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

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neovii Biotech
• Treatments: Antibodies; Antibodies, Monoclonal

Criteria

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.