NCT05078190

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
163mo left

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Oct 2021Oct 2039

First Submitted

Initial submission to the registry

October 12, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

October 21, 2021

Completed
18 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2039

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2039

Last Updated

November 6, 2025

Status Verified

November 1, 2025

Enrollment Period

18 years

First QC Date

October 12, 2021

Last Update Submit

November 5, 2025

Conditions

Breast CancerCardiotoxicityDrug-Related Side Effects and Adverse ReactionsCardiovascular Diseases

Keywords

Cardiotoxicity of ChemotherapyCardio-OncologySocial Determinants of Health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • Cancer therapy-related cardiac dysfunction (CTRCD)

    through study completion (expected to be 15 years)

  • Symptomatic Heart Failure (HF)

    through study completion (expected to be 15 years)

  • Change in Longitudinal Strain

    through study completion (expected to be 15 years)

  • Change in Circumferential Strain

    through study completion (expected to be 15 years)

  • Change in Diastolic function

    through study completion (expected to be 15 years)

  • +10 more secondary outcomes

Study Arms (3)

Doxorubicin

Patients treated with doxorubicin (Adriamycin) for breast cancer

Other: Social Determinants of Health

Trastuzumab

Patients treated with trastuzumab (Herceptin) for breast cancer

Other: Social Determinants of Health

Doxorubicin and Trastuzumab

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

Other: Social Determinants of Health

Interventions

Social Determinants of HealthOTHER

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.

DoxorubicinDoxorubicin and TrastuzumabTrastuzumab

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited from the medical oncology practices at the Abramson Cancer Center.

You may qualify if:

  • Women older than 18 years of age
  • Breast cancer with treatment plan that includes doxorubicin and/or trastuzumab
  • Ability to provide written informed consent

You may not qualify if:

  • Pregnancy at enrollment
  • Inability or unwillingness to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 36207229DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum, and buffy coat will be banked.

MeSH Terms

Conditions

Breast NeoplasmsCardiotoxicityDrug-Related Side Effects and Adverse ReactionsCardiovascular Diseases

Interventions

Social Determinants of Health

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Health StatusDemographyPopulation CharacteristicsHealth

Study Officials

  • Bonnie Ky, MD, MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2021

First Posted

October 14, 2021

Study Start

October 21, 2021

Primary Completion (Estimated)

October 1, 2039

Study Completion (Estimated)

October 1, 2039

Last Updated

November 6, 2025

Record last verified: 2025-11

Locations

US(1)