Status:
TERMINATED
Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer Progressing After Endocrine Treatment
Lead Sponsor:
Neovii Biotech
Conditions:
Metastatic Breast Cancer
Advanced Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 a...
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-CD...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00452140
Start Date
March 1 2007
End Date
February 1 2009
Last Update
May 19 2009
Active Locations (5)
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1
Study Site, Austria
2
Study Site, France
3
Study Sites, Germany
4
Study Site, Italy