- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02555696
Abraxane in Treatment of Metastatic Breast Cancer
Assessment of Abraxane in Metastatic Breast Cancer in a Real-life Setting
Study Overview
Detailed Description
This observational program is aimed at gaining tolerability, safety and efficacy data with the routine use of Abraxane in its labelled indication in metastatic breast cancer. Additionally data on real life dosing in daily clinical routine will be analyzed.
A detailed record of the medical history including co-morbidities and pre-treatment regimens will allow analysis of the impact thereof on tolerability, dosage and efficacy.
This data might also be supportive for further treatment optimization of Abraxane in Metastatic Breast Cancer (MBC).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Feldkirch, Austria, 6800:
- LKH Feldkirch
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Graz, Austria, 8036:
- Medical University Graz
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Innsbruck, Austria, 6020:
- Medical University Innsbruck
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Leoben, Austria, 8700:
- LKH Leoben
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Linz, Austria, 4020:
- KH Barmherzige Schwestern Linz
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Salzburg, Austria, 5020:
- LKH Salzburg
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St. Pölten, Austria, 3100:
- LKH St. Pölten
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Steyr, Austria, 4400:
- LKH Steyr
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Vienna, Austria, 1090:
- Medical University Vienna
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Vienna, Austria, 1220:
- KH SMZ Ost
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Vöcklabruck, Austria, 4840:
- LKH Vöcklabruck
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Wels, Austria, 4600:
- Klinikum Wels
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Wr. Neustadt, Austria, 2700:
- LKH Wr. Neustadt
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with metastatic breast cancer (according to European Summary of Product characteristics (SmPC)
- Signed Informed Consent
- Participants > 18 Years of Age
Exclusion Criteria:
- Pregnant or lactating females
- Neutrophils <1.5 X 10^9/L
- Hypersensivity to nab-paclitaxel
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
nab-paclitaxel
nab-paclitaxel 260mg/m^2 in intravenous (IV) infusion every 3 weeks until progression or toxicity
|
nab-paclitaxel by IV infusion every 3 weeks until progression or toxicity
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: Up to 3 years
|
Includes the number of participants with adverse events
|
Up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response
Time Frame: Up to 3 years
|
Number of participants who achieve a response
|
Up to 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Guenter Voraberger, Celgene
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIPMS-Celgene-AUT-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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