NCT00448305

EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients

An Open-label, Randomized, Controlled Phase-II Trial Evaluating the Efficacy and Safety of EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: MediGene · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 or metastatic triple receptor negative breast cancer (a special subgroup of breast cancer).

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 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)

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	EndoTAG-1 + paclitaxel	EndoTAG-1 22 mg/m² + Paclitaxel 70 mg/m² weekly
DRUG	EndoTAG-1	EndoTAG-1 44 mg/m² twice weekly
DRUG	Paclitaxel	Paclitaxel 90 mg/m² weekly

Timeline

• Start date: 2007-01-01
• Primary completion: 2010-02-01
• Completion: 2011-03-01
• First posted: 2007-03-16
• Last updated: 2012-01-05

Locations

33 sites across 6 countries: Belgium, France, India, Poland, Romania, Ukraine