Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Breast Cancer (CCT2)

Abramson Cancer Center at Penn Medicine

Status: Active, not recruiting

Conditions: Cardiotoxicity; Breast Cancer; Drug-Related Side Effects and Adverse Reactions; Cardiovascular Diseases

Treatments: Other: Social Determinants of Health

Study type: Observational

Funder types: Other

Identifiers

NCT05078190

UPCC 11121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 3 patient groups

Doxorubicin

Description:

Patients treated with doxorubicin (Adriamycin) for breast cancer

Treatment:

Other: Social Determinants of Health

Trastuzumab

Description:

Patients treated with trastuzumab (Herceptin) for breast cancer

Treatment:

Other: Social Determinants of Health

Doxorubicin and Trastuzumab

Description:

Patients treated with both doxorubicin (Adriamycin) and trastuzumab (Herceptin) for breast cancer

Treatment:

Other: Social Determinants of Health