Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT01416558
Brief 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.
Study:
NCT01416558
Study Brief:
Protocol Section:
NCT01416558