Nab-paclitaxel in Metastatic Breast Cancer Patients Failing Solvent Based Taxane (Tiffany)
|ClinicalTrials.gov Identifier: NCT01416558|
Recruitment Status : Terminated (Study was terminated because of extrem low recruitment)
First Posted : August 15, 2011
Last Update Posted : May 22, 2013
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Nab-Paclitaxel||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||July 2011|
|Primary Completion Date :||October 2012|
|Study Completion Date :||October 2012|
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
- Overall response rate (ORR) [ Time Frame: 3 years ]
- Toxicity of the therapy [ Time Frame: 3 years ]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 ]
- Duration of response [ Time Frame: 3 years ]
- Progression-free survival (PFS) [ Time Frame: 3 years ]
- Overall survival (OS) [ Time Frame: 3 years ]
- SPARC expression rate of the tissue of the primary and/or metastatic tumor [ Time Frame: 3 years ]
- Compliance of the therapy [ Time Frame: 3 years ]Number and percent of the patients with treatment modifications (dose delay / dose reduction / premature dicontinuation)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416558
|GBG Forschungs GmbH|
|Neu-Isenburg, Germany, 63263|