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 or metastatic triple receptor negative breast cancer (a special subgroup of breast cancer).
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 become common and it was suggested that the results will allow individualization of care. Breast cancer may now be subclassified into luminal, basal, and HER-2 subtypes with distinct differences in prognosis and response to therapy. About 80% of all basal-like-breast cancers possess a so-called "triple-receptor-negative" phenotype. Patients with "triple receptor negative breast cancer" have a complete absence of hormone receptors incl. HER-2, an aggressive clinical course and a paucity of treatment options. The only therapeutic option is chemotherapy and in this respect the choice of cytostatic agents is limited. Against this background, the study tries to find another therapeutic option by combining a vascular-disrupting activity with the cytostatic effects of paclitaxel in the study drug EndoTAG-1. Comparison: EndoTAG-1 + paclitaxel (combination therapy) and EndoTAG-1 (monotherapy) in comparison to paclitaxel (control group)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
143
EndoTAG-1 22 mg/m² + Paclitaxel 70 mg/m² weekly
EndoTAG-1 44 mg/m² twice weekly
Paclitaxel 90 mg/m² weekly
4-month progression free survival (PFS) rate
Time frame: 4 month
median progression free survival (PFS) time
Time frame: progression of last patient
tumor response
Time frame: Last patient out
4-month survival rate
Time frame: 4-month
median overall survival time
Time frame: Withdrawal or death of last patient
pain assessment
Time frame: Last patient out
clinical benefit assessment via quality of life (QoL)Scale
Time frame: Last patient out
adverse events
Time frame: Last patient out
laboratory values
Time frame: Last patient out
dose variations
Time frame: Last patient out
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Brussels, Belgium
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Liège, Belgium
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Nice, France
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Tours, France
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Villejuif, France
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