Therapy Management With Nab-Paclitaxel in Daily Routine

Study Overview
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Brief Summary
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Despite treatment improvements in breast cancer, a large number of patients still progress to the metastatic stage. Metastatic breast cancer patients have an extremely unfavorable prognosis. Not only efficacy, but also quality of life are in the focus when planning a therapy or therapy sequence for metastatic breast cancer patients. Therapy options include anti-hormonal Therapy, antibody therapies, other targeted therapies and chemotherapies. One of the most effective chemotherapies in the adjuadjuvant and metastatic setting is paclitaxel. However drug handling and its side effects can compromise patients quality of life and can have an impact on the pharmacokinetics of the drug. In metastatic breast cancer patients increasing therapy efficacy and reduction of side effect frequency are considered to be advancements of therapy. One of these advancements is the development of a cremophor free and albumin bound paclitaxel, nab-Paclitaxel (Abraxane), which is thought to have a better efficacy and reduced toxicity profile. Nab-Paclitaxel is approved for the treatment of metastatic breast cancer after a failure of first-line therapy and when antracyclines are not indicated. The SERAPHINA study aims to investigate in the use of nab-Paclitaxel in daily routine and the frequency and perception of side effects. As a non-interventional study, the SERAPHINA Study will assess the patient characteristics and describe the patient cohort, in which nab-Paclitaxel is given. This includes age distribution and characteristics documented by the patients themselves.

Official Title
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Safety, Efficacy and Patient Reported Outcomes of Advanced Breast Cancer Patients: Therapy Management With Nab-Paclitaxel in Daily Routine - SERAPHINA

Conditions
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Metastatic Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with metastatic breast cancer in which a therapy with nab-paclitaxel was indicated by the treating physician Treatment of nab-Paclitaxel must either have not been started yet, or first application of nab-Paclitaxel was not prior to 21 days before study entry Female patients, age ≥18 years Invasive breast cancer (irrespective of status of BC, e.g. TNM, receptor status etc.) Metastatic or locally advanced, inoperable disease proven by clinical measures (i.e. standard imaging) Patients scheduled for nab-Paclitaxel treatment in daily routine before screening Patients, who are able and willing to sign the informed consent form Exclusion Criteria: Patient is currently enrolled, or will enroll in an interventional clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidemiological assessment of progression free survival (PFS) under real life conditions. | PFS defined as the time to the first progression or death after therapy start of nab-Paclitaxel. | A patient remains in the study for a maximum of 36 months or until death, whatever occurs first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of other prognostic characteristics | OS (overall survival) is defined as the time to death from therapy start of nab-Paclitaxel. Reason for death is taken into consideration as well (BBCS, breast cancer specific survival). | A patient remains in the study for a maximum of 36 months or until death, whatever occurs first | 
| Influence of age on the prognosis and quality of life. | Progression free survival, overall survival and quality of life assessed with PRO | A patient remains in the study for a maximum of 36 months or until death, whatever occurs first | 
| Incidence of adverse events, serious adverse events will be reported. | NCI Common Toxicity Criteria Version 4.03 | A patient remains in the study for a maximum of 36 months or until death, whatever occurs first | 
| Quality of life (FACT-B -Taxane, Version 4, nab-Paclitaxel specific questions, NCCN-Distress-Thermometer) | Patient reported (PRO) quality of life is assessed with standardized questionnaires (FACT-B, Version 4, FACT-Taxane, Version 4, nab-Paclitaxel specific questions, NCCN-Distress-Thermometer. | A patient remains in the study for a maximum of 36 months or until death, whatever occurs first | 
| Influence of breast cancerpatient characteristics on prognosis, adverse event frequencies, quality of life and therapy decision making. | The patient group is described by patient and tumor characteristics and a series of questionnaires assessing health and socioeconomic status and geriatric assessment status. These parameters that describe the patient cohort will be analyzed with regard to their influence on prognosis, adverse event frequencies, quality of life and therapy decision making. | A patient remains in the study for a maximum of 36 months or until death, whatever occurs first |