Clinical trial · Interventional
Understanding and Predicting Breast Cancer Events After Treatment
Understanding and Predicting Breast Cancer Events After Treatment (UPBEAT)
NCT02791581CI-TRIAL-00096884UPBEATactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
This study is being done to see if patients receiving chemotherapy for breast cancer affects the heart, the ability to exercise and fatigue when compared to patients who do not have cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiac MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Breast Cancer Patients
- description
- Breast cancer patients receiving non-anthracycline or anthracycline chemotherapy Cardiac MRIs will be performed baseline, 3 months (for cancer patients only), and 24 months. Baseline: Collect innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, on 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers. Measurements will be repeated at 3±1, 12±2 and 24±2 months after initiation of chemotherapy treatment.
- interventionNames
- Diagnostic Test: Cardiac MRI
- type
- EXPERIMENTAL
- label
- Non-Cancer Controls
- description
- Non-Cancer Controls Cardiac MRIs will be performed baseline and 24 months. Baseline: Collect innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers. Measurements will be repeated at 3±1, 12±2 (after the completion of radiation) and 24±2 months after initiation of baseline activities.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for Women with Stage I - III Breast Cancer: * Stage I-III female breast cancer (including inflammatory and newly diagnosed or locally recurrent breast cancer) but not metastatic breast cancer being treated with curative intent * \> 18 years old * Scheduled to receive chemotherapy and/or estrogen antagonist aromatase inhibitors (anastrozole \[Arimidex\], letrozole \[Femara\], exemestane \[Aromasin\]). * Able to hold breath for 10 seconds * ECOG performance status 0 -2 * Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting * Able to exercise on a treadmill or stationary cycle * Participants in other ongoing clinical trials are eligible for this study Exclusion Criteria for Women with Stage I-III Breast Cancer: * Those with ferromagnetic cerebral aneurysm clips or other intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices (patients with tissue expanders will not be excluded) * If previously measured, known LVEF \<50% * Symptomatic claustrophobia * Unable to provide informed consent * At the beginning of the study, pregnant women and women who are breast-feeding will not be enrolled. * Severe pulmonary hypertension * Within the past 6 months: * Acute pulmonary embolus * Deep vein thrombosis * Within the past month: * Heart attack * Unstable or stable angina (cardiac chest pain) * Left main coronary artery disease * Symptomatic heart failure * Uncontrolled hypertension (SBP \> 180 mm Hg or DBP \> 120 mm Hg) * Severe valvular heart disease * Uncontrolled metabolic disease (diabetes with fasting BS \>300 mg/dl, thyrotoxicosis, myxedema) * Aortic aneurism (\>45 mm diameter) or aortic dissection * Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise * Hypertrophic obstructive cardiomyopathy * Patient does not understand English Inclusion Criteria for Women Free of Cancer for Comparison: * Healthy female without known coronary artery disease \> 18 years old * Able to hold breath 10 seconds * ECOG performance status = 0 or 1 * Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting * Able to exercise on a treadmill or stationary cycle * No personal history of cancer other than superficial skin cancers * Has never received chemotherapy, radiation therapy, immunotherapy, or had breast cancer related surgery * If previously measured, LVEF ≥ 50% Exclusion Criteria for Women Free of Cancer for Comparison: * Inflammatory conditions such as lupus or inflammatory bowel disease * Overt coronary artery disease or heart failure * Those with ferromagnetic cerebral aneurysm clips or other intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices * Symptomatic claustrophobia * Unable to provide informed consent * At the beginning of the study, pregnant women or women who are breast feeding will not be enrolled. * Severe pulmonary hypertension * Within the past 6 months: * Acute pulmonary embolus * Deep vein thrombosis * Within the past month: * Heart attack * Unstable or stable angina (cardiac chest pain) * Left main coronary artery disease * Symptomatic heart failure * Uncontrolled hypertension (SBP \> 180 mm Hg or DBP \> 120 mm Hg) * Severe valvular heart disease * Uncontrolled metabolic disease (diabetes with fasting BS \>300 mg/dl, thyrotoxicosis, myxedema) * Aortic aneurism (\>45 mm diameter) or aortic dissection * Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise * Hypertrophic obstructive cardiomyopathy * Patient does not understand English
References
Publications (5)
- DERIVEDAvis NE, O'Connell NS, Mihalko SL, Jordan JH, Ladd AC, Lesser GJ, Olson KC, Weaver KE, Dressler EV, Grizzard PJ, Levine B, Moore TL, Ky B, Hackney MH, Brubaker P, Reding KW, Lucas AR, Bellissimo MP, Moeller FG, Kitzman DW, Hamilton CA, Klepin HD, Yeboah J, Ntim W, Zaha VG, D'Agostino R Jr, Hundley WG. Long-Term Fatigue After Treatment for Breast Cancer. JAMA Netw Open. 2026 Aug 3;9(8):e2629862. doi: 10.1001/jamanetworkopen.2026.29862. PMID 42611514
- DERIVEDMabudian L, Reding K, D'Agostino RB Jr, Heiston EM, Bellissimo MP, Olson K, Ntim WO, Klepin HD, Dressler EV, Moore T, Jordan JH, O'Connell NS, Ladd A, Weaver KE, Ky B, Wagner LI, Hackney MH, Lesser GJ, Hundley WG; UPBEAT Study Team. The relationship between body composition and left ventricular performance in women with breast, lymphoma, or sarcoma cancer. Cardiooncology. 2024 Jun 6;10(1):34. doi: 10.1186/s40959-024-00233-1. PMID 38845066
- DERIVEDGarg R, D'Agostino RB Jr, O'Connell N, Lesser GJ, Salloum FN, Hines AL, Melendez GC, Jordan JH, Ky B, Wagner LI, Sutton AL, Bottinor W, Olson KC, Ladd AC, Hundley WG; UPBEAT Study Team. Hypertension Severity and Declines in Left Ventricular Ejection Fraction Among Women Receiving Adjuvant Chemotherapy for Breast Cancer (WF-97415 UPBEAT). Hypertension. 2024 Jun;81(6):1365-1373. doi: 10.1161/HYPERTENSIONAHA.123.21817. Epub 2024 Apr 18. PMID 38634292
- DERIVEDBellissimo MP, Canada JM, Jordan JH, Ladd AC, Reding KW, Moore TL, Ntim WO, Heiston EM, Brubaker P, Mihalko SL, D'Agostino R Jr, O'Connell N, Ky B, Wagner LI, Hackney MH, Weaver KE, Lesser GJ, Avis NE, Sutton AL, Lucas AR, Franco RL, Fuemmeler BF, Salloum FN, Hundley WG; UPBEAT Study Group. Physical Activity During Breast Cancer Therapy Associates With Preserved Exercise Capacity and Cardiac Function (WF97415). JACC CardioOncol. 2023 Mar 21;5(5):641-652. doi: 10.1016/j.jaccao.2022.12.011. eCollection 2023 Oct. PMID 37969655
- DERIVEDBellissimo MP, Canada JM, Jordan JH, Ladd AC, Heiston EM, Brubaker P, Mihalko SL, Reding K, D Agostino R, O Connell N, Hackney MH, Weaver KE, Lesser GJ, Avis NE, Hundley WG. Changes in Physical Activity, Functional Capacity, and Cardiac Function during Breast Cancer Therapy. Cancer Epidemiol Biomarkers Prev. 2022 Jul 1;31(7):1509. doi: 10.1158/1055-9965.EPI-22-0470.