Non-interventional Study With Nab-Paclitaxel (Abraxane®)

Study Overview
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Brief Summary
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The purpose of this non-interventional study is to collect data on the efficacy and safety of Nab-Paclitaxel in the routine application.

Detailed Description
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The main focus of this non-interventional study is set on answering the following questions: Can the results observed in controlled clinical trials regarding efficacy and safety be reproduced in the routine clinical setting? Are the side-effects of nab-paclitaxel therapy observed in this study comparable to the previously described safety-profile in terms of frequency and intensity? What are the main reasons for modification or termination of the nab-paclitaxel therapy? How does nab-paclitaxel therapy influence the patients' quality of life? What are the criteria for selecting nab-paclitaxel as therapy for metastatic breast cancer?

Official Title
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Non-Interventional Study to Investigate Efficacy and Safety of Nab-Paclitaxel in Patients With Metastatic Breast Cancer

Conditions
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Metastatic Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Patients with metastatic breast cancer, who are at least 18 years old (no upper age limit) Exclusion Criteria: Contraindication according to the summary of product characteristics of Abraxane® No signed patient informed consent form available pregnant or breastfeeding patients.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult female patients with MBC<br>This is an observational study, no interventions are specified | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Tumor Progression (TTP) |  | 6 months after last-patient-in (LPI) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) |  | 6 months after last-patient-in (LPI) | 
| Overall survival (OS) |  | 6 months after last-patient-in (LPI) | 
| Time to treatment discontinuation |  | 6 months after last-patient-in (LPI) | 
| Number of participants with Adverse Events as a measure of safety and tolerability |  | Until 30 days after discontinuation of Nab-paclitaxel | 
| Relative dosage of Nab-Paclitaxel |  | Until discontinuation of Nab-Paclitaxel, up to 6 month | 
| Intensity of peripheral neuropathy |  | Until discontinuation of Nab-Paclitaxel, up to 6 month | 
| Occurence of neutropenia |  | Until discontinuation of Nab-Paclitaxel, up to 6 month | 
| Necessity of supportive medication (e.g. haematopoetic growth factors, analgetics, antibiotics and antiemetics) |  | Until discontinuation of Nab-Paclitaxel, up to 6 month | 
| Patient reported outcome on Quality of life and adverse events | Assessed by questionnaires FACT-G, FACT-B, FACT-Taxanes and a pain questionnaire of the Robert-Koch-Institute. | At baseline, 3 and 6 months after start of treatment | 
| Reasons for dose modifications or discontinuation of treatment |  | Until discontinuation of Nab-Paclitaxel, up to 6 month | 
| Occurence of febrile neutropenia |  | Until discontinuation of Nab-Paclitaxel, up to 6 month | 
| Occurence of peripheral neuropathy |  | Until discontinuation of Nab-Paclitaxel, up to 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nab-Paclitaxel, Abraxane, Nabucco, safety, breast cancer, daily routine, peripheral neuropathy, iOMEDICO