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    Association details:
    Biomarker:HER-2 overexpression
    Cancer:Breast Cancer
    Drug:Herceptin (trastuzumab) (HER2 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    European Medicines Agency
    Excerpt:
    Herceptin should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay...It is also used in combination with other anticancer medicines: with paclitaxel or docetaxel, or with an aromatase inhibitor.
    Secondary therapy:
    Aromatase inhibitor; paclitaxel; docetaxel
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    Therapeutic Goods Administration
    Excerpt:
    HERCEPTIN SC is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2...in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease
    Secondary therapy:
    Chemotherapy
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    Herceptin is a HER2/neu receptor antagonist indicated for: The treatment of HER2-overexpressing breast cancer.
    Secondary therapy:
    carboplatin + docetaxel; paclitaxel + doxorubicin hydrochloride + cyclophosphamide; docetaxel + doxorubicin hydrochloride + cyclophosphamide; paclitaxel
    Test:
    Bond Oracle HER2 IHC System
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    Therapeutic Goods Administration
    Excerpt:
    HERCEPTIN SC is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2...as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer

    Excerpt:
    ...- Documentation of HER2 overexpression or gene amplification, in the invasive component of either the primary tumor or metastatic disease site as defined as: 3+ by Immunohistochemistry (IHC) and/or...
    Trial ID:
    NCT02213042
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer

    Excerpt:
    ...- ErbB2(HER2)overexpressing breast cancer....
    Trial ID:
    NCT00263588
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Lapatinib and Trastuzumab With or Without Endocrine Therapy

    Excerpt:
    ...- HER2 overexpressing tumors defined as HercepTest score of 3+, or > 10% cells moderately or strongly HER2 positive by other methods, or Allred semi-quantitative score of >5, or gene amplified....
    Trial ID:
    TBCRC 006
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Phase II Trial to Validate Markers for a Response Evaluation of a Combined Therapy in Patients With HER2+ Breast Cancer

    Excerpt:
    ...HER2 over-expressing tumor confirmed by: 3+ by Immuno-histochemistry (IHC) and/or HER2/neu gene amplification by fluorescence, chromogenic or silver in-situ hybridization [Fluorescent In-Situ Hybridization (FISH), Chromogenic In-Situ Hybridization (CISH) or Silver In-Situ Hybridization (SISH); > 6 HER2 gene copies per nucleus or a FISH, CISH or SISH test ratio (HER2 gene copies to chromosome 17 signals) of ≥ 2.0] 5....
    Trial ID:
    NCT01891357
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Continued HER2 Suppression With Lapatinib Plus Trastuzumab Versus Trastuzumab Alone

    Excerpt:
    ...- Documentation of HER2 overexpression or gene amplification in the invasive component of either the primary tumor or metastatic disease site defined as:...
    Trial ID:
    NCT00968968
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Chemotherapy and Peripheral Stem Cell Transplantation Followed by Trastuzumab in Treating Women With Metastatic Breast Cancer

    Excerpt:
    ...Histologically confirmed stage IV breast cancer that overexpresses HER2/neu Evidence of at least a partial response (at least 50% reduction) to salvage chemotherapy as initial chemotherapy for metastatic disease Measurable disease...
    Trial ID:
    NCT00006123
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Novel Capecitabine Dosing Schedule in Combination With Lapatinib, Based on the Norton-Simon Mathematical Method in Patients With HER2 Overexpressed/Amplified, Trastuzumab (Herceptin) -Refractory, Metastatic Breast Cancer

    Excerpt:
    ...- HER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or FISH (≥2.0)....
    Trial ID:
    NCT00721630
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Assessment of Cardiotoxicity by Cardiac Magnetic Resonance (CMR) in Breast Cancer Patients Receiving Trastuzumab

    Excerpt:
    ...- Histologically confirmed HER2 overexpression using IHC and/or FISH and/or DISH...
    Trial ID:
    NCT01022086
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Safety of Herceptin/Trastuzumab in Metastatic Breast Cancer

    Excerpt:
    ...- Confirmed diagnosis of metastatic breast cancer (BC) with HER2-neu overexpression...
    Trial ID:
    NCT02424682
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Clinical Trial of the Combination of Trastuzumab (Herceptin) and Tanespimycin in Patients With Solid Tumors and Her2 Positive Metastatic Breast Cancer That Have Previously Failed Herceptin

    Excerpt:
    ...For the Phase 2 portion of the trial, patients must have metastatic breast cancer with HER2 amplification by FISH or 3+ HER2 overexpression by immunohistochemistry ("IHC") Patients may have had either progressive disease within 3 months following last dose of adjuvant treatment with trastuzumab OR progressive disease following initial therapy for metastatic disease with trastuzumab (trastuzumab may have been administered with cytotoxic chemotherapy, hormonal therapy or as single agent.) Patients who have received trastuzumab single agent therapy (without documented progressive disease) followed by trastuzumab combination therapy remain eligible for this study at the time of disease progression....
    Trial ID:
    NCT00773344
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Cancer Stem Cell Biomarkers as a Predictor of Response to Trastuzumab in Samples From Patients With Breast Cancer Previously Treated in the NSABP-B-31 Trial

    Excerpt:
    ...- Tissue samples from patients with node-positive breast cancer whose tumors overexpress HER2...
    Trial ID:
    NCT01424865
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer

    Excerpt:
    ...- HER2 overexpression;...
    Trial ID:
    NCT02015676
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Cardiotoxicity of Adjuvant Trastuzumab

    Excerpt:
    ...- Histologically confirmed, completely excised invasive breast cancer with Her-2 overexpression...
    Trial ID:
    CATS
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Combination Chemotherapy With or Without Trastuzumab in Treating Women With Metastatic Breast Cancer

    Excerpt:
    ...for this protocol, HER2/neu non-overexpressed status will be defined as 0 and 1+ scores using the DAKO HercepTest; HER2 overexpressed status will be defined as 2+ score (if confirmed amplified by FISH) or 3+ score using the DAKO HercepTest...
    Trial ID:
    NCT00004888
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Trastuzumab or Observation After Combination Chemotherapy and Trastuzumab in Treating Patients Undergoing Surgery for Stage II or Stage III Breast Cancer

    Excerpt:
    ...- HER2/neu overexpression (3+) by immunohistochemistry (IHC)...
    Trial ID:
    NCT00533936
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Phase II, Randomized, Open-label Study of Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy in HER2-positive and p95HER2-positive Metastatic Breast Cancer

    Excerpt:
    ...- Documentation of HER2 overexpression or gene amplification, in the invasive component of either a metastatic disease site or primary tumor, defined as: 3+ by IHC and/or HER2/neu gene amplification by fluorescence, chromogenic or silver in situ hybridization [FISH, CISH or SISH; >6 HER2/neu gene copies per nucleus or a FISH, CISH or SISH test ratio (HER2 gene copies to chromosome 17 signals) of ≥2.0]...
    Trial ID:
    NCT01137994
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer

    Excerpt:
    ...- Primary invasive breast cancers that overexpress the HER2/neu oncogene...
    Trial ID:
    NCT00136539
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer

    Excerpt:
    ......
    Trial ID:
    NCT00016276
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Phase II Neoadjuvant Trial of Trastuzumab in Combination With Dose-Dense ABI-007 (Abraxane™)

    Excerpt:
    ...- 3+ HER2 overexpression by IHC or 2+ HER2 overexpression and FISH positivity....
    Trial ID:
    NCT00503750
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Lapatinib In Combination With Chemotherapy In Subjects With Relapsed Breast Cancer

    Excerpt:
    ...- Documented amplification of the ErbB2 gene by fluorescence in situ hybridization (FISH) or documented overexpression of the ErbB2 protein by 3+ IHC in primary or metastatic tumor tissue....
    Trial ID:
    NCT00479856
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Efficacy Study of Single Agent Trastuzumab or Lapatinib to Treat HER2-Overexpressing Breast Cancer

    Excerpt:
    ...- HER2-Overexpression proven by Fluorescence in Situ Hybridization (FISH)....
    Trial ID:
    HERLAP
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A Phase II, Randomized, Open-label Study of Lapatinib Plus Chemotherapy versus Trastuzumab Plus Chemotherapy as Firstline Treatment for Women with HER2-positive and p95HER2-positive Metastatic Breast Cancer

    Excerpt:
    ...Documentation of HER2 overexpression or gene amplification, in the invasivecomponent of either a metastatic disease site or primary tumor, defined as:• 3+ by IHCand/or• HER2/neu gene amplification by fluorescence, chromogenic or silver insitu hybridization [FISH, CISH or SISH; >6 HER2/neu gene copies pernucleus or a FISH, CISH or SISH test5. ...
    Trial ID:
    2010-019390-15
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    HERA (HERceptin Adjuvant) Trial

    Excerpt:
    ...Eastern Cooperative Oncology Group (ECOG) performance status = 1; Non-metastatic operable primary invasive adenocarcinoma of the breast that is: histologically confirmed, adequately excised, axillary node positive or negative, and tumour size =T1c according to TNM; Known hormone receptor status (ER/PgR or ER alone); Patient must have received at least four cycles of an approved (neo-) adjuvant chemotherapy regimen; Baseline LVEF = 55% measured by echocardiography or MUGA scan after completion of all (neo-) adjuvant chemotherapy and radiotherapy); Completion of radiotherapy for any patients undergoing radiotherapy; Overexpression of HER2 in the invasive component of the primary tumour, according to one of the following definitions: 3+ overexpression by IHC or 2+ overexpression by IHC AND fluorescence in situ hybridisation (FISH) test demonstrating c-erbB2 gene amplification, or c-erbB2 gene amplification by FISH; Completion of all necessary baseline lab and radiologic investigations; Signed written informed consent...
    Trial ID:
    ACTRN12607000011482
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A study to investigate the use of Lapatinib and Capecitabine together versus Trastuzumab and Capecitabine together to treat metastatic breast cancer.

    Excerpt:
    ...ErbB2 overexpression in the invasive component of the primary or metastatic lesion as locally defined by: • 3+ staining by immunohistochemistry (IHC); • or 2+ staining by IHC in conjunction with ErbB2 gene amplification by FISH,CISH or SISH; • ErbB2 gene amplification by FISH, CISH or SISH HER2/neu gene amplification by fluorescence, chromogenic or silver in situ hybridization [FISH, CISH or SISH; >6 HER2/neu gene copies per nucleus or a FISH, CISH or SISH test ratio (HER2 gene copies to chromosome 17 signals) of ≥2.0] • subjects with a negative or equivocal overall result are not eligible for participation in the trial. ...
    Trial ID:
    2008-000673-38
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Phase II study of Herceptin® alone or in combination with a taxane, as a first-line treatment for patients with metastatic breast cancer, who have relapsed after receiving Herceptin® in the adjuvant setting for HER2 positive early breast cancer

    Excerpt:
    ...HER2 positive primary disease (3+ HER2 overexpression measured by immunohistochemistry, or HER2 amplification measured by FISH), confirmed by the central laboratory. ...
    Trial ID:
    2004-000752-17
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    The diagnosis and treatment of patients with HER2-positive breast cancer

    Excerpt:
    ...1) We required patients to have an Eastern Cooperative Oncology Group performance status of 0~2; 2) HER2（+++）or FISH:HER2 over-expression; 3) Survival time > 3 months; 4) Important viscera function is basically normal, Blood routine and liver and kidney function basically normal, no treatment taboo card....
    Trial ID:
    ChiCTR1800017467
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Study on the influence of mCRP on the curative effect of herceptin on breast cancer

    Excerpt:
    ...Breast cancer with her-2 over expression and treated with herceptin....
    Trial ID:
    ChiCTR-TNRC-09000620
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A randomized, multicentre, open-label Phase III study of lapatinib in combination with trastuzumab versus lapatinib monotherapy in subjects with metastatic breast cancer whose disease has progressed on trastuzumab-containing regimens

    Excerpt:
    ...Documented amplification of the ErbB2 gene by fluorescence in situ hybridization (FISH) or documented overexpression of the ErbB2 protein by IHC in primary or metastatic tumor tissue. ...
    Trial ID:
    2005-003926-24
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    PEGYLATED LIPOSOMAL DOXORUBICIN (CAELYX), CISPLATINUMAND FLUOROURACIL AS CONTINUOUS INFUSION (CCF) PLUSTRASTUZUMAB (HERCEPTIN) IN THE PREOPERATIVE TREATMENT OFLOCALLY ADVANCED BREAST CANCER

    Excerpt:
    ...ﾕ Patients with histologically proven locally advanced primary breast cancer (cT2-T3-T4 ad,N0-3c, M0) orPatients with histologically proven local recurrence after breast conserving surgery (rT1-T4, N0-3c, M0) orPatients with histologically proven local recurrence after mastectomy (M1 on the chestwall) orPatients with histological proven regional recurrence (axillary, suvraclavicular and internalmammary chain lymph nodes)ﾕ Patients with HER2 overexpression (+++)or with Her2/neu gene amplificationﾕ Patients must be suitable for local treatment (radiotherapy and/or surgery) in amultidisciplinary programﾕ Bilateral breast cancers are eligibleﾕ Women aged 18ﾖ75 yearsﾕ ER PgR and c-erbB-2 expression defined according to EIO guidelinesﾕ Performance status 0-2 (ECOG scale)ﾕ Measurable and/or evaluable lesionsﾕ No evidence of distant metastatic diseaseﾕ No clinically significant concomitant illness such as diabetes, cardiovascular, renal, orneurological impairmentsﾕ LVEF >= 55% at basal echocardiographyﾕ Absence of psychiatric illness undermining a correct understanding of the treatmentprogramﾕ WBC > 3,000/mm3; PLTS > 100,000/mm3ﾕ AST, ALT, gamma-GT < 2.5 x upper normal limit and bilirubin < 1.5 mg/dlﾕ Serum creatinine in the normal rangeﾕ Institutional Signed Written Informed Consent obtainedﾕ Pregnancy test (in fertile women). ...
    Trial ID:
    2006-006010-15
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    National Surgical Adjuvant Study of Breast Cancer(N-SAS BC) 07 [RESPECT]

    Excerpt:
    ...Primary region is HER 2 positive: either 3+ overexpression by IHC or positive by FISH 5....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Efficacy and toxicity of Trastuzumab at the maintaining dose of 1 mg/kg/week versus the standard dose of 2 mg/kg/week in combination with chemotherapy in metastatic breast cancer patients. A phase III multicenter study. Efficacia e tossicita` di Trastuzumab alla dose di mantenimento di 1 mg/kg/settimana verso la dose convenzionale di 2 mg/kq/settimana in associazione alla chemioterapia nel tumore della mammella metastatico. Studio multicentrico di fase III.

    Excerpt:
    ...Overexpression of HER2 (Appendix IV) 7. ...
    Trial ID:
    2007-006060-29
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A multicenter randomized phase III study to compare capecitabine alone or in combination with trastuzumab in patients with HER2 positive metastatic breast cancer and progression after previous treatment with trastuzumab (Treatment Beyond Progression, TBP).

    Excerpt:
    ...HER2-overexpression of the primary or metastatic tumor tissue detected by immunohistochemistry (DAKO) 3+ or genamplification detected by FISH. ...
    Trial ID:
    2005-002084-85
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    trastuzumab, docetaxel and oxaliplatino association in metastatic breast cancer with her2 receptor overexepression Phase II clinical trial

    Excerpt:
    ...Histological diagnosis of breast cancer - HER2 overexpression immune histological determination with positivity score 3 or 2 FISH confirmed - Instrumental evidence for metastatic diffusion measurable disease; RECIST parameters - Patients aged 18 to 70 years - PS ECOG between 0 and 2 - Life expectancy 6 months - Adequate bone marrow functionality leucocytes 8805; 3.0 109/L, neutrophils 1.5 109/L, platelets 8805; 100 109/L, haemoglobin 9g/dl - Adequate hepatic functionality total bilirubin 8804; 1.25 x UNV, transaminase 8804;3 x UNV, alkaline phosphatase 8804;2.5xUNV - Adequate renal functionality creatinine 8804;1.3 x UNV - Cardiac ejection fraction equal at least to 50 - Any concluded adjuvant or metastatic disease hormonal treatment has admitted - Premenopausal women using effective methods off birth controll and negative pregnancy test on 2 weeks before chemotherapy s beginning - Written informed consent...
    Trial ID:
    2006-000413-37
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    SPONTANEOUS STUDY WITH ADJUVANT TRASTUZUMAB HERCEPTIN IN WOMEN WITH HER-2 POSITIVE PRIMARY BREAST CANCER WHO HAVE COMPLETED ADJUVANT CHEMOTHERAPY

    Excerpt:
    ...Female gender Age 61619; 61472;18 years Eastern Cooperative Oncology Group ECOG performance status 1 Signed written informed consentE Overexpression of HER2 in the invasive component of the primary tumor, according to one of the following definitionsD - 3 overexpression by IHC - 2 overexpression by IHC AND fluorescence in situ hybridisation FISH test PathVysion or INFORM 61650; 61472;HER-2/neu demonstrating C-erbB2 gene amplification ratio of c-erbB2 gene signals to centromere 17 signals 2 - c-erbB2 gene amplification by FISH ratio of c-erbB2 gene signals to centromere 17 signals 2 Completion of adjuvant chemotherapy and radiotherapy for all patients undergoing radiotherapy Adequate bone marrow, liver and renal functions Baseline LVEF 55 measured by echocardiography or MUGA scan...
    Trial ID:
    2005-005274-71
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Pharmacogenetic study of FcγRIIIa and HER2 genes in relation to treatment of breast cancer

    Excerpt:
    ...The primary endpoint of this study is the frequency of specific genetic variations between individuals: in the HER2 gene with respect to HER2 receptor expression and the FcγRIIIa and related genes with respect to response to trastuzumab in the treatment of HER2-overexpressing breast cancer....
    Trial ID:
    2006-002532-24
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Early Predictor of Herceptin Cardio Toxicity in Breast Cancer Patients

    Excerpt:
    ...Breast cancer cases with histopathology prove of invasive carcinoma with HER 2 over expression detected by immunochemical stain and/ or FISH....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    EVALUATION OF ACQUIRED OVEREXPRESSION OF HER2/neu ON CIRCULATING TUMOR CELLSIN PATIENTS WITH ADVANCED BREAST CANCER DURING CHEMOTHERAPY, AND ASSESSMENT OF ACTIVITY OF TRASTUZUMAB-BASED THERAPY:A PHASE II TRIAL

    Excerpt:
    ...Patients with Metastatic breast cancer (MBC) are considerate eligible.- For the evaluation of concordance between the primary tumour andCTCs, we will be considered eligible patients with MBC, untreated formetastatic disease, with HER-2/neu overexpressed or not on primarytumour, before to start any treatment.- For the evaluation of acquisition of HER-2/neu overexpression, willbe considered eligible patients with MBC and HER-2/neu negative onprimary tumour, pre-treated with at least one line of chemotherapy.Patients evaluated in the first part of the study, with HER-2/neunegative on primary tumour evaluation and on CTCs, will be valuablefor the second part of the study.- For the evaluation of efficacy of trastuzumab-based therapy, will beconsidered eligible those patients with HER-2/neu absent on primarytumour, that acquired HER-2/neu overexpression on CTCs...
    Trial ID:
    2008-000341-64
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    RANDOMIZED CLINICAL TRIAL TO COMPARE THE BENEFIT OF ADDING HERCEPTIN TO CAPECITABINE PLUS VINORELBINE AS SECOND LINE TREATMENT FOR PATIENTS WITH LOCALLY ADVANCED NON OPERABLE OR METASTATIC BREAST CANCER WITH OVEREXPRESSION OF HER-2, WHO HAVE PROGRESSED TO A PREVIOUS LINE OF TREATMENT FOR METASTATIC DISEASE WITH TRASTUZUMAB IN COMBINATION WITH TAXANES

    Excerpt:
    ...Patients must sign an informed consent before of specific procedures of clinical trial.Patients with histologically confirmed breast cancer and overexpression of HER2.Age > 18 years.Patients with locally advanced non operable or mestatatic breast cancer previously treated with a regimen of chemotherapy that included trastuzumab and taxanes.Clinical measurable or not measurable disease defined by the RECIST criteria. ...
    Trial ID:
    2005-000405-56
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Prospective phase II trial using Capecitabine and Trastuzumab for therapy of female patients with cerebral metastasizing, HER2-overexpressing breast cancer

    Excerpt:
    ...- Histological proven metastasizing breast cancer in women- HER2-new-overexpression (IHC3+ or IHC2+/FISH+) - Documented CNS metastases and/or Meningeosis carcinomatosa which are (neurosurgical) inoperable - if no irradiation has been performed before study treatment (chemoimmunotherapy) it will be conducted in- If a previous irridiation took place and it is not clinically indicated to be continued, this chemoimmunotherapy will be conducted analog and squentiell to study treatment after previous irradiation- Besides Capecitabine all prior adjuvant /neoadjuvant chemotherapies possible- Patients have to be treated with taxanes and Trastuzumab (not necessarily in combination) before, excluding cases of primary inoperable CNS metastases- Prior hormone therapy is allowed- Age between 18 and 75 years- Performance status (Karnofsky) >= 70%- Life expectancy >= 16 weeks- Signed informed consent after complete information by the investigator before study specific treatment....
    Trial ID:
    2007-003634-42
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Distribution of Herceptin in patients with metastasised breast cancer with a Herceptin labelled radioactive tracer, visualised on PET/CT and PET images. Distributie van Herceptin in patienten met gemetastaseerd borstkanker met een aan Herceptin gebonden radioactieve stof zichtbaar op PET/CT en PET scan beelden.

    Excerpt:
    ...Histological confirmed breast cancer (5 with and 5 without HER2/neu overexpression or amplification), with a primary tumour and at least 1 distant metastatic lesion.Recent diagnostic 18F-FDG PET/CT (less than 1 month old) made at the NKI-AvL....
    Trial ID:
    2014-002800-25
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Combination Chemotherapy With Trastuzumab in Treating Women With Metastatic Breast Cancer

    Excerpt:
    ...- Histologically confirmed metastatic breast cancer c-erbB2 positive (3+ overexpression by the HercepTest™ method) in the primary tumor or metastatic site...
    Trial ID:
    NCT00036868
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Pre Operative Trastuzumab in Operable Breast Cancer

    Excerpt:
    ...Documentation of erbB-2 gene amplification by FISH (as defined by a ratio >2.2) or chromogenic in situ hybridization (CISH, as defined by the manufacturer's kit instruction) or documentation of erbB-2-overexpression by IHC (defined as IHC3+, or IHC2+ with FISH or CISH confirmation) based on local laboratory....
    Trial ID:
    NCT01785420
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Trastuzumab and RAD001 in Patients With Human Epidermal Growth Receptor 2 (HER-2) Overexpressing Breast Cancer

    Excerpt:
    ...History of biopsy-proven HER-2-overexpressing breast cancer and radiographic evidence of metastatic disease....
    Trial ID:
    NCT00317720
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Extension Study of Lapatinib Plus Herceptin With or Without Endocrine Therapy

    Excerpt:
    ...Patients must have histologically confirmed invasive mammary carcinoma that is HER2 overexpressing, defined as 3+ by immunohistochemistry, or a FISH/CEP ratio greater than 2....
    Trial ID:
    HELEX
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab

    Excerpt:
    ...- HER2 overexpression by immunohistocytochemistry (IHC) of 2+ or 3+, in the primary tumor or metastasis; if overexpression is 2+ by IHC, then patients must have HER2 gene amplification documented by fluorescence in situ hybridization (FISH)...
    Trial ID:
    NCT00194714
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer

    Excerpt:
    ...- HER-2 overexpression (FISH + or IHC 3+);...
    Trial ID:
    NCT00337649
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Herceptin Followed by Chemotherapy in Treating Women With Metastatic Breast Cancer That Overexpresses HER2

    Excerpt:
    ...- Histologically confirmed HER2-overexpressing metastatic breast carcinoma...
    Trial ID:
    SAKK 22/99
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Randomized Study of TH Versus THL in First Line Treatment of HER2-positive Metastatic Breast Cancer

    Excerpt:
    ...Tumour shows HER2 over-expression (3+ by IHC and/or FISH + ) by testing of the primary tumour and if available the biopsied metastatic lesion 7....
    Trial ID:
    NCT01526369
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer

    Excerpt:
    ...- Patients with histologically confirmed breast cancer and overexpression of Her2neu....
    Trial ID:
    NCT00258960
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Effect of Trastuzumab on Disease Free Survival in Early Stage HER2-Negative Breast Cancer Patients With ERBB2 Expressing Disseminated Tumor Cells

    Excerpt:
    ...- Presence of bone marrow ERBB2 overexpressing DTCs at the time of diagnosis; bone marrow aspiration will be performed in consented patients to evaluate DTCs following pre-registration provided patients meet all eligibility criteria as described in this section....
    Trial ID:
    NCT01779050
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Safety and Efficacy of Trastuzumab as Part of Breast Cancer Treatment Regimen

    Excerpt:
    ...- HER2 over expression/amplification defined as either Immunohistochemistry (IHC)3+, or IHC2+ and Fluorescence in situ Hybridization (FISH) positive as determined in a central laboratory...
    Trial ID:
    NCT02419742
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A randomised phase II screening trial with functional imaging and patient reported toxicity sub-studies comparing LApatiNib plus capecitabine versus continued Trastuzumab plus capecitabine after local therapy in patients with ERb B2 positive metastatic breast cancer developing braiN metastasis /es

    Excerpt:
    ...ErbB2 overexpression in the invasive component of the primary or metastatic lesion as locally defined by: • 3+ staining by immunohistochemistry (IHC); • or 2+ staining by IHC in conjunction with ErbB2 gene amplification by FISH; • or ErbB2 gene amplification by FISH; Participants with a negative or equivocal overall result are not eligible for inclusion in the trial. ...
    Trial ID:
    2010-022737-28
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer

    Excerpt:
    ...- Local or central laboratory confirmedHER2/neu* overexpressing and/or amplified disease in the invasive component of the primary or metastatic lesion as defined by the following:...
    Trial ID:
    NCT00667251
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer

    Excerpt:
    ...Documentation of HER2 overexpression or gene amplification, in the invasive component of either the primary tumor or metastatic disease site as defined as:...
    Trial ID:
    NCT01160211
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    PHASE II STUDY OF LIPOSOME-ENCAPSULATED DOXORUBICIN PLUS PACLITAXEL AND TRASTUZUMAB AS PRIMARY SYSTEMIC THERAPY FOR OPERABLE AND LOCALLY-ADVANCED BREAST CANCER

    Excerpt:
    ...- Operable breast cancer patients (T>2 cm, cT2-3, N0-N2, M0) or potentially operable, locally advanced breast cancer patients (T4, N0-2, M0) or inflammatory breast cancer patients (T4d, N0-2, M0), with or without HER2 overexpression or amplificationu` - Hercept-test (DAKO) or FISH performed - Age > 18 and < 75 - ECOG performance status 0-1 - Life expectancy >3 months....
    Trial ID:
    2008-001369-27
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer

    Excerpt:
    ...- HER-2 overexpressing metastatic breast cancer cells confirmed by histology...
    Trial ID:
    NCT00426530
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast

    Excerpt:
    ...Comparison of proliferation rates of Her-2/neu overexpressing cells before and after treatment with Herceptin per Participant where absolute change defined as difference of increase/decrease. ...
    Trial ID:
    NCT00496808
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    GW572016 and Trastuzumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER2/Neu

    Excerpt:
    ...- HER2/neu overexpression (2+ or 3+) confirmed by immunohistochemistry and/or HER2 gene amplification by fluorescence in situ hybridization...
    Trial ID:
    NCT00085020
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Trastuzumab, Cyclophosphamide, and an Allogeneic GM-CSF-secreting Breast Tumor Vaccine for the Treatment of HER-2/Neu-Overexpressing Metastatic Breast Cancer

    Excerpt:
    ...Patients with histologically confirmed HER-2/neu-overexpressing adenocarcinoma of the breast; this is defined as HER-2+ by immunohistochemistry (IHC) 3+ staining or Fluorescence In-Situ Hybridization (FISH)....
    Trial ID:
    NCT00399529
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Paclitaxel With Trastuzumab and Lapatinib in HER2-Positive Early Stage Breast Cancer

    Excerpt:
    ...The primary objective of this trial is to determine the feasibility of this regimen in patients with node-negative HER-2/neu overexpressed /amplified breast cancer with a tumor size of < 3 cm. ...
    Trial ID:
    NCT01827163
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Intrathecal Trastuzumab Administration in Metastatic Breast Cancer Patients Developing Carcinomatous Meningitis

    Excerpt:
    ...- HER2 Overexpression by IHC and / or amplification (FISH and or ICHS) -...
    Trial ID:
    NCT01373710
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Studying Blood and DNA Samples From Patients With Breast Cancer Treated With Chemotherapy With or Without Trastuzumab

    Excerpt:
    ...• Patients with HER-2-overexpressing node-positive or high-risk node-negative breast cancer enrolled on NCCTG-N9831 * Pre- and post-treatment serum and DNA samples of patients treated with doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab (Herceptin®)...
    Trial ID:
    NCT01562288
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Preoperative Herceptin and Navelbine for Breast Cancer

    Excerpt:
    ...- HER2 overexpressing (IHC 3+ or FISH +)...
    Trial ID:
    NCT00148681
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Trastuzumab, Cyclophosphamide, and Vaccine Therapy in Treating Patients With High-Risk or Metastatic Breast Cancer

    Excerpt:
    ...- HER2/neu-overexpressing disease, defined as HER2/neu positive by IHC 3+ staining or by FISH+ amplification...
    Trial ID:
    NCT00847171
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Phase I Trial of Afatinib and Trastuzumab in HER2 Overexpressing Cancer.

    Excerpt:
    ...Patients with cancers overexpressing HER2 by Immunohistochemistry test( IHC) 3+ and/or IHC 2+ with positive gene amplification by FISH (confirmation on archived tissue needed) 3....
    Trial ID:
    NCT01649271
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Lapatinib Ditosylate, Trastuzumab, Paclitaxel, and Surgery in Treating Patients With Breast Cancer

    Excerpt:
    ...- Overexpression and/or amplification of HER2 is confirmed by immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) + when IHC 2+...
    Trial ID:
    NCT01688609
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Multimodality Treatment for Women With Stage II, Stage III, or Stage IV Breast Cancer

    Excerpt:
    ...- Adjuvant patients with at least 4 positive lymph nodes and HER-2 overexpressing tumor...
    Trial ID:
    NCT00006110
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Early Detection of Cardiac Toxicity of Trastuzumab (Herceptin ®) in Patients Treated for Breast Carcinoma: Value of Magnetic Resonance Imaging

    Excerpt:
    ...- Overexpression of HER2 in the invasive component of the primary tumor (3 + 2 + according to ICH or with confirmation of positivity by FISH or CISH)...
    Trial ID:
    MRTOX
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Lapatinib or Trastuzumab Given Prior to Surgery With Chemotherapy in Patients With Early Breast Cancer

    Excerpt:
    ...Over expression and/or amplification of ErbB2 in the invasive component of the primary tumour according to one of the following definitions....
    Trial ID:
    ELATE
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Gefitinib, Trastuzumab, and Docetaxel in Treating Patients With Metastatic Breast Cancer

    Excerpt:
    ...- HER-2/neu overexpression (3+ by immunohistochemistry OR 2+ by fluorescence in situ hybridization)...
    Trial ID:
    NCT00086957
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Neoadjuvant Herceptin in Patients With Breast Cancer

    Excerpt:
    ...- Her2/neu overexpressing tumors defined as HercepTest score of 3+, or >/= one-third of invasive tumor showing membranous staining, or fluorescence in situ hybridization (FISH) positive....
    Trial ID:
    NCT00133796
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Lapatinib +/- Trastuzumab In Addition To Standard Neoadjuvant Breast Cancer Therapy.

    Excerpt:
    ...- Have histologically or cytologically confirmed ErbB2- (HER2/neu-) overexpressing invasive breast cancer (T2-4, N0-2)....
    Trial ID:
    LPT109096
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study to Determine the Safety and Tolerability of Herceptin as an Adjuvant Therapy of Early Breast Cancer

    Excerpt:
    ...- Human Epidermal Growth Factor Receptor 2 (HER2)-neu overexpression...
    Trial ID:
    NCT02443467
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Dose Escalation Followed by Study of RAD001 in Combination With Trastuzumab in HER2-Positive Metastatic Breast Cancer

    Excerpt:
    ...- Primary tumor or metastasis must overexpress HER2...
    Trial ID:
    NCT00458237
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Epirubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab in Treating Women With HER2-Positive Stage III or Stage IV Breast Cancer

    Excerpt:
    ...- HER2 over-expressing tumor as assessed by immunohistochemistry and/or fluorescent in situ hybridization...
    Trial ID:
    NCT00379015
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Phase II Study of Rapamycin and Trastuzumab for Patients With HER-2 Receptor Positive Metastatic Breast Cancer

    Excerpt:
    ...- Histologically confirmed HER2 overexpressing (IHC 3+ and/or FISH +) metastatic breast cancer with measurable disease....
    Trial ID:
    NCT00411788
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Chemotherapy for Elderly Patients Diagnosed With Localized HER2 Positive Breast Cancer

    Excerpt:
    ...- HER2 overexpression or amplification defined by immunohistochemistry staining of +3 or positive fluorescence in situ hybridization (FISH) test....
    Trial ID:
    NCT02102438
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Experience of the Patient Treated With Trastuzumab (Herceptin ®) as Adjuvant for Breast Cancer

    Excerpt:
    ...- For the group Herceptin ®: HER2 overexpression without contraindication to treatment administration -...
    Trial ID:
    NCT01400438
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Herceptin (Trastuzumab) in Combination With 2nd-Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.

    Excerpt:
    ...- HER2 overexpression (IHC 3+ and/or FISH positive);...
    Trial ID:
    NCT00444587
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of AC Followed by a Combination of Paclitaxel Plus Trastuzumab or Lapatinib or Both Given Before Surgery to Patients With Operable HER2 Positive Invasive Breast Cancer

    Excerpt:
    ...In tumor tissue, a comparison of array comparative genomic hybridization (CGH) data with gene expression profile data to examine coordinated overexpression of amplified genes, especially in HER2 and cMYC loci....
    Trial ID:
    NSABP B-41
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer

    Excerpt:
    ...- Documented amplification of the ErbB2 gene by fluorescence in situ hybridization (FISH) or documented overexpression of the ErbB2 protein by IHC in primary or metastatic tumor tissue....
    Trial ID:
    NCT00320385
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Efficacy and Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer

    Excerpt:
    ...- HER-2 over-expressing metastatic breast cancer cells confirmed by histology...
    Trial ID:
    NCT00426556
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Docetaxel, Vinorelbine and Trastuzumab in the Treatment of Patients With Metastatic Her-2 Positive Breast Cancer

    Excerpt:
    ...feasibility and toxicity of the combination of weekly docetaxel, vinorelbine, and trastuzumab in patients with metastatic breast cancer who overexpress Her-2....
    Trial ID:
    NCT00193089
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    GW572016 For Treatment Of Refractory Metastatic Breast Cancer

    Excerpt:
    ...- Subjects with documented ErbB2 tumor overexpression must have received at least 6 cycles of trastuzumab....
    Trial ID:
    NCT00062686
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.

    Excerpt:
    ...- HER2/neu tumor overexpression...
    Trial ID:
    NCT00051103
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    GW572016, An Oral Drug For Women With Refractory Metastatic Breast Cancer After First-line Or Second-line Herceptin

    Excerpt:
    ...- Refractory Stage IIIb or IV breast cancer - HER2/neu tumor overexpression - Disease progression while receiving a prior chemotherapy regimen with Herceptin alone or in combination with other chemotherapy. ...
    Trial ID:
    NCT00044330
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Trastuzumab in Treating Women With Metastatic Breast Cancer

    Excerpt:
    ...- Primary tumor must overexpress HER2 (IHC 3+ OR IHC 2+ and FISH+ OR FISH+)...
    Trial ID:
    NCT00896376
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    THOR Study: A Study of Continued Herceptin (Trastuzumab) in Combination With Second Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.

    Excerpt:
    ...- HER2 overexpression (IHC 3+ and/or FISH positive);...
    Trial ID:
    NCT00448279
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Herceptin (Trastuzumab) in Combination With Whole Brain Radiotherapy in Patients With HER-2 Positive Breast Cancer

    Excerpt:
    ...- Diagnosis of breast carcinoma with HER-2 overexpression...
    Trial ID:
    NCT01363986
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Lapatinib Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy

    Excerpt:
    ...- Documented HER2 overexpression (IHC 3+ and/or FISH positive)...
    Trial ID:
    NCT00903656
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Celecoxib and Trastuzumab in Treating Women With Metastatic Breast Cancer

    Excerpt:
    ...- HER2/neu-positive (overexpressing) tumor tissue...
    Trial ID:
    NCT00006381
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    IRS Proteins and Trastuzumab Resistance

    Excerpt:
    ...Biopsy proven breast cancer with her 2 overexpression by fluorescence in situ hybridization (FISH)....
    Trial ID:
    NCT00657345
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women With Stage IV Breast Cancer

    Excerpt:
    ...- HER2/neu-overexpression (3+ by immunohistochemistry AND/OR gene amplification by fluorescence in situ hybridization)...
    Trial ID:
    NCT00398437
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Trastuzumab and Capecitabine in Treating Women With Metastatic Breast Cancer

    Excerpt:
    ...- HER2/neu overexpression...
    Trial ID:
    NCT00107393
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Vinorelbine With or Without Trastuzumab in Treating Women With Progressive Metastatic Breast Cancer

    Excerpt:
    ...- HER2 protein overexpression (3+) by immunohistochemistry...
    Trial ID:
    NCT00103233
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer

    Excerpt:
    ...- Human epidermal growth factor receptor 2 (HER2) overexpression....
    Trial ID:
    NCT00022672
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Interleukin-12, Paclitaxel, and Trastuzumab in Treating Patients With Solid Tumors

    Excerpt:
    ...- Histologically confirmed HER2/neu-overexpressing (2+ or 3+) malignancy by any standardized assay (fluorescence in-situ hybridization allowed)...
    Trial ID:
    NCT00028535
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Chemotherapy Plus Monoclonal Antibody Therapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Overexpresses HER2

    Excerpt:
    ...- Histologically confirmed stage II or IIIa (T1-T3, N1-N2, M0) adenocarcinoma of the breast HER2 overexpression (2-3+ by immunochemistry)...
    Trial ID:
    NCT00003992
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Chemotherapy Plus Trastuzumab in Treating Patients With Breast Cancer

    Excerpt:
    ...- HER-2/neu overexpression (1+ to 3+) -...
    Trial ID:
    NCT00014430
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of HER2/Neu

    Excerpt:
    ...- Patients must have a histologically proven Her2 overexpressing malignancy as determined by any standardized assay currently in clinical use...
    Trial ID:
    NCT00004074
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of Gemcitabine and Herceptin Versus Xeloda and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients

    Excerpt:
    ...- HER-2 overexpression 2+ or 3+ using IHC or FISH +...
    Trial ID:
    NCT00440622
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Trastuzumab and Gefitinib in Treating Patients With Metastatic Breast Cancer

    Excerpt:
    ...- Overexpression of HER2-neu (HER2 3+ by immunohistochemistry or gene amplification as measured by fluorescent in situ hybridization)...
    Trial ID:
    NCT00024154
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Dose Dense Carboplatin, Taxotere and Herceptin As Primary Systemic Therapy in Breast Cancer

    Excerpt:
    ...- HER-2 overexpressing breast cancer...
    Trial ID:
    NCT00232479
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Trastuzumab and External Beam Radiation Therapy in Treating Women With Stage III or Stage IV Breast Cancer

    Excerpt:
    ...- HER2-overexpressing tumor...
    Trial ID:
    NCT00943410
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer

    Excerpt:
    ...Histologically confirmed recurrent or metastatic breast cancer HER2-neu overexpressing tumor (2+ or 3+) Measurable or evaluable disease If bone disease only, must have lytic lesions...
    Trial ID:
    NCT00006104
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Trastuzumab in a Neo-adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study

    Excerpt:
    ...- Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to one of the following definitions:...
    Trial ID:
    TRAIN
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Monoclonal Antibody Plus Chemotherapy in Treating Patients With Metastatic Breast Cancer That Overexpresses HER2

    Excerpt:
    ...- Histologically or cytologically confirmed metastatic breast cancer with HER2 overexpression...
    Trial ID:
    NCT00019812
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients

    Excerpt:
    ...- HER-2 overexpression 2+ or 3+ using IHC or FISH +...
    Trial ID:
    NCT00453635
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer

    Excerpt:
    ...Histologically confirmed adenocarcinoma of the breast Metastatic disease HER2 overexpressing tumor (2+ or 3+) Bidimensionally measurable or evaluable disease...
    Trial ID:
    NCT00006108
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Trastuzumab in Treating Women With HER2-Positive Early Breast Cancer

    Excerpt:
    ...- Overexpression of HER2 receptor defined as 3+ or 2+ HER2 positivity measured by fluorescent in situ hybridization (FISH) gene amplification -...
    Trial ID:
    PERSEPHONE
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer

    Excerpt:
    ...- histologically confirmed metastatic breast cancer overexpressing HER2...
    Trial ID:
    NCT01423695
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer

    Excerpt:
    ...- Tumor that has overexpression of HER2 as documented by being either FISH-positive or HER2/neu 3+ confirmed by immunohistochemistry....
    Trial ID:
    NCT00031278
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Capecitabine, Oxaliplatin and Trastuzumab in Treating Patients With HER2 Positive Metastatic Breast Cancer

    Excerpt:
    ......
    Trial ID:
    NCT00216073
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer

    Excerpt:
    ...- HER-2/neu overexpression (3+ by immunohistochemistry OR gene amplification by FISH) -...
    Trial ID:
    NCT00006825
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    TBP Study With Capecitabine Plus Minus Trastuzumab

    Excerpt:
    ...HER2-overexpression of the primary or metastatic tumor tissue detected by immunohistochemistry (DAKO) 3+ or gene namplification detected by FISH....
    Trial ID:
    NCT00148876
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of the Efficacy and Safety of Letrozole Combined With Trastuzumab in Patients With Metastatic Breast Cancer

    Excerpt:
    ...- Her-2 overexpression and ER and/or PgR positive...
    Trial ID:
    eLEcTRA
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Trastuzumab in Combination With Vinorelbine or Taxane-Based Chemotherapy in Patients With Metastatic Breast Cancer

    Excerpt:
    ...- Tumors must be HER2 overexpressing...
    Trial ID:
    NCT00146549
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Trial for HER2 Positive Breast Cancer Patients With Metastatic Disease

    Excerpt:
    ...- Tumors tested by IHC must be 3+ positive for HER2 overexpression....
    Trial ID:
    NCT00191373
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A phase III randomized trial of trastuzumab continuation vs discontinuation in combination with 2nd-line chemotherapy after progression on a 1st-line trastuzumab-chemotherapy combination for HER2 overexpressing metastatic breast cancer patients.

    Excerpt:
    ...Documented diagnosis of metastatic breast carcinoma (stage IV) HER2 overexpressing (ICH 3+ or FISH +). ...
    Trial ID:
    2006-000703-42
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    ICORG 11-10 (TH v THL) A study to find out whether combining lapatinib treatment with trastuzumab and paclitaxel is more effective at slowing the growth of HER2 positive metastatic breast cancer, than using trastuzumab and paclitaxel alone.

    Excerpt:
    ...Tumor shows HER2 over-expression (3+ by IHC or FISH + or CISH) by testing of the primary tumour and if available the biopsied metastatic lesion. ...
    Trial ID:
    2011-005189-39
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A randomized, multicentre, open-label, Phase II study of the efficacy and safety of lapatinib plus epirubicin and cyclophosphamide (EC90-L) followed by weekly paclitaxel and lapatinib (PX-L) compared with EC90 followed by weekly paclitaxel and trastuzumab (PX-T), as neoadjuvant therapy in patients with previously untreated ErbB2-overexpressing Stage I - IIIA invasive breast cancer with primary tumour size > 1cm.

    Excerpt:
    ...Over expression and/or amplification of ErbB2 in the invasive component of theprimary tumour according to one of the following definitions. ...
    Trial ID:
    2010-018389-22
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Capecitabine, Cyclophosphamide, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With HER2-Positive Metastatic Breast Cancer

    Excerpt:
    ...- HER2 overexpression of tumor by either immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH); tumors tested by IHC must be 3+ positive; tumors tested by FISH must have a ratio of HER2: chromosome enumeration probe (CEP)17 > 2.0; when both tests are performed, the FISH result must be positive...
    Trial ID:
    NCT01873833
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Xenogeneic HER2/Neu DNA Immunization for Patients With Metastatic and High Risk Breast Cancer: A Phase I Study to Assess Safety and Immunogenicity

    Excerpt:
    ...- HER2 over-expression by FISH or by staining 3+ on immunohistochemistry in either the primary or metastatic tumor....
    Trial ID:
    NCT00393783
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    ErbB2 Over-expressing Metastatic Breast Cancer Study Using Paclitaxel, Trastuzumab, and Lapatinib

    Excerpt:
    ...- Had tumors that overexpress ErbB2 defined as either: 3+ by IHC OR c-erbB2 gene amplification by FISH OR 0, 1+, 2+ by IHC and c-erbB2 gene amplification by FISH....
    Trial ID:
    NCT00272987
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    GW572016 With Docetaxel and Trastuzumab for the Treatment Of Untreated ErbB2 Over-Expressing Metastatic Breast Cancer

    Excerpt:
    ...- Prior to enrolment in the Phase I part of the study, subjects must have documentation of ErbB2 over-expression via IHC3+ or FISH+ testing....
    Trial ID:
    NCT00251433
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    J Clin Oncol
    Title:

    Efficacy and Safety of Trastuzumab as a Single Agent in First-Line Treatment of HER2-Overexpressing Metastatic Breast Cancer

    Published date:
    03/15/2023
    Excerpt:
    One hundred fourteen women with HER2-overexpressing metastatic breast cancer were randomized to receive first-line treatment with trastuzumab...The objective response rate was 26% (95% confidence interval [CI], 18.2% to 34.4%), with seven complete and 23 partial responses. Response rates in 111 assessable patients with 3+ and 2+ HER2 overexpression by immunohistochemistry (IHC) were 35% (95% CI, 24.4% to 44.7%) and none (95% CI, 0% to 15.5%), respectively.
    DOI:
    10.1200/JCO.22.02516