Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Breast Cancer

Breast Cancer Clinical Trial

— CCT2  

Official title:

Cardiotoxicity of Cancer Therapy 2: Mechanisms, Predictors, and Social Determinants of Health in Breast Cancer Patients Treated With Doxorubicin and/or Trastuzumab

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05078190
• Other study ID #: UPCC 11121
• Status: Recruiting
• Start date: October 21, 2021
• Est. completion date: October 2039

Study information

• Verified date: February 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Bonnie Ky, MD, MSCE
• Phone: 215-573-6606
• Email: bonnie.ky[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2039
• Est. primary completion date: October 2039
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cardiotoxicity
• Cardiovascular Diseases
• Drug-Related Side Effects and Adverse Reactions

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Left Ventricular Ejection Fraction (LVEF)	Absolute change in LVEF by echocardiogram at follow-up	through study completion (expected to be 15 years)
Secondary	Cancer therapy-related cardiac dysfunction (CTRCD)	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%	through study completion (expected to be 15 years)
Secondary	Symptomatic Heart Failure (HF)	Incidence of symptomatic heart failure (centrally adjudicated)	through study completion (expected to be 15 years)
Secondary	Change in Longitudinal Strain	Change in longitudinal strain by echo from baseline	through study completion (expected to be 15 years)
Secondary	Change in Circumferential Strain	Change in circumferential strain by echo from baseline	through study completion (expected to be 15 years)
Secondary	Change in Diastolic function	Change in diastolic function defined as E/e' by echo from baseline	through study completion (expected to be 15 years)
Secondary	Change in Left Ventricular (LV) Mass	Change in LV Mass by echo from baseline	through study completion (expected to be 15 years)
Secondary	Change in Relative LV Wall Thickness	Change in relative LV wall thickness from baseline	through study completion (expected to be 15 years)
Secondary	Change in Ventricular-Arterial Coupling	Change in Ventricular-Arterial Coupling defined as Ea/Ees by echo from baseline	through study completion (expected to be 15 years)
Secondary	Change in LV Twist	Change in LV Twist measured by 3D echo from baseline	through study completion (expected to be 15 years)
Secondary	Change in LV Torsion	Change in LV Torsion measured by 3D echo from baseline	through study completion (expected to be 15 years)
Secondary	Change in NTproBNP	Change in NTproBNP measured in batches from banked samples from baseline.	through study completion (expected to be 15 years)
Secondary	Change in high-sensitivity troponin (hsTnT)	Change in hs-TnT measured in batches from banked samples from baseline.	through study completion (expected to be 15 years)
Secondary	Change in patient reported fatigue	Change in Patient Reported Outcomes Information System (PROMIS) Fatigue Score from baseline. A higher score corresponds to higher reported levels of fatigue.	through study completion (expected to be 15 years)
Secondary	Change in patient reported quality of life	Change in Patient Reported Outcomes Information System (PROMIS) Global Health score from baseline. Higher scores indicate a healthier patient.	through study completion (expected to be 15 years)
Secondary	Change in patient reported activity level	Change in total weekly leisure activity in METS assessed by Godin Leisure Time Exercise Questionnaire from baseline.	through study completion (expected to be 15 years)