Status:
TERMINATED
Safety and Efficacy Study of the Trifunctional Antibody Ertumaxomab to Treat Patients With Advanced or Metastatic Breast Cancer
Lead Sponsor:
Neovii Biotech
Conditions:
Breast Neoplasms
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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/...
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 ertumaxoma...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00351858
Start Date
July 1 2006
End Date
February 1 2009
Last Update
May 1 2015
Active Locations (1)
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1
Jules Bordet Institute, Free University of Brussels
Brussels, Belgium, 1000