Breast Cancer Clinical Trial
Official title:
Use of Novel Biomarkers and Echocardiography to Assess Subclinical Cardiac Toxicity in Breast Cancer Patients Receiving Anthracyclines
This is a pilot prospective cohort study, in adult female subjects 18-85 years old with a diagnosis of invasive breast cancer who are planned for anthracycline-inclusive chemotherapy and followed up for a time period of 6 months post completion of anthracycline chemotherapy. They will participate in blood and imaging tests with a goal of determining the best method for predicting the occurrence of cardiotoxicity in this subpopulation.
Anthracyclines and other chemotherapy agents are associated with cardiotoxicity. The risk of
cardiac related toxicity is increased in patients with advanced age, with multiple comorbid
conditions, and those needing prolonged or intensive treatment. These patients require a
tailored approach to surveillance, early diagnosis and treatment of cardiac issues related to
cancer therapy, with timely decision making with respect to alterations in therapy. A serum
biomarker approach alone or in combination with imaging indices holds promise for early
identification, risk stratification and monitoring of chemotherapy related cardiotoxicity.
Thirty-five consecutive adult females between the ages of 18-85 with diagnosis of invasive
breast cancer, planned for anthracycline inclusive chemotherapy (+/- taxanes, +/-
trastuzumab) will be enrolled.
A detailed medical history (interim where appropriate), physical exam, collection of blood
samples for the measurement of Heart Failure (HF) biomarkers (and standard chemistry and
hematology parameters), electrocardiogram and a 2D/3D echo cardiogram including the
measurement of global longitudinal strain will be performed at baseline, mid chemotherapy, at
the end of chemotherapy and 6 months post the completion of chemotherapy. (echocardiogram
will not be done during chemotherapy).
The hypothesis being tested in this prospective trial is whether early changes in the levels
of serum biomarkers of stress (N terminal pro B-type natriuretic peptide (NT-proBNP)),
inflammation (ST2), necrosis (hs troponin), and fibrosis (galectin-3) will correlate with
changes in sub-clinical left ventricular dysfunction as assessed by 3-dimensional (3D)
echocardiogram with speckle tracking/strain in breast cancer patients receiving anthracycline
based chemotherapy.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
| Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
| Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
| Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
| Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
| Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
| Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
| Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
| Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
| Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
| Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
| Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
| Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
| Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
| Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
| Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
| Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
| Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
| Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 |