Clinical trial NCT05078190: Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Breast Cancer
Official title: Cardiotoxicity of Cancer Therapy 2: Mechanisms, Predictors, and Social Determinants of Health in Breast Cancer Patients Treated with Doxorubicin And/or Trastuzumab
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Cardiotoxicity
Drug-Related Side Effects and Adverse Reactions
Cardiovascular Diseases
Keywords: Cardiotoxicity of Chemotherapy
Cardio-Oncology
Social Determinants of Health
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2021-10-14
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the medical oncology practices at the Abramson Cancer Center.

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Left Ventricular Ejection Fraction (LVEF)
timeFrame: through study completion (expected to be 15 years)
Secondary outcomes:
measure: Cancer therapy-related cardiac dysfunction (CTRCD)
timeFrame: through study completion (expected to be 15 years)
measure: Symptomatic Heart Failure (HF)
timeFrame: through study completion (expected to be 15 years)
measure: Change in Longitudinal Strain
timeFrame: through study completion (expected to be 15 years)
measure: Change in Circumferential Strain
timeFrame: through study completion (expected to be 15 years)
measure: Change in Diastolic function
timeFrame: through study completion (expected to be 15 years)
measure: Change in Left Ventricular (LV) Mass
timeFrame: through study completion (expected to be 15 years)
measure: Change in Relative LV Wall Thickness
timeFrame: through study completion (expected to be 15 years)
measure: Change in Ventricular-Arterial Coupling
timeFrame: through study completion (expected to be 15 years)
measure: Change in LV Twist
timeFrame: through study completion (expected to be 15 years)
measure: Change in LV Torsion
timeFrame: through study completion (expected to be 15 years)
measure: Change in NTproBNP
timeFrame: through study completion (expected to be 15 years)
measure: Change in high-sensitivity troponin (hsTnT)
timeFrame: through study completion (expected to be 15 years)
measure: Change in patient reported fatigue
timeFrame: through study completion (expected to be 15 years)
measure: Change in patient reported quality of life
timeFrame: through study completion (expected to be 15 years)
measure: Change in patient reported activity level
timeFrame: through study completion (expected to be 15 years)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Bonnie Ky, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: