Clinical trial · Observational
Side Effects Involving the Heart in Women With Breast Cancer Receiving Doxorubicin and Trastuzumab
Predicting Adverse Cardiac Events in Breast Cancer Therapy (PACE in Breast Cancer)
NCT00875238CI-TRIAL-00031712PACE in BCcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Studying samples of blood and tissue in the laboratory from women receiving doxorubicin and trastuzumab for breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers for increased risk of cardiac effects. PURPOSE: This clinical trial is studying side effects involving the heart in women with breast cancer receiving doxorubicin and trastuzumab.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cardiac Toxicity | — | UNRESOLVED | — |
| Cardiovascular Complications | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
| polymorphism analysis | Genetic | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| trastuzumab | Biological | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in cardiac function by echocardiogram
- timeFrame
- 5 years
- description
- change in cardiac function as measured by serial echocardiograms
Secondary outcomes (1)
- measure
- Overall feasibility
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosed with breast cancer * Receiving treatment at Vanderbilt Ingram Cancer Center and other participating oncology practices in middle Tennessee and southern Kentucky * Starting a standard doxorubicin hydrochloride regimen for 4 courses * Also scheduled to receive trastuzumab (for patients enrolled in sub-study B only) * No presence of metastatic disease * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * Karnofsky performance status 60-100% * Not pregnant * Negative pregnancy test * Additional criteria for sub-study A (MRI): * Glomerular filtration rate ≥ 60 mL/min * No implanted electronic devices, cochlear implants, metallic implants, shrapnel or neurosurgical clips * No prior adverse reaction to gadolinium-based contrast agents * Must not exceed the weight limit or be too large to fit in the MRI scanner PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior anthracycline chemotherapy
References
Publications (2)
- RESULTGeisberg CA, Abdallah WM, da Silva M, Silverstein C, Smith HM, Abramson V, Mayer I, Means-Powell J, Freehardt D, White B, Lenihan D, Sawyer DB. Circulating neuregulin during the transition from stage A to stage B/C heart failure in a breast cancer cohort. J Card Fail. 2013 Jan;19(1):10-5. doi: 10.1016/j.cardfail.2012.11.006. PMID 23273589
- DERIVEDLenneman CG, Abdallah WM, Smith HM, Abramson V, Mayer IA, Silverstein C, Silverstein C, Means-Powell J, Paranjape SY, Lenihan D, Sawyer DB, Raj SR. Sympathetic nervous system alterations with HER2+ antagonism: an early marker of cardiac dysfunction with breast cancer treatment? Ecancermedicalscience. 2014 Jul 17;8:446. doi: 10.3332/ecancer.2014.446. eCollection 2014. PMID 25114718