Association details:
| Biomarker: | HER-2 overexpression |
|---|---|
| Cancer: | Breast Cancer |
| Drug: | Herceptin (trastuzumab) (HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
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
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
Source:
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
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
Source:
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:
Source:
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:
More C2 evidence
Source:
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:
Source:
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:
Source:
Title:
Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer
Excerpt:
...- ErbB2(HER2)overexpressing breast cancer....
Trial ID:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
Title:
Cardiotoxicity of Adjuvant Trastuzumab
Excerpt:
...- Histologically confirmed, completely excised invasive breast cancer with Her-2 overexpression...
Trial ID:
Source:
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:
Source:
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:
Source:
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:
Source:
Title:
Vinorelbine With or Without Trastuzumab in Treating Women With Progressive Metastatic Breast Cancer
Excerpt:
...- HER2 protein overexpression (3+) by immunohistochemistry...
Trial ID:
Source:
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:
Source:
Title:
Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer
Excerpt:
...- Primary invasive breast cancers that overexpress the HER2/neu oncogene...
Trial ID:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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....
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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....
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
Title:
Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer
Excerpt:
...- Patients with histologically confirmed breast cancer and overexpression of Her2neu....
Trial ID:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
Title:
Preoperative Herceptin and Navelbine for Breast Cancer
Excerpt:
...- HER2 overexpressing (IHC 3+ or FISH +)...
Trial ID:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
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:
Source:
Title:
Safety of Herceptin/Trastuzumab in Metastatic Breast Cancer
Excerpt:
...- Confirmed diagnosis of metastatic breast cancer (BC) with HER2-neu overexpression...
Trial ID:
Source:
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:
Source:
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:
Source:
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....
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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....
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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....
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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...
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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....
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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. ...
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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....
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Title:
Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.
Excerpt:
...- HER2/neu tumor overexpression...
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Title:
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer
Excerpt:
...- HER2 overexpression;...
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Title:
Trastuzumab in Treating Women With Metastatic Breast Cancer
Excerpt:
...- Primary tumor must overexpress HER2 (IHC 3+ OR IHC 2+ and FISH+ OR FISH+)...
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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...
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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)...
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Title:
Celecoxib and Trastuzumab in Treating Women With Metastatic Breast Cancer
Excerpt:
...- HER2/neu-positive (overexpressing) tumor tissue...
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Title:
IRS Proteins and Trastuzumab Resistance
Excerpt:
...Biopsy proven breast cancer with her 2 overexpression by fluorescence in situ hybridization (FISH)....
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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)...
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Title:
Trastuzumab and Capecitabine in Treating Women With Metastatic Breast Cancer
Excerpt:
...- HER2/neu overexpression...
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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....
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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)...
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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)...
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Title:
Chemotherapy Plus Trastuzumab in Treating Patients With Breast Cancer
Excerpt:
...- HER-2/neu overexpression (1+ to 3+) -...
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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...
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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)...
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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:
......
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Title:
Dose Dense Carboplatin, Taxotere and Herceptin As Primary Systemic Therapy in Breast Cancer
Excerpt:
...- HER-2 overexpressing breast cancer...
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Title:
Trastuzumab and External Beam Radiation Therapy in Treating Women With Stage III or Stage IV Breast Cancer
Excerpt:
...- HER2-overexpressing tumor...
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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...
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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....
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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:...
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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...
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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 +...
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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 -...
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Title:
Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer
Excerpt:
...- histologically confirmed metastatic breast cancer overexpressing HER2...
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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....
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Title:
Capecitabine, Oxaliplatin and Trastuzumab in Treating Patients With HER2 Positive Metastatic Breast Cancer
Excerpt:
......
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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) -...
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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...
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Title:
Trastuzumab in Combination With Vinorelbine or Taxane-Based Chemotherapy in Patients With Metastatic Breast Cancer
Excerpt:
...- Tumors must be HER2 overexpressing...
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Title:
A Trial for HER2 Positive Breast Cancer Patients With Metastatic Disease
Excerpt:
...- Tumors tested by IHC must be 3+ positive for HER2 overexpression....
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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. ...
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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. ...
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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:
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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...
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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:
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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. ...
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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. ...
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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. ...
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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:
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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:
......
Trial ID:
Source:
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:
Source:
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:
Less C2 evidence
Source:
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
