That Met QC Criteria

March 26, 2007

First Posted (ESTIMATE)

March 27, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 19, 2009

Last Update Submitted That Met QC Criteria

May 18, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IV-ERT-BC-03
  • EudraT number: 2006-005017-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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