Cardiotoxicity of Adjuvant Trastuzumab | NCT00858039

Studies
Cardiotoxicity of Adjuvant Trastuzumab

NCT00858039

Sponsor

Royal Prince Alfred Hospital, Sydney, Australia

Status

Completed

Last Update Posted

Nov 5, 2014Estimated

Enrollment

220Actual

Phase

Not provided

Conditions

Breast Neoplasms
Heart Failure

Interventions

Not provided

Countries

Australia

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

Nov 2014

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

Feb 2009

Primary Completion Date

Jul 2013Actual

Completion Date

Jun 2014Actual

First Submitted Date

Mar 6, 2009

First Submission Date that Met QC Criteria

Mar 6, 2009

First Posted Date

Mar 9, 2009Estimated

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

Nov 4, 2014

Last Update Posted Date

Nov 5, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shom Goel, Breast Oncology Fellow, Royal Prince Alfred Hospital, Sydney, AustraliaPrincipal Investigator

Lead Sponsor

Royal Prince Alfred Hospital, Sydney, AustraliaOTHER

Collaborators

Not provided

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

Trastuzumab (Herceptin®) increases the chances of cure in patients with Her-2 overexpressing early breast cancer. Unfortunately, both the chemotherapy drugs used in this setting (anthracyclines) and trastuzumab are known to cause cardiac dysfunction in a proportion of patients. Patients who develop heart problems when taking trastuzumab might have to stop this treatment, which could jeopardise their chances of cure. N-terminal pro-B-type natriuretic peptide (NT pro-BNP) is a cardiac biomarker that is measured in the blood, the levels of which have been shown to indicate the presence of heart failure. Some early research has suggested that there may be a correlation between elevated NT pro-BNP and heart damage due to cancer chemotherapy and also trastuzumab. Troponin is another substance measured in the blood that can indicate heart damage. Finally, certain variations in an individual's genetic makeup (called polymorphisms) could put them at increased risk of heart damage from trastuzumab. Here we are studying whether any of these factors (NT pro-BNP levels, troponin levels, or certain genetic polymorphisms) can accurately predict who is at highest risk of trastuzumab-related cardiotoxicity.

The principal aim of this study is to evaluate the utility of NT pro-BNP as a predictive biomarker for the development of trastuzumab related cardiotoxicity (TRC). The investigators will also examine if single nucleotide polymorphisms in the HER2 gene or Fc-gamma-receptor genes predict for TRC.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

220Actual

Label	Type	Description	Intervention Names
Her-2 positive ESBC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiotoxicity (Cardiac death; grade 3/4 arrhythmia or ischaemia; NYHA Class 3 or 4 heart failure decline in LVEF by >10% to a level <55%; decline in LVEF by >5% to a level <50%)		Until 6 months after completing trastuzumab

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female 18 years or older
Histologically confirmed, completely excised invasive breast cancer with Her-2 overexpression
Primary surgery less than twelve weeks prior to registration
LVEF>50% as assessed by transthoracic echocardiogram or gated heart pool scan
Eastern Cooperative Oncology Group Performance Status 0-2
Adjuvant systemic treatment plan comprises at least three cycles of anthracycline chemotherapy AND 52 weeks of trastuzumab
Before patient registration, informed consent must be given according to local regulations.

Exclusion Criteria:

Pregnancy
Distant metastases from breast cancer
Any systemic chemotherapy prior to study entry

Accepts Healthy Volunteers

Sex

Female

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 presenting to tertiary referral medical oncology clinics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jane Beith, MBBS FRACP PhD	Sydney South West Area Health Service (Royal Prince Alfred Hospital)	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Prince Alfred Hospital		Sydney	New South Wales	2050	Australia
Royal North Shore Private Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31401102	Derived	Goel S, Liu J, Guo H, Barry W, Bell R, Murray B, Lynch J, Bastick P, Chantrill L, Kiely BE, Abdi E, Rutovitz J, Asghari R, Sullivan A, Harrison M, Kohonen-Corish M, Beith J. Decline in Left Ventricular Ejection Fraction Following Anthracyclines Predicts Trastuzumab Cardiotoxicity. JACC Heart Fail. 2019 Sep;7(9):795-804. doi: 10.1016/j.jchf.2019.04.014. Epub 2019 Aug 7.

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