drugset / Trial / NCT01416558

Nab-paclitaxel in Metastatic Breast Cancer Patients Failing Solvent Based Taxane (Tiffany)

NCT01416558 ↗

Phase 2 Terminated 66 enrolled GBG Forschungs GmbH
NaSingle-groupOpen-labelTreatment

Summary

Nab-paclitaxel has demonstrated to be an active agent in breast cancer and probably a less toxic alternative to solvent based taxanes. It is indicated in metastatic breast cancer after failure of anthracyclines. However, most patients receive anthracyclines as well as taxanes as part of their (neo-)adjuvant therapy. There is currently no standard treatment for patients with an early relapse (\<12 months) after a taxane containing (neo-)adjuvant therapy. Nab-paclitaxel, a novel nano-particle encapsulated paclitaxel is expected to have only limited cross-resistant to solvent-based taxanes and might therefore be indicated in this setting.

Timeline

Start
2011-07
Primary completion
2012-10
Completion
2012-10

Outcome

Outcome not reported

Stopped (Enrollment): “Study was terminated because of extrem low recruitment”

Drugs

EvaluationDrugModalityDoseRoute
Subject Nab-paclitaxel Small molecule 125 mg/m2 Intravenous

Indications