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NCT Number: NCT05078190

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Social Determinants of Health

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.

Primary outcomes

  1. Change in Left Ventricular Ejection Fraction (LVEF)

    Time frame: through study completion (expected to be 15 years)

    Absolute change in LVEF by echocardiogram at follow-up

Secondary outcomes

  1. Cancer therapy-related cardiac dysfunction (CTRCD)

    Time frame: 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%

  2. Symptomatic Heart Failure (HF)

    Time frame: through study completion (expected to be 15 years)

    Incidence of symptomatic heart failure (centrally adjudicated)

  3. Change in Longitudinal Strain

    Time frame: through study completion (expected to be 15 years)

    Change in longitudinal strain by echo from baseline

  4. Change in Circumferential Strain

    Time frame: through study completion (expected to be 15 years)

    Change in circumferential strain by echo from baseline

  5. Change in Diastolic function

    Time frame: through study completion (expected to be 15 years)

    Change in diastolic function defined as E/e' by echo from baseline

  6. Change in Left Ventricular (LV) Mass

    Time frame: through study completion (expected to be 15 years)

    Change in LV Mass by echo from baseline

  7. Change in Relative LV Wall Thickness

    Time frame: through study completion (expected to be 15 years)

    Change in relative LV wall thickness from baseline

  8. Change in Ventricular-Arterial Coupling

    Time frame: through study completion (expected to be 15 years)

    Change in Ventricular-Arterial Coupling defined as Ea/Ees by echo from baseline

  9. Change in LV Twist

    Time frame: through study completion (expected to be 15 years)

    Change in LV Twist measured by 3D echo from baseline

  10. Change in LV Torsion

    Time frame: through study completion (expected to be 15 years)

    Change in LV Torsion measured by 3D echo from baseline

  11. Change in NTproBNP

    Time frame: through study completion (expected to be 15 years)

    Change in NTproBNP measured in batches from banked samples from baseline.

  12. Change in high-sensitivity troponin (hsTnT)

    Time frame: through study completion (expected to be 15 years)

    Change in hs-TnT measured in batches from banked samples from baseline.

  13. Change in patient reported fatigue

    Time frame: 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.

  14. Change in patient reported quality of life

    Time frame: 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.

  15. Change in patient reported activity level

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • American Heart Association

Registry information

Official study title

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

Acronym: CCT2

Important dates

Study start
2021
Primary completion
2039
Study completion
2039
First posted
Oct 14, 2021
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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