We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01689610
First Posted: September 21, 2012
Last Update Posted: June 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
iOMEDICO AG
  Purpose
The purpose of this non-interventional study is to collect data on the efficacy and safety of Nab-Paclitaxel in the routine application.

Condition
Metastatic Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nabucco - Non-Interventional Study to Investigate Efficacy and Safety of Nab-Paclitaxel in Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by iOMEDICO AG:

Primary Outcome Measures:
  • Time to Tumor Progression (TTP) [ Time Frame: 6 months after last-patient-in (LPI) ]

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

  • Reasons for dose modifications or discontinuation of treatment [ Time Frame: Until discontinuation of Nab-Paclitaxel, up to 6 month ]
  • Occurence of febrile neutropenia [ Time Frame: Until discontinuation of Nab-Paclitaxel, up to 6 month ]
  • Occurence of peripheral neuropathy [ Time Frame: Until discontinuation of Nab-Paclitaxel, up to 6 month ]

Enrollment: 705
Study Start Date: April 2012
Study Completion Date: March 2016
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adult female patients with MBC
This is an observational study, no interventions are specified

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?
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult female patients with metastatic breast cancer
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689610


Locations
Germany
iOMEDICO AG
Freiburg, Baden-Wuerttemberg, Germany, 79108
Sponsors and Collaborators
iOMEDICO AG
Investigators
Principal Investigator: Christoph Salat, Prof. Haemato-Onkologische Schwerpunktpraxis Franz-Schrank-Strasse 2 80638 Munich, Germany
  More Information

Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT01689610     History of Changes
Other Study ID Numbers: IOM-02240
First Submitted: August 14, 2012
First Posted: September 21, 2012
Last Update Posted: June 1, 2016
Last Verified: May 2016

Keywords provided by iOMEDICO AG:
Nab-Paclitaxel
Abraxane
Nabucco
safety
breast cancer
daily routine
peripheral neuropathy
iOMEDICO

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action