Nab-paclitaxel in Metastatic Breast Cancer Patients Failing Solvent Based Taxane (Tiffany)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- Overall response rate (ORR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Toxicity of the therapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Number and percent of patients with Adverse Events (any Grade and Grade 3/4).
- Clinical benefit rate (CBR) in patients with measurable disease [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Progression-free survival (PFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Overall survival (OS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- SPARC expression rate of the tissue of the primary and/or metastatic tumor [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Compliance of the therapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Number and percent of the patients with treatment modifications (dose delay / dose reduction / premature dicontinuation)
|Study Start Date:||July 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
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
To determine overall response rate (ORR) and to exclude that it is 20% or lower.
- To determine compliance and toxicity of the therapy.
- To determine clinical benefit rate (CBR) in patients with measurable disease.
- To determine duration of response.
- To determine progression-free survival (PFS).
- To determine overall survival.
- To assess biomarkers, e.g. SPARC expression in the tissue of the primary or metastatic tumor.