NCT01416558

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

A Multicenter Non-randomized Phase II Study to Evaluate Nab-paclitaxel in Metastatic Brest Cancer Patients Failing a Solvent Based Taxane as (Neo-)Adjuvant Treatment (Tiffany)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: GBG Forschungs GmbH · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective: To determine overall response rate (ORR) and to exclude that it is 20% or lower. Secondary Objectives: 1. To determine compliance and toxicity of the therapy. 2. To determine clinical benefit rate (CBR) in patients with measurable disease. 3. To determine duration of response. 4. To determine progression-free survival (PFS). 5. To determine overall survival. 6. To assess biomarkers, e.g. SPARC expression in the tissue of the primary or metastatic tumor.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Nab-Paclitaxel	Nab-Paclitaxel 125 mg/m2 i.v. over 30 min. weekly in 5 out of 6 weeks Given until progression, unacceptable toxicity, patient's request or withdrawal from Study

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2011-08-15
• Last updated: 2013-05-22

Locations

1 site across 1 country: Germany