Abstract OT3-02-09: Seraphina – Safety efficacy and patient reported outcomes of advanced breast cancer patients: Therapy management with NAB-paclitaxel in daily routine
Authors: Fasching PA , Wallwiener M , Lux MP , Mueller V , Schneeweiss A , Tesch H , Brucker SY , Haeberle L , Spall T , Belleville E , Lück H-J 
Published: May 2016

BACKGROUND

Treatment of patients with advanced breast cancer (ABC) has evolved significantly. Nevertheless, further improvement in ABC treatment is a high medical need. Besides the prolongation of progression free survival (PFS) and overall survival (OS) the major objective of new therapeutic approaches is the enhancement of quality of life (QoL). A recent advance for the treatment of ABC was the development of the cremophor-free albumin-bound paclitaxel, nab-Paclitaxel.

SPECIFIC AIMS/TRIAL DESIGN

The aim of this non-interventional study is the analysis of efficacy and safety data of ABC patients within routine treatment with nab-Paclitaxel. A key focus will be the assessment of patient reported outcomes (PRO), health economic aspects and the influence of breast cancer patient characteristics on prognosis, adverse event frequencies, PRO and therapy decision making. Patients with ABC, who experienced failure of first-line treatment for metastatic disease and for whom standard anthracycline-containing therapy is not indicated, will be followed up under real-life conditions. Sixty sites, equally distributed with regard to their organizational structure (hospital and office based) and medical disciplines (gyneco-oncologists and medical oncologists) will document 1,200 patients. The primary objective is the assessment of PFS under real-life conditions. Secondary objectives include the assessment of overall and breast cancer specific survival, the influence of age on prognosis and QoL, as well as the incidence of (serious) adverse events (AE). PRO including FACT-B, FACT-Taxane, and nab-Paclitaxel treatment specific questions will be collected in a web based application and compared to paper based reporting. Furthermore, biomaterials will be collected to allow translational research projects.

ELIGIBILITY CRITERIA:

Adult women (&gt;18 years) with ABC and treated with nab-Paclitaxel.

STATISTICAL METHODS/TARGET ACCRUAL:

In Germany nab-Paclitaxel is indicated for patients with metastatic breast cancer after failure of a previous therapy in ABC. In this therapeutic setting several studies have shown high efficacy and acceptable toxicity. However, populations within clinical trials are selected and may be different from the general patient population in clinical practice. Therefore this study aims at the capture of PFS, PRO and AE in the general population for which nab-Paclitaxel is used in clinical practice. Nab-Paclitaxel treatment will be documented over a period of up to 6 months, followed by a 30 months progression/ survival follow-up. Target accrual is 1,200 patients. We assume that at most 10% are lost to follow-up before the median survival time is reached. Kaplan-Meier curves will be calculated, especially the median survival time with 95% confidence interval.

Citation Format: Fasching PA, Wallwiener M, Lux MP, Mueller V, Schneeweiss A, Tesch H, Brucker SY, Haeberle L, Spall T, Belleville E, Lück H-J. Seraphina – Safety efficacy and patient reported outcomes of advanced breast cancer patients: Therapy management with NAB-paclitaxel in daily routine. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr OT3-02-09.