Recruiting

Trastuzumab

Sponsor:

Unity Health Toronto

Code:

NCT01022086

Conditions

Stage I-IV Breast Cancer (Neo-adjuvant, Adjuvant, Locally Advanced and Metastatic)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cardiac MRI

Biomarker Testing

Study Details

Brief summary:

Herceptin has shown significant improvement in breast cancer therapy and improved survival of patients over-expressing the HER-2 protein by 50%. However, Herceptin has shown to negatively affect the heart, and frequent heart monitoring with multiple gated acquisition (MUGA) scans is required. MUGA scans use radiation and are not very accurate. This study will use cardiac magnetic resonance images (CMRs) to evaluate heart function and compare to MUGA scans in patients receiving Herceptin for early-stage breast cancer. In addition, novel biomarkers will also be assessed at the same time to help identify possible patients at risk for developing heart toxicities.

Conditions

Stage I-IV Breast Cancer (Neo-adjuvant, Adjuvant, Locally Advanced and Metastatic)

Study ID

NCT01022086

Start date

Nov, 2009

Status verified date

Jul, 2017

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Aged 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Histologically confirmed diagnosis of invasive breast carcinoma
  • Histologically confirmed HER2 overexpression using IHC and/or FISH and/or DISH
  • Planned treatment with Trastuzumab or TDM-1
  • Baseline LVEF >50% by MUGA (ECHOs or any other type of cardiac scanning may be done as part of standard clinical care, at the investigator's discretion; ECHOs cannot be done in place of MUGA scans)

Exclusion criteria:

  • Previous treatment with trastuzumab or any other anti-HER2 agent (e.g. lapatinib, pertuzumab, etc.)
  • Pre-existing symptomatic Heart Failure (NYHA Class III or IV)
  • Recent acute coronary syndrome (myocardial infarction, unstable angina) within the last six months
  • Recent coronary revascularization (percutaneous coronary intervention or coronary bypass surgery) within six months
  • Permanent atrial fibrillation
  • Inability to undergo MRI (shrapnel, metallic implants/clips, pacemaker or defibrillator)
  • Currently pregnant and/or nursing
  • Planned or current use of other targeted biological therapies that can potentially cause cardiotoxicity (i.e. bevacizumab)

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

early stage/adjuvant

Analyses will also be stratified according to the patient's stage of disease (i.e. early stage/adjuvant, locally advanced/neoadjuvant, and metastatic) and type of chemotherapy regimen (i.e. anthracycline-containing vs. non-anthracycline).

locally advanced/neoadjuvant

Analyses will also be stratified according to the patient's stage of disease (i.e. early stage/adjuvant, locally advanced/neoadjuvant, and metastatic) and type of chemotherapy regimen (i.e. anthracycline-containing vs. non-anthracycline).

metastatic

Analyses will also be stratified according to the patient's stage of disease (i.e. early stage/adjuvant, locally advanced/neoadjuvant, and metastatic) and type of chemotherapy regimen (i.e. anthracycline-containing vs. non-anthracycline).

anthracycline-containing

Analyses will also be stratified according to the patient's stage of disease (i.e. early stage/adjuvant, locally advanced/neoadjuvant, and metastatic) and type of chemotherapy regimen (i.e. anthracycline-containing vs. non-anthracycline).

non-anthracycline containing

Analyses will also be stratified according to the patient's stage of disease (i.e. early stage/adjuvant, locally advanced/neoadjuvant, and metastatic) and type of chemotherapy regimen (i.e. anthracycline-containing vs. non-anthracycline).

Interventions

Cardiac MRI

Cardiac magnetic resonance (CMR) imaging, otherwise called a cardiac (heart) MRI is a safe and standard clinical test that creates detailed images of your heart. It uses a computer to create images of your heart as it is beating, producing both still and moving pictures of your heart and major blood vessels. This test will allow the health professionals to obtain images of your beating heart and to look at the structure and function. Cardiac MRIs can help diagnose and evaluate a number of diseases conditions (such as heart failure, and heart valve disease) and will help doctors decide how to treat or manage patients who have heart problems.

Biomarker Testing

In addition to undergoing CMR imaging, patients will also have blood tests for two proteins, which serve as markers of heart injury and heart failure. These are called BNP and Troponin. These blood tests are currently used in clinical practice, but their precise role in monitoring heart function in cancer patients has not been well studied. Since the precise cause of Trastuzumab-induced heart damage is currently unknown, it is hoped that these two blood markers will provide valuable insights into how this happens.

Peripheral venous blood samples will also be drawn at each CMR time-point. TGF β1, amino terminal propeptide of procollagen type I (PINP) and type III (PIIINP) and the carboxy-terminal telopeptide of collagen type 1 (CITP) will be measured by radioimmunoassay.

Primary outcome measure

  • To compare CMR with MUGA scans for determining LVEF and LV volumes in breast cancer patients treated with trastuzumab. [ Time Frame: Five years ]

Central Contacts and Locations

Central contacts

Christine B Brezden-Masley, MD, PhD

1-416-864-5734brezdenc@smh.ca

Daisy Dastur, MHSc, CCRP, CCRC

1-416-864-5354dasturd@smh.ca

Locations

Odette Cancer Centre/Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Teresa Petrella, BSc, MD, MSc, FRCPC

416-480-5248Teresa.Petrella@sunnybrook.ca

Kim Connelly, MD FRCPC, FACC

+14168645201connellyk@smh.ca

Principal Investigator:

Teresa Petrella, MD, MSc, FRCPC

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Christine B Brezden-Masley, MD, PhD

1-416-864-5734brezdenc@smh.ca

Daisy Dastur, MHSc. CCRP, CCRC

1-416-864-5354dasturd@smh.ca

Principal Investigator:

Christine B Brezden-Masley, MD, PhD

More Information

Sponsor

Unity Health Toronto

Last update posted

Jul 12, 2017

Last verified

Jul, 2017

Keywords

  • Breast Cancer
  • Cardiotoxicity
  • Trastuzumab
  • Cardiac MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2017-07-12.