NCT01689610

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
705

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

3.6 years

First QC Date

August 14, 2012

Last Update Submit

June 19, 2018

Conditions

Metastatic Breast Cancer

Keywords

Nab-PaclitaxelAbraxaneNabuccosafetybreast cancerdaily routineperipheral neuropathyiOMEDICO

Outcome Measures

Primary Outcomes (1)

  • Time to Tumor Progression (TTP)

    6 months after last-patient-in (LPI)

Secondary Outcomes (12)

  • 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

  • +7 more secondary outcomes

Study Arms (1)

Adult female patients with MBC

This is an observational study, no interventions are specified

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult female patients with metastatic breast cancer

You may qualify if:

  • Female Patients with metastatic breast cancer, who are at least 18 years old (no upper age limit)

You may not qualify if:

  • Contraindication according to the summary of product characteristics of Abraxane®
  • No signed patient informed consent form available
  • pregnant or breastfeeding patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

iOMEDICO AG

Freiburg im Breisgau, Baden-Wurttemberg, 79108, Germany

Location

MeSH Terms

Conditions

Breast NeoplasmsPeripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Christoph Salat, Prof.

    Haemato-Onkologische Schwerpunktpraxis Franz-Schrank-Strasse 2 80638 Munich, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2012

First Posted

September 21, 2012

Study Start

April 1, 2012

Primary Completion

November 1, 2015

Study Completion

March 1, 2016

Last Updated

June 20, 2018

Record last verified: 2018-06

Locations

DE(1)