HER  status: tumors must be HER negative defined as HER  or + by immunohistochemical (IHC) assays and/or lack of gene amplification by fluorescence in situ hybridization (FISH) defined as a ratio <  on invasive tumor; a tumor is considered HER+ if + by IHC or ISH amplified >= .
Her- negative, defined as:\r\n* In-situ hybridization (ISH) ratio of < . (if performed)\r\n* Immunohistochemistry (IHC) staining of - positive (+) (if performed) \r\n* Deemed to not be a candidate for Her- directed therapy
Patients must have histologically confirmed mantle cell lymphoma, with cyclin D by immunohistochemical stains and/or t(;) by cytogenetics or fluorescence in situ hybridization (FISH) and with proliferation rate determination, using Ki- or MIB- immunohistochemistry (=< % versus > % versus indeterminate Ki- index)
Patients must have constitutional trisomy  (Down syndrome) or trisomy  mosaicism (by karyotype or fluorescence in situ hybridization [FISH])
Newly diagnosed de novo ALL (B-ALL or T-ALL) with definitive evidence of BCR-ABL fusion by karyotype, fluorescence in situ hybridization (FISH) and/or reverse transcriptase (RT)-PCR
HER-overexpressing breast cancer (+ staining by immunohistochemistry or HER gene amplification by fluorescent in situ hybridization [FISH] or silver in situ hybridization [SISH] >= .)
Pathologically confirmed mantle cell lymphoma (MCL) which is relapsed or refractory to at least one chemotherapy containing regimen\r\n* Presence of cyclin D expression and/or t(;) by fluorescence in situ hybridization (FISH) or cytogenetics is required
Participants must have histologically confirmed HER+ invasive breast cancer (immunohistochemistry [IHC] + and/or fluorescence in situ hybridization [FISH] positive [HER/chromosome  centromere [CEP] >=  and/or >  HER gene copies per nucleus]); note: central confirmation of HER status is not required
Known positivity for HER (as defined by a positive IHC test of + or IHC of _ with fluorescent in situ hybridization [FISH])
To qualify for Part , the participant must be t(;) positive as determined by an analytically validated Fluorescent In Situ Hybridization (FISH) assay per central laboratory testing.
Histologically confirmed HER-positive metastatic breast cancer (HER- + by immunohistochemistry); if immunohistochemistry (IHC) score of , fluorescence in situ hybridization (FISH) ratio must be greater than .; if FISH less than ., HER copy number must be greater than ; NOTE: Brain lesions are not required to have pathologic confirmation; estrogen receptor (ER)-positive patients are allowed
Patients must harbor a tumor HER/neu+ based upon IHC staining score of + or + with confirmed gene amplification by fluorescence in situ hybridization (FISH) to be included
Patients may have any of the following:\r\n* Myc-overexpression (> %) by immunohistochemistry (IHC)\r\n* Myc-amplification (>  copies), as determined by fluorescent in-situ hybridization (FISH)\r\n* MYC-rearrangement, as determined by FISH
Primary and/or metastatic breast tumor must be negative for human epidermal growth factor receptor (HER-/neu) over-expression based on immunohistochemistry (IHC) ( or +, + if fluorescence in-situ hybridization [FISH] test is negative) or FISH (HER/copy number of centromere of chromosome  [CEP] ratio < . or <  Her-/neu signals per nucleus)
HER negative in the primary tumor as defined by:\r\n* Grade  or + staining intensity (on a scale of  to ) by means of immunohistochemistry (IHC) analysis OR\r\n* Grade + staining intensity by means of IHC analysis with gene amplification on fluorescence in situ hybridization (FISH) < . OR\r\n* Gene amplification on fluorescence in situ hybridization (FISH) < .
Tumor positive or negative for expression of hormone receptors (< % or > %) and overexpressing HER by immunohistochemistry (IHC) (+), or, HER-amplified by fluorescence in situ hybridization (FISH) or by alternative gene testing
Negative for HER amplification by in situ hybridization (ISH) for + IHC disease.
Patients must have histologically confirmed, relapsed/refractory ALK+ ALCL (with ALK positivity defined by immunohistochemistry and/or fluorescence in situ hybridization [FISH]/cytogenetics from any prior biopsy), MCL, or BCL+ DLBCL (with BCL positivity defined by immunohistochemistry from any prior biopsy) and meet the following criteria:
Histologically or cytologically confirmed HER-negative ( or + by immunohistochemistry [IHC] or non-amplified by fluorescent in situ hybridization [FISH]) breast cancer that is stage IV
In situ hybridization negative based on:
For subjects with MCL (confirmed with cyclin D expression or evidence of t(;) by cytogenetics, fluorescent in situ hybridization (FISH) or PCR): relapsed or refractory disease after at least  prior regimen with chemo-immunotherapy (prior auto-HSCT is allowable)
Patients must have a diagnosis of mantle cell lymphoma confirmed at diagnosis by one of the following:\r\n* t(;) detected by fluorescence in situ hybridization (FISH), conventional cytogenetics, or other molecular evaluation\r\n* Expression of cyclin D confirmed by immunohistochemistry
Phase II: Patients must have histologically or cytologically confirmed adenocarcinoma of the breast associated with the following clinical stage: IIB, IIIA, IIIB, or IIIC (see AJCC staging criteria, th edition); the tumor must be human epidermal growth factor receptor  (Her)/neu negative (by DAKO HercepTest, fluorescence based in situ hybridization [FISH], or other approved assay)
Tumor negative for expression of hormone receptors (< %) and not over-expressing HER by immunohistochemistry (IHC) (-), or in case of IHC of , negative by fluorescence in situ hybridization (FISH) or by alternative gene testing
INCLUSION - ENROLLMENT: Her- + or fluorescence in situ hybridization (FISH) ratio of . or higher, background gene expression with normal copy number
Cohort #: histologic confirmation of relapsed or relapsed/refractory MCL confirmed by presence of cyclin D by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)
Human epidermal growth factor receptor  (HER) negative by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) staining  or + according to National Comprehensive Cancer Network (NCCN) guidelines
History of biopsy-proven HER-overexpressing breast cancer and radiographic evidence of metastatic disease, or locally recurrent unresectable disease; the HER status can be determined either by immunohistochemistry (IHC) (IHC score, +) or by fluorescence in situ hybridization (FISH) (as defined by HER/CEP- ratio >= ., or HER copy number >= ); patients must have received prior trastuzumab, independent of response to prior trastuzumab, and a taxane (in any disease setting, e.g. neo-adjuvant, adjuvant, metastatic)
Patients must have HER status determined by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC); HER status of positive or negative are both eligible for the study
Positive for HPV by p immunohistochemistry (IHC) or in situ hybridization (ISH).
Histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC) (stage IV, American Joint Committee on Cancer [AJCC] v.) that carries an ALK rearrangement, as determined by the Food and Drug Administration (FDA)-approved fluorescence in situ hybridization (FISH) test, using Vysis ALK Break apart FISH Probe, or the Ventana immunohistochemistry (IHC) test; diagnosis using next generation sequencing (NGS) via a local diagnostic test will be accepted for enrollment but will need to be confirmed with either FISH or IHC
HER negative by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) staining  or +
Patients must have histologically confirmed HER-negative breast cancer (defined as immunohistochemistry [IHC]  or + and/or fluorescence in situ hybridization [FISH] < .), that is metastatic in stage
Must be negative for Her- amplification; (either + on semi-quantitative evaluation of immunostain or negative by fluorescent in-situ hybridization)
Subjects must not have amplification of Her- (either + by semi-quantitative immunostain or positive by fluorescent in-situ hybridization [FISH])
MCL cohort: MCL (diagnosis must be confirmed with cyclin D expression or evidence of t(;) by cytogenetics, fluorescent in situ hybridization [FISH], or PCR) with relapsed or refractory disease after at least  prior line of MCL therapy
Human epidermal growth factor receptor  (HER)-negative breast cancer defined as a negative in situ hybridization test or an IHC status of , + or +; if IHC is + (i.e. indeterminate), a negative in situ hybridization (fluorescence in situ hybridization [FISH], chromogenic in situ hybridization [CISH], or silver in situ hybridization [SISH]) test is required by local laboratory testing; (as per the ASCO-CAP guidelines)
Patients must have an ongoing complete cytogenetic response (CCyR) on a TKI (imatinib, dasatinib, nilotinib, or bosutinib), defined as follows:\r\n* % Ph+ cells in metaphase, in the bone marrow and/or a negative peripheral blood fluorescence in situ hybridization (FISH) analysis for BCR-ABL gene fusion
Is HER normal, defined as HER  or + by immunohistochemistry (IHC) and negative by fluorescence in situ hybridization (FISH) if performed; or HER is + by IHC and negative by FISH; or HER negative by FISH if IHC is not performed.
Patient has HER-negative breast cancer defined as a negative in situ hybridization test or an IHC status of , + or +. If IHC is +, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
Patients must have a metastatic tumor negative for HER; the lack of HER overexpression by immunohistochemistry (IHC), is defined as  or + whereas hyperexpression is defined as +; if equivocal IHC, +, the tumor must be non-gene amplified by fluorescence in situ hybridization (FISH) performed upon the primary tumor or metastatic lesion (ratio <  and HER copy number < )
Patients must have negative HER expression on immunohistochemistry (IHC) (defined as  or +) or fluorescence in situ hybridization (FISH) analysis; if HER is +, negative HER expression must be confirmed by FISH (HER/cep ration < , and/or copy number less than ); ER and PgR expression should be less than %
The current cancer must over express HER as determined by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)
Histologically confirmed adenocarcinoma of the breast that is Her negative (by DAKO Herceptest, fluorescence in situ hybridization [FISH], or other approved assay)
To fulfill the requirement of HER- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER by either IHC or in-situ hybridization (ISH) as defined in the relevant ASCO/CAP or local guidelines.
HER-negative breast cancer based on local laboratory results (test to be used as per local practice); HER-negative tumor is determined as immunohistochemistry score /+ or negative by in situ hybridization (fluorescence in situ hybridization [FISH]/chromogenic in situ hybridization [CISH]/silver-enhanced in situ hybridization [SISH]) defined as a HER/CEP ratio <  or for single probe assessment a HER copy number < 
The invasive cancer must be HER-low, defined as immunohistochemistry (IHC) -+, or with a fluorescence in situ hybridization (FISH) ratio of < . if IHC is + or if IHC has not been performed
Documented human epidermal growth factor receptor  (HER)-negative tumor based on local testing on most recent tumor biopsy: HER-negative tumor is determined as immunohistochemistry score /+ or negative by in situ hybridization (fluorescence in situ hybridization [FISH]/chromogenic in situ hybridization [CISH]/silver in situ hybridization [SISH]) defined as a HER/centromeric probe for chromosome  (CEP) ratio <  or for single probe assessment a HER copy number < 
For Cohort  (subjects with relapsed/refractory synovial sarcoma only), the following tests must be available by local laboratory: Morphology consistent with synovial sarcomas, and cytogenetics or fluorescence in situ hybridization (FISH) and/or molecular confirmation (e.g., DNA sequencing) of SS rearrangement t(X;)(p;q)
For phase II: ER negative (defined as expression of ER in =< % cells), PR negative (defined as expression of PR in =< % cells), HER negative (acceptable methods of HER analysis include IHC [, +], fluorescence in situ hybridization [FISH] with HER/centromere on chromosome  [CEN] ratio < , and/or chromogenic in situ hybridization [CISH] with HER/CEN- ratio < ), as previously documented by histological analysis
Human epidermal growth factor receptor  (HER) negative by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) staining  or +
Is HER normal, defined as HER  or + by immunohistochemistry (IHC) and negative by fluorescence in situ hybridization (FISH) if performed; or HER is + by IHC and negative by FISH; or HER negative by FISH if IHC is not performed
Human epidermal growth factor receptor (HER)  negative defined as  or + using IHC or a ratio of less than . on fluorescence in situ hybridization (FISH) testing; HER  of + on IHC should have a ratio of less than . on FISH testing to be considered HER negative
Human epidermal receptor  (HER) negative by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) staining  or +
Human epidermal growth factor receptor  (HER) negative by fluorescent in situ hybridization (FISH) or immunohistochemistry (IHC) staining  or +
HER positive breast cancer, defined by immunohistochemical staining for HER protein of + intensity and/or amplification of the HER gene on fluorescence in situ hybridization (FISH) >= . on breast specimen or biopsy of a metastatic site
HER overexpression of tumor by either immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH); tumors tested by IHC must be + positive; tumors tested by FISH must have a ratio of HER:CEP > .; when both tests are performed, the FISH result must be positive
Diagnosis of multiple myeloma (MM) with deletion p (delp) or monosomy  by fluorescence in situ hybridization (FISH) who have received at least one line of therapy
Bone marrow analysis demonstrating normal cytogenetics, and no more than % of cells with a single clonal abnormality by fluorescence in situ hybridization (FISH) for myelodysplastic syndrome (MDS) panel within  months of stem cell collection
Multiple myeloma (MM): patients who\r\n* Have received induction therapy for a minimum of  cycles\r\n* In addition, patients must meet at least one of the following criteria I-IX (I-VII at time of diagnosis or pre-autograft): \r\n** Any abnormal karyotype by metaphase analysis except for isolated t(,),\r\n** Fluorescent in situ hybridization (FISH) translocation :,\r\n** FISH translocation :,\r\n** FISH deletion p,\r\n** Beta (B)-microglobulin > . mg/ml,\r\n** Cytogenetic hypodiploidy\r\n** Plasmablastic morphology (>= %)\r\n** Recurrent or non-responsive (less than partial remission [PR]) MM after at least two different lines of conventional chemotherapy\r\n** Progressive MM after a previous autograft (provided stored autologous cluster of differentiation [CD] cells are available)
Patients with histologically confirmed adenocarcinoma of the breast that does not over-express HER-/neu; this is defined as fluorescent in situ hybridization (FISH) negative, or , + or + by immunohistochemistry (IHC); IHC + tumors must be FISH negative with an amplification ratio of less than .; patients must not be eligible for therapy of known curative potential for metastatic breast cancer if it is identified during the course of the study
Must have MLL gene rearrangements documented by split-signal fluorescence in situ hybridization and meets  of the following risk criteria:
Expansion cohort only: Plasma cell fluorescence in situ hybridization (FISH) test demonstrating presence of t(;)
HER overexpression by immunohistocytochemistry (IHC) of + or +, in the primary tumor or metastasis; if overexpression is + by IHC, then patients must have HER gene amplification documented by fluorescence in situ hybridization (FISH)
Subjects with diagnosis of HER-negative breast cancer that was confirmed by IHC or in situ hybridization (ISH) assessment of tumor samples
Histologically or cytologically confirmed ER+ HER- breast cancer; ER-positivity is to follow local guidelines; if immunohistochemistry (IHC) HER is +, a negative fluorescence in situ hybridization (FISH) test is required
Progesterone receptor negative  defined as less than % staining by IHC\r\n* HER negative defined as  or + using IHC or a ratio of less than . on fluorescence in situ hybridization (FISH) testing; HER of + on IHC should have a ratio of less than . on FISH testing to be considered HER negative
Documentation of HER negative breast cancer at the time of protocol registration; (Note: HER negativity is defined as  or + by immunohistochemistry OR nonamplified or equivocal by fluorescence in situ hybridization [FISH]; status may be defined on the basis of historic results on the breast primary or a metastatic site, whichever is most recent; repeat biopsies are not required for participation in this protocol)
Patients with ALL or B-LL who have M morphology must have local confirmatory testing showing >= % blasts by flow cytometry, fluorescence in situ hybridization (FISH) testing or other molecular method
Tumors must be HER negative defined as HER  or + by immunohistochemistry (IHC) assays and/or lack of gene amplification by fluorescence in situ hybridization (FISH) defined as a ratio <  on invasive tumor by local review
HER-negative breast cancer defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of , + or +; if IHC is +, a negative in situ hybridization (fluorescence in situ hybridization [FISH], chromogenic in situ hybridization [CISH], or silver in situ hybridization [SISH]) test is required by local laboratory testing
Cytogenetics, fluorescence in situ hybridization (FISH) or mutational analysis confirming adverse risk features must have been done within  days prior to enrollment
Human epidermal growth factor receptor  (HER)/neu-negative breast cancer by standard criteria (immunohistochemistry [IHC] < + or fluorescence in situ hybridization [FISH] negative if IHC +) at primary diagnosis
Patients with histologically confirmed, metastatic HER+ (by immunohistochemistry [IHC] + or fluorescence in situ hybridization [FISH] ratio >= .) breast cancer
Patients with HER+ (immunohistochemistry [IHC] + or fluorescence in situ hybridization [FISH]+ R/G > . or silver-enhanced in situ hybridization [SISH]+ HER/chromosome  centromere [CEP] > .) breast cancer with documented central nervous system (CNS) recurrence or progression (potential participants with newly diagnosed brain metastasis who have not received prior treatment for their lesions in the brain are eligible)
Patients have positive HER expression by immunohistochemistry (IHC) (+) or fluorescence in situ hybridization (FISH) testing (> . ratio)
HER positive breast cancer (immunohistochemistry [IHC] + or fluorescent in situ hybridization [FISH] ratio of >= .)
Has sufficient tumor tissue (slides or blocks) available for central confirmatory testing of immunohistochemistry and/or cytogenetics/fluorescence in situ hybridization (FISH) and/or deoxyribonucleic acid mutation analysis (required for study entry but enrollment based on local results) For Dose Escalation Only:
Documented HER overexpression or gene-amplified tumor (immunohistochemistry [IHC] + or IHC + with confirmatory fluorescence in situ hybridization [FISH]+).
Histologically-confirmed metastatic adenocarcinoma of the breast with either invasive primary tumor or metastatic tissue confirmation of HER+ status as defined by immunohistochemistry (IHC) with score of +, or, if + with confirmatory fluorescence in situ hybridization (FISH) ratio of >= .
Patients must have stage IV gastric or GEJ adenocarcinoma with HER overexpression and/or amplification as determined by next generation sequencing assay, (immunohistochemistry [IHC] +) or fluorescent in situ hybridization (FISH+ is defined as HER:chromosome  centromere probe [CEP] ratio >= .); MSKCC confirmation of HER status is not mandatory prior to enrollment and treatment on study; for patients with outside HER testing, if sufficient tissue is available HER testing will be repeated at MSKCC for purpose of analysis and will not impact the patient's eligibility
Documented HER+ breast cancer defined as: + by immunohistochemistry (IHC) or with amplification by in situ hybridization with ratio >= .; results from the local lab are acceptable; eligibility will not be affected by hormone receptor status
Human epidermal growth factor receptor  (HER)-negative tumor by local laboratory testing (immunohistochemistry [IHC] , + regardless of fluorescence in situ hybridization [FISH] ratio; IHC + with FISH ratio lower than . or HER gene copy less than .; FISH ratio of , indicating gene deletion, when positive and negative in situ hybridization [ISH] controls are present)
International Prognostic Index score ?  or DLBCL with double-positive for BCL and c-MYC by IHC (immunohistochemistry) or FISH (fluorescent in situ hybridization) based on local pathology lab assessment.
HER-positive disease by local laboratory testing (immunohistochemistry  positive [IHC +] staining or in situ hybridization positive)
HER-overexpressing patients by local laboratory testing (IHC + staining or in situ hybridization positive).
Patients must have histological documented or cytological confirmed mantle cell lymphoma; cyclin D must be present as evidenced by either fluorescence in situ hybridization (FISH) or immunohistochemical staining
Negative human epidermal growth factor receptor  (HER-)/neu- disease defined as patients with fluorescence in situ hybridization (FISH) ratio < . or < . HER gene copies per nucleus, and IHC staining scores of , +, or +
Histologically confirmed untreated mantle cell lymphoma, with documented cyclin D (BCL) by immunohistochemical stains and/or t(;) by cytogenetics or fluorescent in situ hybridization (FISH)
Documentation of amplified PDGFR by fluorescent in-situ hybridization (FISH), colorimetric in-situ hybridization (CISH), or quantitative polymerase chain reaction (PCR) from tumor tissue (>=  copy number), or over expression by immunohistochemistry (IHC)
HER+ patients by local laboratory testing (IHC + staining or in situ hybridization positive).
Participants' primary and/or metastatic tumor is human epidermal growth factor receptor  (HER)-negative by fluorescence in-situ hybridization (FISH) or chromogenic in-situ hybridization (CISH) or , + overexpression by immunohistochemistry (IHC)
Molecular testing result from Clinical Laboratory Improvement Act (CLIA)-certified laboratory confirming that the tumor tissue has at least one of the following:\r\n* HER overexpression (+ immunohistochemistry [IHC]); Note: HER + IHC is eligible if the tumor is amplified by fluorescence in situ hybridization (FISH)\r\n* HER amplification by in situ hybridization assay (FISH or chromogenic in situ hybridization [CISH] signal ratio >= . or gene copy number > )\r\n* HER amplification by CLIA-certified next generation sequencing (NGS) sequencing assay
Histologically confirmed mantle cell lymphoma with documented expression of cyclin D (BCL) by immunohistochemical stains and/or t (; ) by cytogenetics or fluorescence in situ hybridization (FISH)
Histologically or cytologically confirmed invasive breast cancer that is HER-positive (+ by immunohistochemistry [IHC] and/or > . by fluorescence in situ hybridization [FISH]) if concurrent HER-directed therapy is planned
Confirmed HER-positive disease by local pathology, defined as immunohistochemistry (IHC) + or amplification by fluorescent in situ hybridization (FISH) (HER/chromosome  centromere [CEP] ratio >=  or an average of >=  HER gene copies per nucleus) AND confirmed by Central Pathology Review (Mayo Clinic Rochester) prior to patient being registered to begin protocol therapy\r\n* NOTE: ductal carcinoma in situ (DCIS) components should not be counted in the determination of HER status
Subject has human epidermal growth factor receptor  negative (HER-) breast cancer (based on most recently analyzed biopsy) defined as a negative in situ hybridization test or an Immunohistochemistry (IHC) status of , + or +. If IHC is +, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
Histologically documented HER (+) breast cancer as defined as immunohistochemistry (IHC) + or fluorescence in situ hybridization (FISH) amplification of >= . of primary or metastatic site; results from the local lab are acceptable
Tumors must be HER negative as defined according to ASCO/CAP , as HER -+ by immunohistochemistry (IHC) or non-amplified fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH); if HER IHC is +, FISH/CISH must be performed and must not be positive (must be a ratio of < ), but otherwise FISH/CISH is not required if IHC is  or + by institutional standards
Documented results of cytogenetics/ fluorescence in situ hybridization (FISH) obtained at any time before transplant, and International Staging System (ISS) staging at the time of diagnosis available.
Patients must have histologically or cytologically confirmed mantle cell lymphoma as defined by the World Health Organization; all patients must have either t(;) by karyotype or fluorescent in-situ hybridization (FISH) or positive immunohistochemistry for cyclin D
Patients must have histologically-confirmed HER-positive breast cancer that is locally advanced or metastatic; HER-positive disease must be documented by one of the following results using Food and Drug Administration (FDA)-approved testing methods: \r\n* Fluorescence in situ hybridization (FISH)-positive (with an amplification ratio >= . indicating positive status) and/or \r\n* Immunohistochemistry (IHC)  + by local laboratory assessment
A cytogenetics or fluorescence in situ hybridization (FISH) analysis of the leukemic cells within  months of randomization is required to document the presence or absence of del(p). Note: if a sample from within  months is not available, it should be evaluated as part of the screening laboratory evaluation to inform stratification
Human growth factor receptor  (HER) positive tumors as defined by Food and Drug Administration (FDA) guidelines (+ immunohistochemical staining, defined as uniform, intense membrane staining of more than % of invasive tumor cells, and for cases with + staining showing gene amplification by fluorescence in situ hybridization [FISH], expressed as a ratio of more than  when comparing HER- gene and chromosome  fluorescent signals)
HER+ metastatic breast cancer, documented as HER+ by FISH and/or + staining by immunohistochemistry.
Patient has HER-negative breast cancer defined as a negative in situ hybridization test or an IHC status of , + or +. If IHC is +, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
HER overexpression and/or amplification as determined by immunohistochemistry (+) or fluorescence in situ hybridization (FISH) (>= .)
Documented HER overexpression (immunohistochemistry [IHC] + or gene-amplified tumor with fluorescence in situ hybridization [FISH] ratio of >= .)
Patients have HER-positive breast carcinoma (IHC staining more than + or HER gene amplification by fluorescent in situ hybridization [FISH])
HER overexpression by immunohistochemistry (IHC) of + or + in the primary tumor or metastasis; or documented gene amplification by fluorescent in situ hybridization (FISH) analysis; IHC =< + must have HER gene amplification documented by FISH
Patients with histologically confirmed stage I-III, HER-positive invasive breast cancer for which adjuvant/neoadjuvant chemotherapy is indicated based on physician judgment following National Comprehensive Cancer Network (NCCN) practice guidelines\r\n* HER overexpression or amplification will be based on local test results and is defined as either:\r\n** Immunohistochemistry (IHC) staining of + (uniform, intense membrane staining) in >= % of invasive tumor cells or\r\n** Fluorescent in situ hybridization (FISH) result of more than six HER gene copies per nucleus or\r\n** FISH ratio (HER gene signals to chromosome  signals) of >= .
PRE-REGISTRATION INCLUSION CRITERIA: Histologically confirmed HER-negative primary invasive ductal or invasive lobular breast carcinoma; for patients enrolling for neoadjuvant treatment, diagnosis must be clinical stage II or III; for patients enrolling for adjuvant treatment, diagnosis must be pathologic stage IIA to IIIC\r\n* Standard HER testing will be performed in the surgical specimen at Washington University according to the standard of care in the department of pathology; a HER-negative primary breast cancer sample from a patient eligible for randomization should have a HER immunohistochemistry (IHC) score of  or +; those patients with IHC score of + should be HER fluorescent in situ hybridization (FISH)-negative in standard testing\r\n* Patient will have undergone staging studies including a computed tomography (CT) of the chest/abdomen/pelvis and bone scan and/or positron emission tomography (PET) scan either prior to the initiation of treatment or prior to entry into the trial\r\n* In addition, patients with non-metastatic, HER-negative, recurrent tumors who need chemotherapy are eligible
An adverse risk karyotype defined by:\r\n* Complex karyotype by cytogenetics, or\r\n* Deletion of all or part of chromosome , , , or  defined by fluorescence in situ hybridization (FISH) or cytogenetics, or\r\n* Somatic TP mutation
HER negative, defined as -+ by immunohistochemistry or FISH-negative (ratio < .); central confirmation is not required
Participants must have a diagnosis of chronic myelogenous leukemia as confirmed by fluorescent in situ hybridization (FISH) for BCR/ABL translocation and/or standard cytogenetics analysis
Her- normal as determined by fluorescence in situ hybridization (FISH) or  or + by immunohistochemistry (IHC) staining.
Confirmed pathologic diagnosis of breast cancer which is metastatic and for which capecitabine is a reasonable treatment option\r\n*ARMS C & D: Histologically confirmed human epidermal growth factor receptor  (HER) positive (+) breast cancer: immunohistochemistry (IHC) + or fluorescence in situ hybridization (FISH) amplified; by clinical assay on either primary or metastatic tumor
Patients with high risk cytogenetics at diagnosis must have achieved at least very good partial response following autologous stem cell transplantation (cohort ):\r\n* Patients must have complex karyotype, q, delp, t; and/or t; by fluorescence in situ hybridization (FISH) and/or del by karyotyping
Patients must have esophageal, gastric or gastroesophageal adenocarcinoma with HER overexpression and/or amplification as determined by next generation sequencing assay, immunohistochemistry (IHC +) or fluorescent in situ hybridization (FISH+ is defined as HER:CEP ratio >= .); MSKCC or enrolling institution confirmation of HER status is not mandatory prior to enrollment and treatment on study; for patients with outside HER testing, if sufficient tissue is available HER testing will be repeated at MSKCC or the enrolling institution for purpose of analysis and will not impact the patient's eligibility
For patients with evidence of minimal residual disease prior to vaccination, assessment of minimal residual disease status by cytogenetics or fluorescence in situ hybridization (FISH) will be followed post vaccination
HER-positive breast carcinoma (IHC staining more than + or HER gene amplification by fluorescent in situ hybridization [FISH])
Patients who have already received an allogeneic hematopoietic cell transplant and have either a documented relapse of leukemia or MDS or have recurrent persistent minimal residual disease as documented by at least  sequential testings, separated by  week, demonstrating molecular evidence of leukemia or MDS by fluorescence in situ hybridization (FISH), cytogenetics or fluorescent immunocytometry
Patients must have HER-positive (fluorescence in situ hybridization [FISH]+ or immunohistochemistry [ICH] +) metastatic or unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma to be eligible for trastuzumab; for the purposes of this protocol, FISH+ is defined as HER:centromeric probe for chromosome  (CEP) ratio >= .; biopsy samples with cohesive IHC+ or FISH+ clones are considered HER positive irrespective of size, i.e. < %; FISH+ defined as >  HER:CEP; Note: samples will be processed locally in the laboratory of investigational sites; the results of local laboratory HER analysis will be required and sufficient to start the study treatment; the Memorial Sloan-Kettering (MSK) laboratory will be used for subsequent confirmation of HER status; MSK pathology review will not be required to begin therapy on the protocol; samples provided to the MSK laboratory must either be HER IHC slides, or if FISH confirmation is necessary, a paraffin block(s) of adequate size to allow if possible for at least  slides with cuts that are -microns thick or if a paraffin block is not available, then if possible at least  slides with cuts that are -microns thick will be acceptable; archived or fresh tumor samples may be used
Documentation of complete cytogenetic response (CCR) by conventional cytogenetics or fluorescent in situ hybridization (FISH) analysis on a frontline TKI with stable dosing
Myc positive lymphoma is defined by:\r\n* Positive for Myc gene rearrangement by fluorescence in-situ hybridization (FISH) involving various breakpoints (e.g. -, - and -) AND concurrent gene rearrangements in bcl- and/or bcl- by FISH OR\r\n* Myc and Bcl- overexpression defined by >= % Myc and > % Bcl- expression by immunohistochemistry (IHC); patients may enroll in the study based on the local laboratory evaluation, but these should be confirmed by the University of North Carolina (UNC) Hematopathology Laboratory retrospectively
Patients meeting the above pathologic criteria will be eligible for therapy irrespective of their HER/neu over expression status; immunohistochemical staining will be not be required for protocol entry but fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC) studies for HER/neu are preferred
Have negative HER expression by immunohistochemistry (IHC) (defined as  or +), or fluorescence in situ hybridization (FISH); if HER is +, negative HER expression must be confirmed by FISH
Tumor must be HER positive + by immunohistochemistry or positive by fluorescence in situ hybridization (FISH) analysis if + by immunohistochemistry
Double hit lymphoma is defined as B-cell lymphoma with genetic abnormalities involving A) and in addition, B) and/or C): A) v-myc myelocytomatosis viral oncogene homolog (avian) (C-MYC) arrangement or amplification by fluorescence in situ hybridization (FISH) study; B) B-cell chronic lymphocytic leukemia (CLL)/lymphoma  (BCL) rearrangement or amplification by FISH study; C) BCL rearrangement or amplification by FISH study
Tumors must be HER-/neu expression negative, as determined by local hospital laboratory (immunohistochemistry [IHC] =< + or fluorescence in situ hybridization [FISH] negative)
Females with histologically or cytologically confirmed HER-positive breast cancer. HER-positive is defined as + staining by immunohistochemistry or HER gene amplification by fluorescent in situ hybridization or silver in situ hybridization with HER/CEP ratio ? .
Presence of p deletion in CLL cells as demonstrated by fluorescence in-situ hybridization (FISH) testing
The invasive cancer must be HER-negative (IHC -+, or with a fluorescence based in situ hybridization [FISH] ratio of < . if IHC is + or if IHC has not been done)
Clinical T-Tc, any N, M invasive ER+ (Allred score of -) and HER negative ( or + by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH] negative for amplification) breast cancer, by American Joint Committee on Cancer (AJCC) th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node; \r\n* Note: if the patient has invasive or ductal carcinoma in situ (DCIS) in the contralateral breast the patient is not eligible for this study
Any Her + breast cancer (immunohistochemistry +; or amplified by fluorescence in situ hybridization [FISH])
Invasive breast cancer must be Her-negative; if breast cancer is Her + by immunohistochemistry (IHC), then fluorescence in situ hybridization (FISH) must be negative for Her gene amplification
Human epidermal growth factor receptor  (HER) normal (immunohistochemistry [ICH] -; fluorescence in situ hybridization [FISH] < .)
Tumor determined to be HER-positive by immunohistochemistry (+) or by fluorescent in situ hybridization (HER/CEP amplification ratio >= .); tumors determined to be ER or PR positive by immunohistochemistry (> % )
Patient has HER negative breast cancer defined as a negative in situ hybridization test or an IHC status of  or + as per local laboratory testing
HER positive as determined by score of  on immunohistochemistry (IHC) staining or gene amplification by fluorescence in situ hybridization (FISH).
Local histologic or cytologic confirmation of HER+ solid tumors by fluorescent in situ hybridization (FISH) amplification or immunohistochemistry (IHC) (+)
Patients are required to have HER+ breast cancer defined as a fluorescent in situ hybridization (FISH)- ratio of >= . or immunohistochemistry (IHC) +
Tumor negative for HER expression ( or + by immunohistochemistry [IHC]) or negative fluorescent in situ hybridization (FISH) testing
HER-positive disease documented as in situ hybridization (ISH)-positive and/or + by immunohistochemistry (IHC) on previously collected tumor tissue
HER/neu-negative breast cancer by standard criteria (immunohistochemistry [IHC] < + or fluorescence in situ hybridization [FISH]-negative if IHC +) at primary diagnosis
Patients who have failed at least one line of a standard treatment, including bendamustine, fludarabine, ibrutinib, or alemtuzumab and require treatment within  years of completion of last treatment regimen or untreated with delp by fluorescence in-situ hybridization (FISH) (high-risk) who do not have an allogeneic stem cell transplant option
Hematologic malignancy in complete remission with minimal residual disease (MRD) detectable by conventional cytogenetics, fluorescence in situ hybridization (FISH), flow cytometry, or molecular testing
Human epidermal growth factor receptor  (HER)-overexpressing breast cancer by local laboratory testing (immunohistochemistry [IHC] + staining or fluorescent in situ hybridization [FISH] positive)
Patients with non-metastatic, node positive, HER negative breast cancer, confirmed by pathology report, who are in remission and defined as having no evidence of disease (NED); HER negative is defined as\r\n* -+ HER expression by immunohistochemistry (IHC) OR\r\n* Fluorescence in situ hybridization (FISH) negative OR\r\n* HER + and FISH negative
Subjects with invasive breast cancer at least stage IIIA >= N (>  positive nodes) or have recurrent metastatic breast cancer rendered no evidence of disease (NED) by any means that are classic HER- + %, + immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) positive or HER- + FISH negative that have completed chemotherapy and/or trastuzumab and have no evidence of disease
HER/neu-expressing tumor (immunohistochemistry [IHC] + and/or amplified fluorescence in situ hybridization [FISH] >., or N (i+))
History of HER/neu positive cancer (IHC + and/or fluorescence in situ hybridization [FISH] positive) as assessed by medical record review at screening
Pathologically or cytologically confirmed metastatic or primary esophagogastric cancer; HER positive status by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) as currently being implemented for patients with esophagogastric cancer; HER overexpression and/or amplification as determined by IHC (+) or FISH (>= .)
Two patients must be HER + by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) positive
The cancer must over express HER as determined by immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH)
Cohort : Her-positive (defined as +) or fluorescence in situ hybridization (FISH) HER:Chromosome  centromere (CEP) ratio >  biopsy-proven breast cancer
Cohort : Her-positive (defined as +) or FISH HER:CEP ratio >  OR HER-negative ( or +, + and FISH negative) biopsy-proven breast cancer
Histologically confirmed HER+ breast cancer: immunohistochemistry (IHC) + or fluorescence in situ hybridization (FISH) amplified; by clinical assay on either primary or metastatic tumor
For patients with evidence of minimal residual disease prior to vaccination, assessment of minimal residual disease status by cytogenetics or fluorescence in situ hybridization (FISH) will be followed post vaccination
Tumor HER/neu expression must be determined (as part of standard clinical care) prior to study enrollment; HER may be tested by any Food and Drug Administration (FDA) approved HER testing method; if determination is intermediate by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) or another alternate HER test must be performed
The patient is receiving preoperative chemotherapy other than adriamyacin, cyclophosphamide, and a taxane (ACT) in standard or dose-dense fashion; herceptin may be added to the neoadjuvant chemotherapy regimen in cases where the tumor is Human Epidermal growth factor Receptor  (Her-)/neu positive by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)