Breast CancerCCT2NCT05078190
Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Breast Cancer
An observational study of Breast Cancer and Cardiotoxicity, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Cardiotoxicity, Drug-Related Side Effects and Adverse Reactions
- What is being tested?
- Social Determinants of Health
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2021to Oct 2039
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from the medical oncology practices at the Abramson Cancer Center.
Who may be able to join
- Women older than 18 years of age
- Breast cancer with treatment plan that includes doxorubicin and/or trastuzumab
- Ability to provide written informed consent
Who cannot join
- Pregnancy at enrollment
- Inability or unwillingness to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Cardiotoxicity of Cancer Therapy 2: Mechanisms, Predictors, and Social Determinants of Health in Breast Cancer Patients Treated With Doxorubicin and/or Trastuzumab
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.
Read the detailed 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.
- Conditions
- Breast Cancer, Cardiotoxicity, Drug-Related Side Effects and Adverse Reactions, Cardiovascular Diseases
- Being tested
- Social Determinants of Health
- Keywords
- Cardiotoxicity of Chemotherapy, Cardio-Oncology, Social Determinants of Health
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity, Drug-Related Side Effects and Adverse Reactions, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Doxorubicin | Patients treated with doxorubicin (Adriamycin) for breast cancer Receives: Other: Social Determinants of Health | |
| Trastuzumab | Patients treated with trastuzumab (Herceptin) for breast cancer Receives: Other: Social Determinants of Health | |
| Doxorubicin and Trastuzumab | Patients treated with both doxorubicin (Adriamycin) and trastuzumab (Herceptin) for breast cancer Receives: Other: Social Determinants of Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular Ejection Fraction (LVEF)
Absolute change in LVEF by echocardiogram at follow-up
Measured: through study completion (expected to be 15 years)
Secondary outcomes (15)
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%
Measured: through study completion (expected to be 15 years)
Symptomatic Heart Failure (HF)
Incidence of symptomatic heart failure (centrally adjudicated)
Measured: through study completion (expected to be 15 years)
Change in Longitudinal Strain
Change in longitudinal strain by echo from baseline
Measured: through study completion (expected to be 15 years)
Change in Circumferential Strain
Change in circumferential strain by echo from baseline
Measured: through study completion (expected to be 15 years)
Change in Diastolic function
Change in diastolic function defined as E/e' by echo from baseline
Measured: through study completion (expected to be 15 years)
Change in Left Ventricular (LV) Mass
Change in LV Mass by echo from baseline
Measured: through study completion (expected to be 15 years)
Change in Relative LV Wall Thickness
Change in relative LV wall thickness from baseline
Measured: through study completion (expected to be 15 years)
Change in Ventricular-Arterial Coupling
Change in Ventricular-Arterial Coupling defined as Ea/Ees by echo from baseline
Measured: through study completion (expected to be 15 years)
Change in LV Twist
Change in LV Twist measured by 3D echo from baseline
Measured: through study completion (expected to be 15 years)
Change in LV Torsion
Change in LV Torsion measured by 3D echo from baseline
Measured: through study completion (expected to be 15 years)
Change in NTproBNP
Change in NTproBNP measured in batches from banked samples from baseline.
Measured: through study completion (expected to be 15 years)
Change in high-sensitivity troponin (hsTnT)
Change in hs-TnT measured in batches from banked samples from baseline.
Measured: through study completion (expected to be 15 years)
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.
Measured: through study completion (expected to be 15 years)
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.
Measured: through study completion (expected to be 15 years)
Change in patient reported activity level
Change in total weekly leisure activity in METS assessed by Godin Leisure Time Exercise Questionnaire from baseline.
Measured: through study completion (expected to be 15 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start21 Oct 2021
- Primary completionOct 2039 (estimated)
- Study completionOct 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Bonnie Ky, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078190
- Sponsor's protocol ID
- UPCC 11121
- Acronym
- CCT2
- Status last verified
- Nov 2025
- First submitted
- 12 Oct 2021
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36207229
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiotoxicity of Cancer Therapy 2: Mechanisms, Predictors, and Social Determinants of Health in Breast Cancer Patients Treated With Doxorubicin and/or Trastuzumab
- ClinicalTrials.gov ID
- NCT05078190
- Acronym / sponsor ID
- CCT2 / UPCC 11121
- Conditions
- Breast Cancer, Cardiotoxicity, Drug-Related Side Effects and Adverse Reactions, Cardiovascular Diseases
- Keywords
- Cardiotoxicity of Chemotherapy, Cardio-Oncology, Social Determinants of Health
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- Oct 2039 (estimated)
- Study completion
- Oct 2039 (estimated)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Doxorubicin | – | Other: Social Determinants of HealthPatients treated with doxorubicin (Adriamycin) for breast cancer |
| Trastuzumab | – | Other: Social Determinants of HealthPatients treated with trastuzumab (Herceptin) for breast cancer |
| Doxorubicin and Trastuzumab | – | Other: Social Determinants of HealthPatients treated with both doxorubicin (Adriamycin) and trastuzumab (Herceptin) for breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the medical oncology practices at the Abramson Cancer Center.
Key inclusion criteria (3 listed)
- Women older than 18 years of age
- Breast cancer with treatment plan that includes doxorubicin and/or trastuzumab
- Ability to provide written informed consent
Key exclusion criteria (2 listed)
- Pregnancy at enrollment
- Inability or unwillingness to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Determinants of HealthThe 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. | Other | Doxorubicin, Doxorubicin and Trastuzumab, Trastuzumab |
Primary outcome
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
15 secondary outcomes
Cancer therapy-related cardiac dysfunction (CTRCD)
Time frame: through study completion (expected to be 15 years)
Symptomatic Heart Failure (HF)
Time frame: through study completion (expected to be 15 years)
Change in Longitudinal Strain
Time frame: through study completion (expected to be 15 years)
Change in Circumferential Strain
Time frame: through study completion (expected to be 15 years)
Change in Diastolic function
Time frame: through study completion (expected to be 15 years)
Change in Left Ventricular (LV) Mass
Time frame: through study completion (expected to be 15 years)
Change in Relative LV Wall Thickness
Time frame: through study completion (expected to be 15 years)
Change in Ventricular-Arterial Coupling
Time frame: through study completion (expected to be 15 years)
Change in LV Twist
Time frame: through study completion (expected to be 15 years)
Change in LV Torsion
Time frame: through study completion (expected to be 15 years)
Change in NTproBNP
Time frame: through study completion (expected to be 15 years)
Change in high-sensitivity troponin (hsTnT)
Time frame: through study completion (expected to be 15 years)
Change in patient reported fatigue
Time frame: through study completion (expected to be 15 years)
Change in patient reported quality of life
Time frame: through study completion (expected to be 15 years)
Change in patient reported activity level
Time frame: through study completion (expected to be 15 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Derived from this study: PubMed 36207229Barrett 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.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bonnie Ky, MD, MSCE principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Cardiotoxicity, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular Ejection Fraction (LVEF) (time frame: through study completion (expected to be 15 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05078190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.