Abraxane in Treatment of Metastatic Breast Cancer | NCT02555696

Studies
Abraxane in Treatment of Metastatic Breast Cancer

NCT02555696

Sponsor

Celgene

Status

Completed

Last Update Posted

Feb 23, 2017Actual

Enrollment

203Actual

Phase

Not provided

Conditions

Metastatic Breast Cancer

Interventions

nab-paclitaxel

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 31, 2012Actual

Primary Completion Date

Feb 28, 2016Actual

Completion Date

Dec 31, 2016Actual

First Submitted Date

Sep 18, 2015

First Submission Date that Met QC Criteria

Sep 18, 2015

First Posted Date

Sep 21, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2017

Last Update Posted Date

Feb 23, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This observational project is collecting tolerability, safety and efficacy data with the routine use of Abraxane in the treatment of metastatic breast cancer. Additionally data on the dosage of Abraxane and general data on the disease and the health status of the patient will be collected.

Detailed Description

This observational program is aimed at gaining tolerability, safety and efficacy data with the routine use of Abraxane in its labelled indication in metastatic breast cancer. Additionally data on real life dosing in daily clinical routine will be analyzed.

A detailed record of the medical history including co-morbidities and pre-treatment regimens will allow analysis of the impact thereof on tolerability, dosage and efficacy.

This data might also be supportive for further treatment optimization of Abraxane in Metastatic Breast Cancer (MBC).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

203Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
nab-paclitaxel		nab-paclitaxel 260mg/m^2 in intravenous (IV) infusion every 3 weeks until progression or toxicity	Drug: nab-paclitaxel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nab-paclitaxel	Drug	nab-paclitaxel by IV infusion every 3 weeks until progression or toxicity	nab-paclitaxel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Events	Includes the number of participants with adverse events	Up to 3 years

Secondary Outcomes

Measure	Description	Time Frame
Overall Response	Number of participants who achieve a response	Up to 3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with metastatic breast cancer (according to European Summary of Product characteristics (SmPC)
Signed Informed Consent
Participants > 18 Years of Age

Exclusion Criteria:

Pregnant or lactating females
Neutrophils <1.5 X 10^9/L
Hypersensivity to nab-paclitaxel

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with metastatic breast cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guenter Voraberger	Celgene	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
LKH Feldkirch		Feldkirch		6800:	Austria
Medical University Graz

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C520255	130-nm albumin-bound paclitaxel
D000068196	Albumin-Bound Paclitaxel

Ancestor Terms

ID	Term
D017239	Paclitaxel
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840

Browse Leaves

Not provided

Browse Branches

Not provided