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Several large adjuvant trastuzumab trials have demonstrated improved overall survival in participants with early stage breast cancer, with a 33% decrease in risk of death. However, retrospective analyses of participant outcomes in these trials have demonstrated increased risk of cardiotoxicity (i.e damage to the heart) in a small number of patients (4-8%).
At this time, investigators are unable to predict which participants are at increased risk of cardiac-related treatment complications. Currently all patients receive regular cardiac imaging throughout their one year of trastuzumab treatment.
At this time, the optimal monitoring schedule for trastuzumab-related cardiotoxicity remains unknown, and several published consensus guidelines are currently in use as standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LVEF 3 month | Active Comparator | cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months |
|
| LVEF 4 month | Active Comparator | cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LVEF 3 month | Procedure | cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| LVEF Results | Changes in Left Ventricular Ejection Fraction (LVEF) results compared to baseline (by echocardiography or MUGA) throughout the course of trastuzumab based therapy. LVEF is measured as a percentage. The outcome is a change in LVEF percentage (%). | Baseline to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Trastuzumab Delay and Discontinuation | The number of participants who had a delay and/or discontinuation in trastuzumab treatment. Data was collected from physicians following clinic visits and from patient electronic medical records. | 1 year |
| Referral to Cardiology |
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Inclusion Criteria:
Exclusion Criteria:
• Contraindication to transthoracic echocardiography or MUGA
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| Name | Affiliation | Role |
|---|---|---|
| Olexiy Aseyey, MD | The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southlake Regional Health Centre | Newmarket | Ontario | L3Y 2P9 | Canada | ||
| The Ottawa Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34940066 | Result | Dent S, Fergusson D, Aseyev O, Stober C, Pond G, Awan AA, McGee SF, Ng TL, Simos D, Vandermeer L, Saunders D, Hilton JF, Hutton B, Clemons M. A Randomized Trial Comparing 3- versus 4-Monthly Cardiac Monitoring in Patients Receiving Trastuzumab-Based Chemotherapy for Early Breast Cancer. Curr Oncol. 2021 Dec 3;28(6):5073-5083. doi: 10.3390/curroncol28060427. |
| Label | URL |
|---|---|
| Rethinking Clinical Trials (REaCT) Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | LVEF 3 Month | cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months LVEF 3 month: cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months |
| FG001 | LVEF 4 Month |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Per Protocol Population |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 13, 2018 |
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| LVEF 4 month | Procedure | cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months |
|
The number of participants who were referred to cardiology. Data was collected from physicians following clinic visits, and from the patient's electronic medical record. |
| 1 year |
| Rate of Cardiac Events | The number of participants who experienced a decrease in ejection fraction (EF), congestive heart failure, or other cardiac events within the 1 year of study. Examples of other cardiac events include change in blood pressure, chest pain/shortness of breath, or irregular heartbeat. Data was collected/reported from physicians following clinic appointments, and from the patient's electronic medical record. | 1 year |
| Ottawa |
| Ontario |
| K1H 8L6 |
| Canada |
| The Ottawa Hospital Cancer Centre | Ottawa | Ontario | K2H 8L6 | Canada |
| Thunder Bay Regional Health Sciences Centre | Thunder Bay | Ontario | P7B 6V4 | Canada |
cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months
LVEF 4 month: cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months
| COMPLETED |
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| NOT COMPLETED |
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| Completed Study as Planned |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | LVEF 3 Month | cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months LVEF 3 month: cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months |
| BG001 | LVEF 4 Month | cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months LVEF 4 month: cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Baseline Left Ventricular Ejection Fraction (LVEF) | Baseline LVEF measured by echocardiogram or MUGA and reported as a percentage | Median | Full Range | LVEF Percentage (%) |
| ||||||||||||||
| Anthracycline-based chemotherapy | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | LVEF Results | Changes in Left Ventricular Ejection Fraction (LVEF) results compared to baseline (by echocardiography or MUGA) throughout the course of trastuzumab based therapy. LVEF is measured as a percentage. The outcome is a change in LVEF percentage (%). | Per Protocol Population | Posted | Median | Full Range | LVEF Percentage (%) | Baseline to 1 year |
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| Secondary | Rates of Trastuzumab Delay and Discontinuation | The number of participants who had a delay and/or discontinuation in trastuzumab treatment. Data was collected from physicians following clinic visits and from patient electronic medical records. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Referral to Cardiology | The number of participants who were referred to cardiology. Data was collected from physicians following clinic visits, and from the patient's electronic medical record. | Posted | Count of Participants | Participants | 1 year |
|
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| Secondary | Rate of Cardiac Events | The number of participants who experienced a decrease in ejection fraction (EF), congestive heart failure, or other cardiac events within the 1 year of study. Examples of other cardiac events include change in blood pressure, chest pain/shortness of breath, or irregular heartbeat. Data was collected/reported from physicians following clinic appointments, and from the patient's electronic medical record. | Posted | Count of Participants | Participants | 1 year |
|
|
All-cause mortality was monitored for 12 months.
Serious adverse event reporting was not required for this study, as per the protocol. This was a pragmatic clinical trial comparing two standard of care schedules of cardiac monitoring, not treatments. Cardiac adverse events were collected and reported as secondary clinical outcomes. They were not collected/reported as adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LVEF 3 Month | cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months LVEF 3 month: cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months | 0 | 98 | 0 | 0 | 0 | 0 |
| EG001 | LVEF 4 Month | cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months LVEF 4 month: cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months | 0 | 97 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Hilton | Ottawa Hospital Research Institute | 613-737-7700 | 70170 | jfhilton@toh.ca |
| Mar 31, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D066126 | Cardiotoxicity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
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| Metastatic disease |
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