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Completed

NCT Number: NCT01689610

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

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

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

iOMEDICO AG

Freiburg im Breisgau, Baden-Wurttemberg, 79108, Germany

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Time to Tumor Progression (TTP)

    Time frame: 6 months after last-patient-in (LPI)

Secondary outcomes

  1. Overall Response Rate (ORR)

    Time frame: 6 months after last-patient-in (LPI)

  2. Overall survival (OS)

    Time frame: 6 months after last-patient-in (LPI)

  3. Time to treatment discontinuation

    Time frame: 6 months after last-patient-in (LPI)

  4. Number of participants with Adverse Events as a measure of safety and tolerability

    Time frame: Until 30 days after discontinuation of Nab-paclitaxel

  5. Relative dosage of Nab-Paclitaxel

    Time frame: Until discontinuation of Nab-Paclitaxel, up to 6 month

  6. Intensity of peripheral neuropathy

    Time frame: Until discontinuation of Nab-Paclitaxel, up to 6 month

  7. Occurence of neutropenia

    Time frame: Until discontinuation of Nab-Paclitaxel, up to 6 month

  8. Necessity of supportive medication (e.g. haematopoetic growth factors, analgetics, antibiotics and antiemetics)

    Time frame: Until discontinuation of Nab-Paclitaxel, up to 6 month

  9. 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.

  10. Reasons for dose modifications or discontinuation of treatment

    Time frame: Until discontinuation of Nab-Paclitaxel, up to 6 month

  11. Occurence of febrile neutropenia

    Time frame: Until discontinuation of Nab-Paclitaxel, up to 6 month

  12. Occurence of peripheral neuropathy

    Time frame: Until discontinuation of Nab-Paclitaxel, up to 6 month

Sponsors and collaborators

Lead sponsor

iOMEDICO AG

Industry

Registry information

Official study title

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

Acronym: NABUCCO

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Sep 21, 2012
Registry last updated
Jun 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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