Cardiac Toxicity in Medical Treatment of Breast Cancer | NCT02440620

Studies
Cardiac Toxicity in Medical Treatment of Breast Cancer

NCT02440620

Sponsor

Odense University Hospital

Status

Completed

Last Update Posted

May 1, 2019Actual

Enrollment

45Actual

Phase

Not provided

Conditions

Heart Failure
Breast Cancer

Interventions

Not provided

Countries

Denmark

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

Apr 2019

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

Oct 2014Actual

Primary Completion Date

Aug 2018Actual

Completion Date

Aug 2018Actual

First Submitted Date

Apr 29, 2015

First Submission Date that Met QC Criteria

May 7, 2015

First Posted Date

May 12, 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

Apr 30, 2019

Last Update Posted Date

May 1, 2019Actual

Name	Class
University of Southern Denmark	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 study will describe the epidemiology including prognosis of heart failure related to treatment with anthracycline and trastuzumab for breast cancer.

In a prospective study Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer patients scheduled for trastuzumab treatment at Odense University Hospital, will be offered advanced echocardiographic examination, test of bio-markers and genetic markers for the purpose of investigating if early identification of patients in particular risk of developing heart failure is feasible.

Detailed Description

Not provided

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

Retention

Enrollment

45Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Global longitudinal strain by two dimentional speckle tracking.		Change in outcome from initiation of trastuzumab treatment and after 3,6, and 9 month.
Ratio between the mitral E velocity and early diastolic maximum global strain rate (E/SRE).		Change in outcome from initiation of trastuzumab treatment and after 3,6, and 9 month.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of HER2 positive breast cancer
Adjuvant treatment with trastuzumab

Exclusion Criteria:

Left ventricle ejection fraction (LVEF) <50%
Chronic or persistent atrial fibrillation
History of moderate or severe valvular heart disease.

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 HER2 positive breast cancer in adjuvant treatment with trastuzumab.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacob Moeller, MD, DMsc	Odense University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odense University Hospital		Odense C		5000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Blood samples will be analyzed for N-terminal proBNP and ultra-sensitive TnT. Targeted sequencing of a limited number of well-known genes related to heart failure will be conducted and analysis of potential future biomarkers related to heart failure is possible from blood samples stored in a biobank.