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

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ClinicalTrials.gov Identifier: NCT01689610
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
iOMEDICO AG

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

Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 705 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Study to Investigate Efficacy and Safety of Nab-Paclitaxel in Patients With Metastatic Breast Cancer
Study Start Date : April 2012
Actual Primary Completion Date : November 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

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


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

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Germany
iOMEDICO AG
Freiburg, Baden-Wuerttemberg, Germany, 79108
Sponsors and Collaborators
iOMEDICO AG
Investigators
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Principal Investigator: Christoph Salat, Prof. Haemato-Onkologische Schwerpunktpraxis Franz-Schrank-Strasse 2 80638 Munich, Germany
More Information
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Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT01689610     History of Changes
Other Study ID Numbers: IOM-02240
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Keywords provided by iOMEDICO AG:
Nab-Paclitaxel
Abraxane
Nabucco
safety
 breast cancer
daily routine
peripheral neuropathy
iOMEDICO
Additional relevant MeSH terms:
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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