Stage I-IV Breast Cancer (Neo-adjuvant, Adjuvant, Locally Advanced and Metastatic) Clinical Trial
Official title:
Assessment of Cardiotoxicity by Cardiac MRI Versus MUGA Scans in Breast Cancer Patients Receiving Trastuzumab: A Double-Blinded Prospective Observational Pilot Study
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Canada | Odette Cancer Centre/Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | St. Michael's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
St. Michael's Hospital, Toronto | Hoffmann-La Roche |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | To determine the long-term prognostic significance of reduced LVEF and myocardial injury detected by CMR and biomarkers in breast cancer patients treated with trastuzumab. | Five years | ||
Primary | To compare CMR with MUGA scans for determining LVEF and LV volumes in breast cancer patients treated with trastuzumab. | Five years | ||
Secondary | To examine the association between changes in biomarker levels and changes in cardiac structure and function as measured by CMR in breast cancer patients receiving trastuzumab. | Five years |