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

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

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

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer

Detailed 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?

• Study Type: Observational
• Enrollment (Actual): 705

Contacts and Locations

Study Locations

• Germany
  • Baden-Wuerttemberg
    • Freiburg, Baden-Wuerttemberg, Germany, 79108
      • iOMEDICO AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Adult female patients with metastatic breast cancer

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Adult female patients with MBC; This is an observational study, no interventions are specified

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: iOMEDICO AG
• Investigators: Principal Investigator: Christoph Salat, Prof., Haemato-Onkologische Schwerpunktpraxis Franz-Schrank-Strasse 2 80638 Munich, Germany

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: August 14, 2012
• First Submitted That Met QC Criteria: September 17, 2012
• First Posted (Estimate): September 21, 2012

Study Record Updates

• Last Update Posted (Actual): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: breast cancer; safety; peripheral neuropathy; Abraxane; Nab-Paclitaxel; daily routine; Nabucco; iOMEDICO
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IOM-02240