Nab-paclitaxel in Metastatic Breast Cancer Patients Failing Solvent Based Taxane (Tiffany)
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|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|
|Actual Primary Completion Date :||October 2012|
|Actual 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416558
|GBG Forschungs GmbH|
|Neu-Isenburg, Germany, 63263|