NCT02062983

Brief Summary

Early identification of patients at risk for cardiotoxicity represent a primary goal for cardiologist and oncologist From all adjuvant trials echocardiography is ideal for evaluating Left Ventricular function though its operator dependent. The use of other technique such as endomyocardial biopsy, is troublesome in clinical practice Cardiac magnetic resonance imaging (MRI) have greater reproducibility in evaluating left ventricular ejection fraction (LVEF). This technique provides morphological, functional, perfusion, and viability information in one assessment. It is expensive and time consuming but id the diagnostic method of choice for patients with technically limited images from ECG and in patients with discordant information that is clinically significant from prior tests

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

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

June 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

4.2 years

First QC Date

January 23, 2014

Last Update Submit

May 12, 2016

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Estimate the incidence /of Herceptin induced heart failure in our population

    To evaluate the reversibility of damage in patients on long term follow- up for a period of up to three years. To identify the applicability of troponin / cardiac natriuretic peptides (CNPS) as bio marker that can predict the occurrence of clinically significant left ventricular dysfunction. To evaluate the role of MRI in identifying patient at risk to develop cardio toxicity. Determine the frequency of elevated Troponin and B-type natriuretic peptide (BNP) in patient receiving adjuvant herceptin.

    3 years

Secondary Outcomes (1)

  • Determine the incremental diagnostic value of Trop and BNP in predicting incidence of Hem CMP.

    3 years

Study Arms (1)

Herceptin

The study will be carried in prospective manner enrolling all patients diagnosed with breast cancer and over expressed human epidermal growth factor receptor 2 (HER2) and they are requiring Trastuzumab Neu adjuvant/ adjuvant /metastatic therapy as per standard care.

Drug: Herceptin

Interventions

HerceptinDRUG

Herceptin will be administered in different way per each setting as follow::total herceptin cycles are 18. Neu Adjuvant : chemo+herceptin, Surgery (hold herceptin) , Resume herceptin for 1 year period Adjuvant : Surgery, chemo+herceptin for 1 year period Metastatic : chemo+herceptin until progression.

Herceptin

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pilot study trying to identify early predictor for developing cardiotoxicity in such patients.

You may qualify if:

  • Breast cancer cases with histopathology prove of invasive carcinoma with HER 2 over expression detected by immunochemical stain and/ or FISH.
  • Age 18 to 80 years old. Patient with above criteria and eligible for Neu adjuvant/ adjuvant /metastatic( Trastuzumab) Herceptin therapy.
  • Normal blood count, liver function test and kidney function.

You may not qualify if:

  • Abnormal cardio vascular disease (ex. Heart Failure, Ischemic Heart Disease, post CABG) with EF≤50.
  • Valvular abnormality with reduced ejection fraction (EF). Recent Myocardiac Infraction / Ischemia Pregnancy or Breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Guard Health Affairs

Riyadh, Riyadh Region, 11426, Saudi Arabia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

January 23, 2014

First Posted

February 14, 2014

Study Start

June 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations

SA(1)