CADY Study ICORG 08-01

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00968682
First received: August 28, 2009
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Cardiac Toxicity
Biological: trastuzumab
Other: laboratory biomarker analysis
Procedure: assessment of therapy complications

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Cardiac Dysfunction in Patients Treated With Trastuzumab for HER-2 Positive Breast Cancer. The CADY Study

Resource links provided by NLM:


Further study details as provided by ICORG- All Ireland Cooperative Oncology Research Group:

Primary Outcome Measures:
  • Cardiac biomarker levels in predicting cardiac dysfunction [ Time Frame: End of trial ] [ Designated as safety issue: No ]
  • Development of a predictive model for use based on the most accurate and sensitive combination of biomarkers [ Time Frame: End of trial ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: April 2008
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To prospectively evaluate whether an increase in cardiac biomarker levels can predict cardiac dysfunction in women with HER2/neu-positive breast cancer treated with trastuzumab as curative intent.

Secondary

  • To develop a predictive model for use in this patient population based on the most accurate and sensitive combination of biomarkers.

This is an observational study with all patients having

  • Blood tests for BNP, Nt-pro BNP, CRP and Troponin-T every 42 days (6 weeks) whilst on treatment with chemotherapy and/or Trastuzumab.
  • Echocardiograph or MUGA before treatment, after completion of anthracycline therapy where applicable, and every twelve weeks whilst on Trastuzumab. Assessment of ejection fraction may be carried out at any time for symptoms. All Echocardiographs and MUGAs will be carried out locally. 2-D Echocardiograph is the preferred method for assessment of LVEF. Where possible, the same cardiac imaging facility should be used for all LVEF assessments. A sample study from each participating institution will be reviewed by the principal investigating cardiologist. Results of left ventricular function assessment will be used to make treatment decisions as normal. Managing clinicians will not be made aware of the results of biomarker assessments, thus this study is blinded.
  • Cardiorespiratory symptom assessment, ECOG score, vitals, weight and NYHA (if applicable) prior to each dose of anthracyclines and every 6 weeks whilst on Paclitaxel-trastuzumab and on single agent Trastuzumab.

Patients on BETH :

The LVEF monitoring sequence required by CADY will be altered to parallel that required by BETH. Thus, echocardiograph or MUGA will be carried out according to the BETH cardiac safety monitoring protocol. This altered schedule applies only to patients enrolled in both studies. Of note, for patients on the BETH study, all LVEF assessments must be performed by the same method used at baseline.

Patients on ALTTO:

It is possible that a patient who is enrolled on both CADY and ALLTO may not eventually receive Trastuzumab. Nonetheless, as Lapatinib is also associated with a risk of cardiotoxicity, such patients should remain on study whilst receiving single agent Lapatinib. The schedule of on study assessments will be identical to that of patients receiving Trastuzumab.

For patients enrolled in both studies, the LVEF monitoring sequence required by CADY will be altered to parallel that required by ALLTO. Thus, echocardiograph or MUGA will be carried out according to the ALLTO cardiac safety monitoring protocol Of note, for patients on the ALLTO study, all LVEF assessments must be performed by the same method used at baseline.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Criteria

Inclusion Criteria

  1. HER-2 positive breast cancer by immunohistochemistry and/or fluorescence in-situ hybridisation.
  2. Planned neoadjuvant and/or adjuvant treatment with chemotherapy and Trastuzumab either sequentially or in combination or single agent Trastuzumab.
  3. 18 years of age or older.
  4. Disease Stage I-III, whose treatment plan includes Trastuzumab either sequentially, in combination or as a single agent will be eligible for inclusion in the study.
  5. As this is a non-interventional study, patients enrolled in therapeutic clinical trials will also be eligible for inclusion.
  6. Treatment with curative intent.
  7. ECOG Performance status 0, 1 or 2.
  8. Adequate cardiac function, with MUGA or Echocardiograph > 50%.
  9. Written informed consent.

Exclusion Criteria:

  1. 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.
  2. Evidence of metastatic disease.
  3. 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.
  4. Prior anthracycline or Trastuzumab therapy.
  5. Inability to give informed consent for any reason.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968682

Locations
Ireland
Bons Secours Hospital
Cork, Ireland
Cork University Hospital
Cork, Ireland
Our Ladies of Lourdes Hospital
Drogheda, Ireland
Mater Private Hospital
Dublin, Ireland
Beaumont Hospital
Dublin, Ireland, 9
Mater Misericordiae University Hospital
Dublin, Ireland, 7
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, Ireland, 24
St. James's Hospital
Dublin, Ireland, 8
St. Vincent's University Hospital
Dublin, Ireland, 4
University College Hospital
Galway, Ireland
Letterkenny General Hospital
Letterkenny, Ireland
Mid- Western Regional Hospital
Limerick, Ireland
Sligo General Hospital
Sligo, Ireland
Waterford Regional Hospital
Waterford, Ireland
Sponsors and Collaborators
ICORG- All Ireland Cooperative Oncology Research Group
Investigators
Principal Investigator: Ray McDermott, MD Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier: NCT00968682     History of Changes
Other Study ID Numbers: CDR0000644153, ICORG-08-01, EU-20948
Study First Received: August 28, 2009
Last Updated: August 11, 2014
Health Authority: Ireland: Health Information and Quality Authority

Keywords provided by ICORG- All Ireland Cooperative Oncology Research Group:
cardiac toxicity
HER2-positive breast cancer
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 25, 2014