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

iOMEDICO

Status: Completed

Conditions: Metastatic Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01689610

IOM-02240

Details and patient eligibility

About

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

Full description

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?

Enrollment: 705 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

705 participants in 1 patient group

Adult female patients with MBC

Description:

This is an observational study, no interventions are specified