Status:
COMPLETED
EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients
Lead Sponsor:
MediGene
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the efficacy, safety and tolerability of a therapy with EndoTAG-1 + paclitaxel in combination and EndoTAG-1 alone as a rescue therapy for patients with relapsed ...
Detailed Description
Breast cancer is still a major public health problem worldwide, as it is by far the most frequent neoplasm in women. In recent years so-called "profiling of breast cancer" with expression arrays has b...
Eligibility Criteria
Inclusion
- Histologically proven triple-receptor-negative metastatic or relapsed breast cancer
- Minimum interval of 6 months after the end of any previous taxane- containing chemotherapy regimen
- At least one tumor lesion measurable according to RECIST criteria
- Gender: female
- Age \>= 18 years old
- Negative pregnancy test (females of childbearing potential)
- Willingness to perform double-barrier-contraception during study and for 6 months post chemotherapy treatment
- ECOG performance status 0, 1 or 2
- Signed informed consent
Exclusion
- More than 1 previous chemotherapeutic treatment for metastatic or relapsed disease
- Major surgery \< 4 weeks prior to enrollment
- Immunotherapy \< 2 weeks prior to enrollment
- Severe pulmonary obstructive or restrictive disease
- Uncontrolled inflammatory disease (autoimmune or infectious)
- Clinically significant cardiac disease (NYHA stadium \> 2)
- Laboratory tests (hematology, chemistry) outside specified limits
- Pregnancy or nursing status
- Known positive HIV testing
- Known hypersensitivity to any component of the EndoTAG-1 or taxane formulations
- History of malignancy other than breast cancer \< 5 years prior to enrollment, except skin cancer (i.e. basal or squamous cell carcinoma) treated locally
- Known progressive cerebral metastasis (patients with cerebral metastases in a stable state or after successful surgical or radiological treatment are allowed to participate in the study)
- History of active or significant neurological disorder or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of central nervous system during the trial
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT00448305
Start Date
January 1 2007
End Date
March 1 2011
Last Update
January 5 2012
Active Locations (33)
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1
Institut Jules Bordet - Centre des Tumeurs de l'Université Libre de Bruxelles
Brussels, Belgium, 1000
2
CHU Brugmann
Brussels, Belgium
3
UZ Antwerpen
Edegem, Belgium
4
CHU Liège
Liège, Belgium