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

NCT ID: NCT05078190

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-21

Study Completion Date

2039-10-31

Brief Summary

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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

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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.

Conditions

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

Keywords

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Cardiotoxicity of Chemotherapy Cardio-Oncology Social Determinants of Health

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Doxorubicin

Patients treated with doxorubicin (Adriamycin) for breast cancer

Social Determinants of Health

Intervention Type OTHER

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

Social Determinants of Health

Intervention Type OTHER

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

Social Determinants of Health

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bonnie Ky, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Barrett M, Wilcox NS, Huang A, Levy R, Demissei B, Narayan V, Ky B. Bearing allostatic load: insights into a more equitable future within cardio-oncology. Trends Mol Med. 2022 Dec;28(12):1040-1049. doi: 10.1016/j.molmed.2022.09.006. Epub 2022 Oct 4.

Reference Type DERIVED
PMID: 36207229 (View on PubMed)

Other Identifiers

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UPCC 11121

Identifier Type: -

Identifier Source: org_study_id