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| ID | Type | Description | Link |
|---|---|---|---|
| R21HL152148 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Investigators will evaluate the safety and feasibility of a biomarker-guided cardioprotection strategy using NTproBNP, as compared to usual care, in breast cancer and lymphoma patients treated with anthracyclines.
This is a randomized, open-label pilot trial of a biomarker-guided strategy using NT-proBNP to identify and treat patients with a high risk of cancer therapy-related cardiotoxicity. Patients will be enrolled and randomized prior to initiation of anthracycline-based therapy and followed for 12 months with blood samples, echocardiography, and patient reported outcomes surveys. The overall hypothesis is that a biomarker guided treatment strategy that initiates neurohormonal antagonists in breast cancer or lymphoma patients who have increases in NT-proBNP prior to, during, or after anthracyclines will be feasible, well-tolerated, and result in attenuation of cardiotoxicity, compared to standard care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biomarker Guided Arm | Experimental | NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. |
|
| Usual Care | No Intervention | NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomarker Guided Intervention | Other | NTproBNP above the upper limit of normal will trigger the initiation of heart failure therapy with counseling from a study investigator based on protocol specified algorithm. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | percent of patients approached about the study who provided consent | At baseline |
| Retention Rate | percent of randomized patients who complete the study per protocol | Through study completion (expected to be 1 year) |
| Compliance Rate | Compliance by Patient Reported Outcomes Information System (PROMIS) Scale v1.0 for patients in the biomarker guided arm initiated on heart failure medications. A higher PROMIS compliance score indicates better compliance with medications (score ranges from 9 - 45). | Through study completion (expected to be 1 year) |
| Maximum Dose | Maximum dose (mg) of neurohormonal antagonist therapy for participants in the intervention arm who initiated neurohormonal therapy for NTproBNP elevation across all study timepoints. Please note, due to numeric validation requirement, the max dose for combination drugs reported below is the max dose for the component in our algorithm (e.g. valsartan-hydrochlorothiazide is reported below as 325, which is the max dose of valsartan). | Through study completion (expected to be 1 year) |
| Incidence of Adverse Events | Number of patients that had at least one targeted AE of grade 3 or higher at any time on study. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NTproBNP | Change in estimated core lab measured NTproBNP by group. GEE model adjusted for baseline values and time since anthracycline initiation, modeled with spline function. NTproBNP is a hormone released when the heart is under stress. Concentrations greater than 125 pg/ml are considered to be elevated. | Through study completion (1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diastolic Function on Echo | GEE model of change in core lab measured E/e'. E/e' is a measure of diastolic function derived from the ratio of the pulse wave Doppler interrogations of the mitral inflow at the mitral valve leaflet tips and at the lateral and septal mitral annulus via tissue Doppler imaging. This measure provided insight into myocardial relaxation, preload, and left ventricular filling pressures, with values > 14 indicative of elevated filling pressure. GEE model is adjusted for baseline values and time since anthracycline initiation, modeled with spline function. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bonnie Ky, MD, MSCE | Perelman School of Medicine at the University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Abramson Cancer Center at University of Pennsylvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41335439 | Derived | Xia C, Smith AM, Lefebvre B, Jamal FA, Armenian SH, Koropeckyj-Cox D, Zhang L, Liu PP, Landsburg D, Clark AS, Shah PD, Hubbard RA, Huang A, Golec S, Hewitt M, Wilcox NS, Chen Z, Rethy L, Jung W, Ko K, Narayan V, Martei YM, Lang NN, Januzzi JL, Felker GM, Ky B. Biomarker-Guided Cardioprotection for Patients Treated With Anthracyclines: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2546201. doi: 10.1001/jamanetworkopen.2025.46201. |
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108 individuals provided consent. 7 individuals were not randomized due to 1 of the following reasons: voluntary withdrawal, change in chemotherapy regimen, or uncontrolled blood pressure. 101 patients were randomized and started the trial.
Enrollment took place from March 2021 to October 2023 from outpatient oncology practices at multiple locations within the University of Pennsylvania Health System and at City of Hope Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Biomarker Guided Arm | NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of anthracycline chemotherapy. |
| FG001 | Usual Care | NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of anthracycline chemotherapy. Biomarker data will also be collected at each cycle of anthracycline chemotherapy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed or data collected, so this individual is not included in the baseline analysis population description.
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| ID | Title | Description |
|---|---|---|
| BG000 | Biomarker Guided Arm | NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Recruitment Rate | percent of patients approached about the study who provided consent | We defined recruitment rate as the percent of patients approached about the study who consented to participate | Posted | Count of Participants | Participants | At baseline |
|
|
From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
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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 | Biomarker Guided Arm | NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE 5.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Kidney Injury | Renal and urinary disorders | CTCAE 5.0 | Systematic Assessment |
Limitations of this study include the relatively small sample size; heterogeneity in study population; the inclusion of patients treated with neurohormonal therapy prior to enrollment which was done to allow a more representative sample; the open-label design (although all outcomes were centrally adjudicated); and a follow-up period of 12 months.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bonnie Ky | Perelman School of Medicine at the University of Pennsylvania | 215-662-7700 | bonnie.ky@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 4, 2023 | Feb 2, 2026 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| D001943 | Breast Neoplasms |
| D008223 | Lymphoma |
| D009202 | Cardiomyopathies |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Serial monitoring of NTproBNP during chemotherapy will be used to identify high-risk patients in the intervention arm; patients who experience elevations in NTproBNP will be initiated and titrated on a personalized regimen of neurohormonal antagonists. Patients in the usual care arm will not have serial NTproBNP monitoring and will be managed according to usual care.
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| Change in Left Ventricular Ejection Fraction (LVEF) | Change in core-lab quantitated LVEF by echocardiogram from baseline. GEE model adjusted for baseline values and time since anthracycline initiation, modeled with spline function. LVEF is a measurement of how much blood the heart pumps out with each beat. It is calculated by dividing the volume of blood ejected with each beat divided the volume of blood in the heart, multiplied by 100 and reported as a percentage. An LVEF of less than 50% is considered abnormal. | 12 months |
| Incidence of Cardiotoxicity | Incidence of cardiotoxicity defined as LVEF decline of at least 10% to less than 50% | 12 months |
| Incidence of Heart Failure (HF) | Incidence of new or worsened clinical heart failure, defined as urgent or new office or emergency department visit or hospitalization for adjudicated heart failure. | 12 months |
| Frequency of Cancer Treatment Interruptions | Frequency of cancer treatment interruptions (holds or early discontinuations) | Through study completion (expected to be 1 year) |
| 12 months |
| Change in Longitudinal Strain | Change in core-lab quantitated estimated global longitudinal strain by echocardiogram. GEE model adjusted for baseline values and time since anthracycline initiation, modeled with spline function. Global longitudinal strain (GLS, %) averaged from 3 apical views (left ventricular apical 4-chamber, 2-chamber, and 3-chamber) was obtained using speckle-tracking technology using Tomtec Imaging Systems. GLS is a more sensitive measure of cardiac function, with values greater than -16% (e.g., -15%) for GLS associated with worse outcomes. | 12 months |
| Change in Circumferential Strain | Change in core-lab measured circumferential strain by echocardiogram. GEE model adjusted for baseline values and time since anthracycline initiation, modeled with spline function. Circumferential strain (%) from the short axis view (mid left ventricle) was obtained using speckle-tracking technology using Tomtec Imaging Systems. Circumferential strain is a more sensitive measure of cardiac function, with values or greater than -20% (e.g., -19%) associated with worse outcomes. | 12 months |
| Patient Reported Fatigue | We utilized the Patient Reported Outcomes Information System (PROMIS) Fatigue T-Score. A PROMIS Fatigue T-score of 50 indicates the population mean with a standard deviation of 10. A higher score corresponds to higher levels of reported fatigue. | 12 months |
| Patient Reported Quality of Life | We utilized the Patient Reported Outcomes Information System (PROMIS) Global Health T-score. PROMIS v1.2 Global Health was used to assess physical and mental health. A T-Score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate better global physical or mental health. | 12 months |
| Patient Reported Symptoms | NCI Patient Reported Outcomes - Common Terms and Criteria for Adverse Events (PRO CTCAE) was used to ascertain presence of 7 symptoms (Shortness of Breath, Cough, Fatigue, Dizziness, Chest Pain, Palpitations, Limb Swelling). | 12 months |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Chester County Hospital | West Chester | Pennsylvania | 19380 | United States |
| BG001 | Usual Care | NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity was self-reported | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race was self-reported | Count of Participants | Participants |
|
| Cancer Type | Count of Participants | Participants |
|
| Systolic Blood Pressure | Median | Inter-Quartile Range | mmHg |
|
| Left Ventricular Ejection Fraction | LVEF is a measurement of how much blood the heart pumps out with each beat. It is calculated by dividing the volume of blood ejected with each beat divided the volume of blood in the heart, multiplied by 100 and reported as a percentage. An LVEF of less than 50% is considered abnormal. LVEF was measured centrally for this trial. | Median | Inter-Quartile Range | % |
|
| Cardiovascular Risk Factors | Count of Participants | Participants |
|
| NTproBNP Concentration | Centrally measured NTproBNP concentration; NTproBNP is a hormone released when the heart is under stress. Concentrations greater than 125 pg/ml are considered to be elevated. | Median | Inter-Quartile Range | pg/ml |
|
| Body Mass Index (BMI) | Median | Inter-Quartile Range | kg/m2 |
|
|
| Primary | Retention Rate | percent of randomized patients who complete the study per protocol | The analysis population for retention rate excludes those patients who died while on study. | Posted | Count of Participants | Participants | Through study completion (expected to be 1 year) |
|
|
|
| Primary | Compliance Rate | Compliance by Patient Reported Outcomes Information System (PROMIS) Scale v1.0 for patients in the biomarker guided arm initiated on heart failure medications. A higher PROMIS compliance score indicates better compliance with medications (score ranges from 9 - 45). | In total, 27 patients on the intervention arm experienced at least 1 NTproBNP elevation. Of these, 4 did not have any initiation or titration of neurohormonal medications at any point. The analysis population for compliance with study medications includes only those patients who initiated or titrated neurohormonal medications for NTproBNP elevation. | Posted | Median | Inter-Quartile Range | score on a scale | Through study completion (expected to be 1 year) |
|
|
|
| Primary | Maximum Dose | Maximum dose (mg) of neurohormonal antagonist therapy for participants in the intervention arm who initiated neurohormonal therapy for NTproBNP elevation across all study timepoints. Please note, due to numeric validation requirement, the max dose for combination drugs reported below is the max dose for the component in our algorithm (e.g. valsartan-hydrochlorothiazide is reported below as 325, which is the max dose of valsartan). | For this outcome measure, we consider only those patients randomized to the intervention arm who initiated and/or titrated at least one neurohormonal therapy for NTproBNP elevation on trial. | Posted | Median | Inter-Quartile Range | mg | Through study completion (expected to be 1 year) |
|
|
|
| Primary | Incidence of Adverse Events | Number of patients that had at least one targeted AE of grade 3 or higher at any time on study. | 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed or data collected, so this individual is not included in the outcome reporting. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Change in NTproBNP | Change in estimated core lab measured NTproBNP by group. GEE model adjusted for baseline values and time since anthracycline initiation, modeled with spline function. NTproBNP is a hormone released when the heart is under stress. Concentrations greater than 125 pg/ml are considered to be elevated. | Randomized participants with baseline and at least one follow-up measure of NTproBNP. | Posted | Least Squares Mean | 95% Confidence Interval | log2 transformed (pg/ml) | Through study completion (1 year) |
|
|
|
|
| Secondary | Change in Left Ventricular Ejection Fraction (LVEF) | Change in core-lab quantitated LVEF by echocardiogram from baseline. GEE model adjusted for baseline values and time since anthracycline initiation, modeled with spline function. LVEF is a measurement of how much blood the heart pumps out with each beat. It is calculated by dividing the volume of blood ejected with each beat divided the volume of blood in the heart, multiplied by 100 and reported as a percentage. An LVEF of less than 50% is considered abnormal. | Patients were included in the echocardiogram analysis if they had a baseline echocardiogram and at least 1 follow-up echocardiogram. | Posted | Least Squares Mean | Inter-Quartile Range | percentage | 12 months |
|
|
|
|
| Secondary | Incidence of Cardiotoxicity | Incidence of cardiotoxicity defined as LVEF decline of at least 10% to less than 50% | Patients were included in analysis if they had a baseline echocardiogram and at least 1 follow-up echocardiogram. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Incidence of Heart Failure (HF) | Incidence of new or worsened clinical heart failure, defined as urgent or new office or emergency department visit or hospitalization for adjudicated heart failure. | 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed or data collected, so this individual is not included in the outcome reporting. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Frequency of Cancer Treatment Interruptions | Frequency of cancer treatment interruptions (holds or early discontinuations) | 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed or data collected, so this individual is not included in the outcome reporting. | Posted | Count of Participants | Participants | Through study completion (expected to be 1 year) |
|
|
|
| Other Pre-specified | Change in Diastolic Function on Echo | GEE model of change in core lab measured E/e'. E/e' is a measure of diastolic function derived from the ratio of the pulse wave Doppler interrogations of the mitral inflow at the mitral valve leaflet tips and at the lateral and septal mitral annulus via tissue Doppler imaging. This measure provided insight into myocardial relaxation, preload, and left ventricular filling pressures, with values > 14 indicative of elevated filling pressure. GEE model is adjusted for baseline values and time since anthracycline initiation, modeled with spline function. | Patients were included in the echocardiogram analysis if they had a baseline echocardiogram and at least 1 follow-up echocardiogram. | Posted | Least Squares Mean | 95% Confidence Interval | ratio | 12 months |
|
|
|
|
| Other Pre-specified | Change in Longitudinal Strain | Change in core-lab quantitated estimated global longitudinal strain by echocardiogram. GEE model adjusted for baseline values and time since anthracycline initiation, modeled with spline function. Global longitudinal strain (GLS, %) averaged from 3 apical views (left ventricular apical 4-chamber, 2-chamber, and 3-chamber) was obtained using speckle-tracking technology using Tomtec Imaging Systems. GLS is a more sensitive measure of cardiac function, with values greater than -16% (e.g., -15%) for GLS associated with worse outcomes. | Patients were included in the echocardiogram analysis if they had a baseline echocardiogram and at least 1 follow-up echocardiogram. | Posted | Least Squares Mean | 95% Confidence Interval | percentage points | 12 months |
|
|
|
|
| Other Pre-specified | Change in Circumferential Strain | Change in core-lab measured circumferential strain by echocardiogram. GEE model adjusted for baseline values and time since anthracycline initiation, modeled with spline function. Circumferential strain (%) from the short axis view (mid left ventricle) was obtained using speckle-tracking technology using Tomtec Imaging Systems. Circumferential strain is a more sensitive measure of cardiac function, with values or greater than -20% (e.g., -19%) associated with worse outcomes. | Patients were included in the echocardiogram analysis if they had a baseline echocardiogram and at least 1 follow-up echocardiogram. | Posted | Least Squares Mean | 95% Confidence Interval | percentage points | 12 months |
|
|
|
|
| Other Pre-specified | Patient Reported Fatigue | We utilized the Patient Reported Outcomes Information System (PROMIS) Fatigue T-Score. A PROMIS Fatigue T-score of 50 indicates the population mean with a standard deviation of 10. A higher score corresponds to higher levels of reported fatigue. | 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed or data collected, so this individual is not included in the outcome reporting. | Posted | Mean | Standard Deviation | T-score | 12 months |
|
|
|
| Other Pre-specified | Patient Reported Quality of Life | We utilized the Patient Reported Outcomes Information System (PROMIS) Global Health T-score. PROMIS v1.2 Global Health was used to assess physical and mental health. A T-Score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate better global physical or mental health. | 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed or data collected, so this individual is not included in the outcome reporting. | Posted | Mean | Standard Deviation | T-score | 12 months |
|
|
|
| Other Pre-specified | Patient Reported Symptoms | NCI Patient Reported Outcomes - Common Terms and Criteria for Adverse Events (PRO CTCAE) was used to ascertain presence of 7 symptoms (Shortness of Breath, Cough, Fatigue, Dizziness, Chest Pain, Palpitations, Limb Swelling). | 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed or data collected, so this individual is not included in the outcome reporting. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 0 |
| 50 |
| 9 |
| 50 |
| 47 |
| 50 |
| EG001 | Usual Care | NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy. | 4 | 50 | 14 | 50 | 46 | 50 |
| Disease Progression | General disorders | CTCAE 5.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE 5.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE 5.0 | Systematic Assessment |
|
| Neutrophil Count Decreased | Blood and lymphatic system disorders | CTCAE 5.0 | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
|
| White blood cell decreased | Blood and lymphatic system disorders | CTCAE 5.0 | Systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | CTCAE 5.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
|
| Dypsnea | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE 5.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
|
| Heart failure | Cardiac disorders | CTCAE 5.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE 5.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE 5.0 | Systematic Assessment |
|
| Left Ventricular Systolic Dysfunction | Cardiac disorders | CTCAE 5.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | PRO CTCAE | Systematic Assessment | Patient reported new or worsened shortness of breath in preceding 7 days during at least one visit on study. |
|
| Cough | Respiratory, thoracic and mediastinal disorders | PRO CTCAE | Systematic Assessment | Patient reported new or worsened cough in preceding 7 days during at least one visit on study |
|
| Fatigue | General disorders | PRO CTCAE | Systematic Assessment | Patient reported new or worsened fatigue during preceding 7 days during at least one visit on study |
|
| Dizziness | Nervous system disorders | PRO CTCAE | Systematic Assessment | Patient reported new or worsened dizziness in preceding 7 days during at least 1 visit on study. |
|
| Chest Pain | Cardiac disorders | PRO CTCAE | Systematic Assessment | Patient reported new or worsened chest pain in preceding 7 days during at least one visit on study |
|
| Palpitations | Cardiac disorders | PRO CTCAE | Systematic Assessment | Patient reported new or worsened pounding or racing heartbeat in preceding 7 days during at least one visit on study |
|
| Limb Edema | Vascular disorders | PRO CTCAE | Systematic Assessment | Patient reported new or worsened arm or leg swelling in preceding 7 days during at least one visit on study. |
|
Not provided
Not provided
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| 6 months |
|
| 9 months |
|
| 12 months |
|
| 9 month |
|
| 12 month |
|
| 9 months |
|
| 12 months |
|
| 9 months |
|
| 12 months |
|
| 9 months |
|
| 12 months |
|
| 6 Months |
|
| 9 Months |
|
| 12 Months |
|
| Mental Health 6 Months |
|
| Mental Health 9 Months |
|
| Mental Health 12 Months |
|
| Physical Health Baseline |
|
| Physical Health 3 Months |
|
| Physical Health 9 Months |
|
| Physical Health 12 Months |
|
| 6 Months - Shortness of Breath |
|
| 9 Months - Shortness of Breath |
|
| 12 Months - Shortness of Breath |
|
| Baseline - Cough |
|
| 3 Months - Cough |
|
| 6 Months - Cough |
|
| 9 Months - Cough |
|
| 12 Months - Cough |
|
| Baseline - Fatigue |
|
| 3 Months - Fatigue |
|
| 6 Months - Fatigue |
|
| 9 Months - Fatigue |
|
| 12 Months - Fatigue |
|
| Baseline - Dizziness |
|
| 3 Months - Dizziness |
|
| 6 Months - Dizziness |
|
| 9 Months - Dizziness |
|
| 12 Months - Dizziness |
|
| Baseline - Chest Pain |
|
| 3 Months - Chest Pain |
|
| 6 Months - Chest Pain |
|
| 9 Months - Chest Pain |
|
| 12 Months - Chest Pain |
|
| Baseline - Palpitations |
|
| 3 Months - Palpitations |
|
| 6 Months - Palpitations |
|
| 9 Months - Palpitations |
|
| 12 Months - Palpitations |
|
| Baseline - Swelling in Arms/Legs |
|
| 3 Months - Swelling in Arms/Legs |
|
| 6 Months - Swelling in Arms/Legs |
|
| 9 Months - Swelling in Arms/Legs |
|
| 12 Months - Swelling in Arms/Legs |
|