Studie van cardiopulmonale inspanningstesten bij vrouwen met HER2-positieve borstkanker met milde cardiotoxiciteit
Een pilootstudie van cardiopulmonale inspanningstesten bij patiënten met linkerventrikelsystolische disfunctie die HER2-gerichte therapie krijgen
The purpose of this study is to find out how much oxygen is used during a cardiopulmonary exercise test (CPET) in women who have mild cardiotoxicity after standard treatment for HER2-positive breast cancer, and to see whether the results of this test can be used to predict how well participants' heart and lungs will work if they continue to receive this kind of treatment.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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New York
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New York, New York, Verenigde Staten, 10021
- Memorial Sloan - Kettering Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Potential research participants will be identified by a member of the participant's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering Cancer Center (MSK). If the investigator is a member of the treatment team, s/he will screen their potential participant's medical records for suitable research study participants and discuss with the subject their potential for enrolling in the research study.
Beschrijving
Inclusion Criteria:
- Age ≥ 18 years
- Female
- Diagnosed with a HER2-positive solid tumor (stage I-IV)
- Left ventricular dysfunction prior to the start of HER2-targeted therapy, defined by a LVEF < 53% (or lower limit of normal), or diagnosed with mild cardiotoxicity associated with HER2-targeted therapy, defined by an absolute decrease in LVEF ≥ 10% from pre-treatment to < 53%
- Planning to undergo treatment with HER2-targeted therapy (e.g. trastuzumab, pertuzumab, or ado-trastuzumab) for a minimum of 3 months (i.e. 4 cycles administered every 3 weeks).
- Willing and able to comply with the requirements of the protocol
Exclusion Criteria:
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Symptomatic heart failure (New York Heart Association Class III or IV)
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Subjects must not have any of the following absolute contraindications to cardiopulmonary exercise testing:
- Acute myocardial infarction (within 30 days of any planned study procedures),
- Unstable angina
- Uncontrolled arrhythmias causing symptoms or hemodynamic compromise,
- Symptomatic severe aortic stenosis
- Recurrent syncope
- Active endocarditis
- Acute myocarditis or pericarditis
- Acute pulmonary embolus or pulmonary infarction (within 3 months of any planned study procedures)
- Thrombosis of lower extremities (within 3 months of any planned study procedures)
- Suspected dissecting aneurysm
- Uncontrolled asthma
- Pulmonary edema
- Room air desaturation at rest ≤ 85%
- Respiratory failure
- Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)
- Mental impairment leading to inability to cooperate.
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Enrollment onto any other interventional investigational study
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Inability to provide informed consent
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Participants with HER2-positive breast cancer
Participants with HER2-positive breast cancer who have developed mild cardiotoxicity during HER2-targeted therapy, defined by a decline in LVEF > 10% to < 53% without symptoms of clinical heart failure (NYHA class III or IV), will be eligible for participation in this study. |
All enrolled participants will undergo a cardiopulmonary exercise test (CPET). The CPET will be conducted using an electronic motorized treadmill with 12-lead ECG monitoring performed by ACSM-certified exercise physiologists.
Andere namen:
Resting assessment of LVEF and GLS will be evaluated through Conventional 2D and Doppler echocardiograms will be performed per protocol using a commercially available ultrasound scanner, according to the American Society of Echocardiography (ASE) recommendations for a comprehensive examination. As soon as possible following completion of the CPET, subjects will be placed in the supine position and 2D echocardiographic images will be obtained in the apical 4-/ 3-/2-chamber views. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Baseline VO2peak in participants with HER2-positive breast cancer
Tijdsspanne: At baseline
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The primary purpose is to evaluate baseline VO2peak in patients with HER2-positive solid tumors and left ventricular systolic dysfunction |
At baseline
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Anthony Yu, MD, Memorial Sloan Kettering Cancer Center
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Hart-en vaatziekten
- Wonden en verwondingen
- Pathologische processen
- Neoplasmata per site
- Neoplasmata
- Hartziekten
- Chemisch veroorzaakte aandoeningen
- Huidziektes
- Borst ziekten
- Geneesmiddelgerelateerde bijwerkingen en bijwerkingen
- Stralingsverwondingen
- Pathologische aandoeningen, tekenen en symptomen
- Huid- en bindweefselaandoeningen
- Borstneoplasmata
- Cardiotoxiciteit
- Onderzoekstechnieken
- Diagnostische technieken en procedures
- Diagnose
- Diagnostische beeldvorming
- Diagnostische technieken, ademhalingssysteem
- Diagnostische technieken, cardiovasculair
- Hartfunctietests
- Ademhalingsfunctietests
- Ergometrie
- Cardiale beeldvormingstechnieken
- Ultrasonografie
- Trainingstest
- Echocardiografie
Andere studie-ID-nummers
- 21-271
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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