Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-03-06 @ 9:34 AM
Study NCT ID:
NCT01416558
Status:
TERMINATED
Last Update Posted:
2013-05-22
First Post:
2011-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nab-paclitaxel in Metastatic Breast Cancer Patients Failing Solvent Based Taxane (Tiffany)
Sponsor:
GBG Forschungs GmbH
Organization:
Study Overview
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)
Status:
TERMINATED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated because of extrem low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-000075-13 | EUDRACT_NUMBER | None | View |