Breast Cancer Clinical Trial
Official title:
Early Predictor of Herceptin Cardio Toxicity in Breast Cancer Patients
Early identification of patients at risk for cardiotoxicity represent a primary goal for
cardiologist and oncologist
From all adjuvant trials echocardiography is ideal for evaluating Left Ventricular function
though its operator dependent. The use of other technique such as endomyocardial biopsy, is
troublesome in clinical practice
Cardiac magnetic resonance imaging (MRI) have greater reproducibility in evaluating left
ventricular ejection fraction (LVEF). This technique provides morphological, functional,
perfusion, and viability information in one assessment. It is expensive and time consuming
but id the diagnostic method of choice for patients with technically limited images from ECG
and in patients with discordant information that is clinically significant from prior tests
Current standard of care for patients while on adjuvant trastuzumab is baseline ECHO are as
follows:
Patients on one of the above medications should undergo regular monitoring of the heart
function during treatment as the following:
1. Baseline evaluation of LVEF prior inhibitor of therapy
2. Serial assessment of LVEF using the same modality.
There is no clear international guidelines on the frequency and method of LVEF assessment.
Cardiac function is usually measured by using (ECHO) echo cardiography and multiple-gated
acquisition (MUGA) The patient should be assessed with the same techniques during treatment
to avoid stressing the myocardium by the use of exercise or ionotropic agent, before
measuring LVEF to prevent earlier evidence of cardiotoxicity. Changes in the early atrial
(E/A) filling ratio reflect ventricular compliance and may predict diastolic dysfunction and
so decline in LVEF.
Diastolic dysfunction seems to be predictive of cardiac morbidity and mortality.
Trials with adjuvant trastuzumab use the rules for stopping cardiotoxic agents. They
identified subset of high risk patients by one or two of the following three criteria:
1. A decline with 10% or more in absolute LVEF from a normal base line to 50% or less
2. a high cumulative dose of Doxorubicin ( > 450 mg/m2 ) and / or;
3. abnormal baseline LVEF < 50% Patients who stopped taking doxorubicin after an LVEF
decline were less likely to develop congestive heart failure (CHF) than those who did
not.
Echocardiography is used regularly to monitor LVEF and is more widely available. The MUGA,
in addition it does not expose patients to ionizing radiation but it is operator-dependent
but training and use of automation may overcome the variation .
;
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
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
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
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 |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
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 |