NCT00968682

Brief Summary

RATIONALE: Studying samples of blood in the laboratory from patients with cancer treated with trastuzumab may help doctors learn more about biomarkers related to heart dysfunction. It may also help doctors predict which patients will develop heart dysfunction. PURPOSE: This clinical trial is studying biomarkers to see how well they predict heart dysfunction in women with breast cancer treated with trastuzumab.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
480

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

14 active sites

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, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Last Updated

December 31, 2014

Status Verified

August 1, 2014

Enrollment Period

6 years

First QC Date

August 28, 2009

Last Update Submit

December 30, 2014

Conditions

Breast CancerCardiac Toxicity

Keywords

cardiac toxicityHER2-positive breast cancerstage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancer

Outcome Measures

Primary Outcomes (2)

  • Cardiac biomarker levels in predicting cardiac dysfunction

    End of trial

  • Development of a predictive model for use based on the most accurate and sensitive combination of biomarkers

    End of trial

Interventions

trastuzumabBIOLOGICAL
laboratory biomarker analysisOTHER
assessment of therapy complicationsPROCEDURE

Eligibility Criteria

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

Patients diagnosed with HER2 positive breast cancer, who are foreseen for neoadjuvant and/or adjuvant treatment with chemotherapy and Trastuzumab either sequentially or in combination or single agent Trastuzumab. Patients enrolled on BETH or ALTTO are also eligible.

You may qualify if:

  • HER-2 positive breast cancer by immunohistochemistry and/or fluorescence in-situ hybridisation.
  • Planned neoadjuvant and/or adjuvant treatment with chemotherapy and Trastuzumab either sequentially or in combination or single agent Trastuzumab.
  • years of age or older.
  • Treatment with curative intent.
  • ECOG Performance status 0, 1 or 2.
  • Adequate cardiac function, with MUGA or Echocardiograph \> 50%.
  • Written informed consent.

You may not qualify if:

  • Presence of a medical or psychiatric condition, which, in the opinion of the investigator, would potentially pose a risk to the patient by participating in this trial.
  • Evidence of metastatic disease.
  • Patients with uncontrolled hypertension (sustained systolic blood pressure \>180mmHg or diastolic blood pressure \>100mmHg), significant valvular disease (aortic or mitral regurgitation of 3 or 4+/ 4+ severity or stenosis of either valve), history of uncontrolled cardiac arrhythmias, prior symptomatic or asymptomatic myocardial infarction or angina pectoris requiring anti-anginal medication.
  • Prior anthracycline or Trastuzumab therapy.
  • Inability to give informed consent for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Bons Secours Hospital

Cork, Ireland

Location

Cork University Hospital

Cork, Ireland

Location

Our Ladies of Lourdes Hospital

Drogheda, Ireland

Location

Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital

Dublin, 24, Ireland

Location

St. Vincent's University Hospital

Dublin, 4, Ireland

Location

Mater Misericordiae University Hospital

Dublin, 7, Ireland

Location

St. James's Hospital

Dublin, 8, Ireland

Location

Beaumont Hospital

Dublin, 9, Ireland

Location

Mater Private Hospital

Dublin, Ireland

Location

University College Hospital

Galway, Ireland

Location

Letterkenny General Hospital

Letterkenny, Ireland

Location

Mid- Western Regional Hospital

Limerick, Ireland

Location

Sligo General Hospital

Sligo, Ireland

Location

Waterford Regional Hospital

Waterford, Ireland

Location

MeSH Terms

Conditions

Breast NeoplasmsCardiotoxicity

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Ray McDermott, MD

    Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 28, 2009

First Posted

August 31, 2009

Study Start

April 1, 2008

Primary Completion

April 1, 2014

Last Updated

December 31, 2014

Record last verified: 2014-08

Locations

IE(14)