CCT2: Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Breast Cancer
Study Details
Study Description
Brief Summary
This is an observational study for patients with breast cancer that will be treated with doxorubicin (Adriamycin) and/or trastuzumab (Herceptin). The study will help the investigators learn more about how these medications affect the heart and how those effects relate to patients' medical history and social determinants of health (such as race, gender identity, education, occupation, access to health services and economic resources). Patients on this study will have echocardiograms, blood draws, and answer questions about their symptoms and activity level. Patients will be followed on this study for up to 15 years.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The investigators propose a prospective longitudinal cohort of breast cancer patients treated with anthracyclines and/or trastuzumab to determine the associations between social determinants of health (SDOH) and cardiotoxicity risk and to determine whether associations between SDOH and cardiotoxicity risk differ according to race. Patients will be followed with serial echo, blood draw, and surveys every 3 months for the first year, then annually for two years. After 3 years following start of cancer therapy, patients will have study visits every other year for up to 15 years.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Doxorubicin Patients treated with doxorubicin (Adriamycin) for breast cancer |
Other: Social Determinants of Health
The study will perform detailed phenotyping of Social Determinants of Health using the National Institute of Minority Health and Health Disparities PhenX SDOH toolkit at baseline.
|
| Trastuzumab Patients treated with trastuzumab (Herceptin) for breast cancer |
Other: Social Determinants of Health
The study will perform detailed phenotyping of Social Determinants of Health using the National Institute of Minority Health and Health Disparities PhenX SDOH toolkit at baseline.
|
| Doxorubicin and Trastuzumab Patients treated with both doxorubicin (Adriamycin) and trastuzumab (Herceptin) for breast cancer |
Other: Social Determinants of Health
The study will perform detailed phenotyping of Social Determinants of Health using the National Institute of Minority Health and Health Disparities PhenX SDOH toolkit at baseline.
|
Outcome Measures
Primary Outcome Measures
- Change in Left Ventricular Ejection Fraction (LVEF) [through study completion (expected to be 15 years)]
Absolute change in LVEF by echocardiogram at follow-up
Secondary Outcome Measures
- Cancer therapy-related cardiac dysfunction (CTRCD) [through study completion (expected to be 15 years)]
Incidence of CTRCD defined as at least a 10% absolute change in LVEF by echocardiogram at follow-up relative to baseline to a value < 50%
- Symptomatic Heart Failure (HF) [through study completion (expected to be 15 years)]
Incidence of symptomatic heart failure (centrally adjudicated)
- Change in Longitudinal Strain [through study completion (expected to be 15 years)]
Change in longitudinal strain by echo from baseline
- Change in Circumferential Strain [through study completion (expected to be 15 years)]
Change in circumferential strain by echo from baseline
- Change in Diastolic function [through study completion (expected to be 15 years)]
Change in diastolic function defined as E/e' by echo from baseline
- Change in Left Ventricular (LV) Mass [through study completion (expected to be 15 years)]
Change in LV Mass by echo from baseline
- Change in Relative LV Wall Thickness [through study completion (expected to be 15 years)]
Change in relative LV wall thickness from baseline
- Change in Ventricular-Arterial Coupling [through study completion (expected to be 15 years)]
Change in Ventricular-Arterial Coupling defined as Ea/Ees by echo from baseline
- Change in LV Twist [through study completion (expected to be 15 years)]
Change in LV Twist measured by 3D echo from baseline
- Change in LV Torsion [through study completion (expected to be 15 years)]
Change in LV Torsion measured by 3D echo from baseline
- Change in NTproBNP [through study completion (expected to be 15 years)]
Change in NTproBNP measured in batches from banked samples from baseline.
- Change in high-sensitivity troponin (hsTnT) [through study completion (expected to be 15 years)]
Change in hs-TnT measured in batches from banked samples from baseline.
- Change in patient reported fatigue [through study completion (expected to be 15 years)]
Change in Patient Reported Outcomes Information System (PROMIS) Fatigue Score from baseline. A higher score corresponds to higher reported levels of fatigue.
- Change in patient reported quality of life [through study completion (expected to be 15 years)]
Change in Patient Reported Outcomes Information System (PROMIS) Global Health score from baseline. Higher scores indicate a healthier patient.
- Change in patient reported activity level [through study completion (expected to be 15 years)]
Change in total weekly leisure activity in METS assessed by Godin Leisure Time Exercise Questionnaire from baseline.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Women older than 18 years of age
-
Breast cancer with treatment plan that includes doxorubicin and/or trastuzumab
-
Ability to provide written informed consent
Exclusion Criteria:
-
Pregnancy at enrollment
-
Inability or unwillingness to provide consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Abramson Cancer Center of the University of Pennsylvania
- American Heart Association
Investigators
- Principal Investigator: Bonnie Ky, MD, MSCE, University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UPCC 11121