Safety and Efficacy Study of the Trifunctional Antibody Ertumaxomab to Treat Patients With Advanced or Metastatic Breast Cancer (IV REXBC 02)

April 30, 2015 updated by: Neovii Biotech

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Drug: ertumaxomab

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.

Study Type

Interventional

Enrollment (Anticipated)

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

Belgium
- - Brussels, Belgium, 1000
    - Jules Bordet Institute, Free University of Brussels

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

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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.
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.

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 Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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+)

Secondary Outcome Measures

Outcome Measure
Time to progression
Duration of response
Time to response
Clinical benefit of ertumaxomab (defined as the rate of confirmed complete remission, partial remission and stable disease)
Tumor marker levels (CA 15-3 and CEA)

Collaborators and Investigators

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

Sponsor

Neovii Biotech

Investigators

Principal Investigator: Fatima Cardoso, MD, Brussels

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

July 1, 2006

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

July 12, 2006

First Submitted That Met QC Criteria

July 12, 2006

First Posted (Estimate)

July 13, 2006

Study Record Updates

Last Update Posted (Estimate)

May 1, 2015

Last Update Submitted That Met QC Criteria

April 30, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

FBT-IVREXBC 02
EudraT number: 2005-004294-21

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.