[c09aa8]: / clusters / 9knumclustersv2 / clust_920.txt

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Left ventricular ejection fraction (LVEF) assessment must be performed within days prior to randomization; (LVEF assessment performed by -dimensional [D] echocardiogram is preferred; however, multi gated acquisition [MUGA] scan may be substituted based on institutional preferences;) the LVEF must be >= % regardless of the cardiac imaging facility's lower limit of normal
Patients with a history of LVEF decline to below % during or after prior trastuzumab or other HER directed therapy
Patients with cardiomyopathy and/or LVEF < LLN.
LVEF < % during previous trastuzumab therapy
LVEF assessment must be performed within days prior to randomization. (LVEF assessment performed by echocardiogram is preferred; however, MUGA scan may be substituted based on institutional preferences.) The LVEF must be ? % regardless of the cardiac imaging facility's lower limit of normal.
Testing for LVEF is not required for pre-registration, but patient must not have a recent LVEF < LLN or have symptoms of congestive heart failure
PART II: Baseline LVEF by D echocardiogram >= %
Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) of ? % as assessed by echocardiogram or MUGA scan, or LVEF of -% and clearance by a cardiologist; if subject receives cardiotoxic chemotherapy after enrollment, repeat echocardiogram or MUGA is required to reestablish eligible LVEF
Left Ventricular Ejection Fraction (LVEF) < %, or a history of clinically significant decrease in LVEF during previous treatment with trastuzumab or (ado-)trastuzumab emtansine;
Patients with LVEF =< % from treatment with anthracyclines for all malignancies at any dose without evidence of other causes of cardiomyopathy
LVEF < % and >= % documented in echocardiogram done within the last days
Abnormal LVEF (< LLN for the institution for a patient of that age) on echocardiogram
Normal EKG and LVEF >%, measured by EKG and MUGA scan, radionuclide ventriculogram, or echocardiogram
Left ventricular ejection fraction (LVEF) assessment must be performed within weeks prior to randomization; (LVEF assessment performed by echocardiogram is preferred; however, multigated acquisition scan (MUGA) scan may be substituted based on institutional preferences); the LVEF must be >= % regardless of the cardiac imaging facility's lower limit of normal
History of asymptomatic LVEF decline to < % during or after prior HER-targeted therapy
LVEF < LLN on screening exam
Patients with LVEF =< % documented from treatment with anthracyclines for any malignancy at any dose at any time without evidence of other causes of cardiomyopathy
Left ventricular ejection fraction (LVEF) assessment (eg, echocardiogram, radionuclide ventriculogram scan [MUGA], first-pass technique) performed within months prior to initiation of study treatment indicates an LVEF of >= %
Left ventricular ejection fraction (LVEF) assessment must be performed within days prior to randomization; (LVEF assessment performed by -dimensional [-D] echocardiogram is preferred; however, multi gated acquisition scan [MUGA] scan may be substituted based on institutional preferences); the LVEF must be >= % regardless of the cardiac imaging facility's lower limit of normal; note: since the pre-entry LVEF serves as the baseline for comparing subsequent LVEF assessments, it is critical that this baseline study be an accurate assessment; if the baseline LVEF is > %, the investigator is encouraged to have the accuracy of the initial LVEF result confirmed and repeat the test if the accuracy is uncertain
LVEF at least %
LVEF < %
Screening Left ventricular ejection fraction (LVEF) >/= % on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than % absolute points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >/= % after completion of neoadjuvant chemotherapy.
LVEF < % by echocardiogram
Patients with a history of LVEF decline to below % during or after prior trastuzumab/lapatinib or other HER directed therapy.
LVEF >= % at rest (by ECHO)
LVEF < % as determined by echocardiogram performed at screening or within days prior to CD
Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by echocardiogram (ECHO); multigated acquisition (MUGA) scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive (LVEF of > % required if normal range LVEF is not provided by institution)
LVEF
History of absolute decrease in LVEF of ? absolute percentage points, or ? absolute percentage points and crossing from > LLN to < LLN on prior anti-HER therapy, even if asymptomatic and the LVEF decrease recovered;
Serious myocardial dysfunction defined as ultrasound-determined LVEF < % of predicted institutional normal value.
History of a decrease in LVEF to < % or symptomatic CHF with previous trastuzumab treatment
LVEF < LLN for the institution
LVEF (measured by Echocardiogram) > %
LVEF of at least %
If previously measured, known LVEF < %
LVEF >%, or an LVEF within the normal limits of the institution's specific testing (MUGA or ECHO)
Documented normal LVEF for at least months after the initiation of recommended HF therapy