^
Association details:
| Biomarker: | HER-2 amplification |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | Herceptin (trastuzumab) (HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Four-Year Follow-Up of Trastuzumab Plus Adjuvant Chemotherapy for Operable Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Joint Analysis of Data From NCCTG N9831 and NSABP B-31
Excerpt:
Women randomly assigned to the trastuzumab arm had a significantly increased DFS (P < .001; stratified hazard ratio [HR], 0.52; 95% CI, 0.45 to 0.60; Fig 2A) and OS (P < .001; stratified HR, 0.61; 95% CI, 0.50 to 0.75; Fig 2B) compared with women randomly assigned to the control arm.
Secondary therapy:
ACT
DOI:
10.1200/JCO.2011.35.0868
Source:
Title:
Capecitabine, Vinorelbine, and Trastuzumab in Treating Patients With Metastatic Breast Cancer
Excerpt:
...- HER2/neu-positive by immunohistochemistry (3+ by HercepTest^™ or equivalent) OR positive for amplification by fluorescent in situ hybridization...
Trial ID:
Source:
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:
More C2 evidence
Source:
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:
Source:
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:
Source:
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:
Source:
Title:
A prospective study with beta-blockers and ACE-inhibitors in patients operable breast cancer experiencing mild cardiac toxicity during treatment with anthracycline and/or trastuzumab Studio prospettico sull'utilizzo della terapia cardiologica con beta-bloccanti ed ace-inibitori in pazienti con tumore mammario operabile e cardiotossicita' lieve da trattamento con antracicline e/o trastuzumab
Excerpt:
...Women older than 18 years; Women with histological diagnosis of invasive breast cancer completely removed by surgery (any T, any N, M0); Women eligible for adjuvant and/or neoadjuvant treatment with anthracyclines and/or trastuzumab; Patients with HER-2 positive tumors assessed by immunohistochemistry and/or Fluorescent in Situ Hybridization (FISH); Adequate hematopietic, hepatic and renal function; Normal cardiac function with LVEF ³ 55% at the baseline; Signed informed consent Donne di età ≥ 18 anni Diagnosi istologica di tumore della mammella operabile (qualunque T, qualunque N, M0); Iperespressione del gene HER2 valutata mediante test immunoistochimico (DAKO HercepTest) o amplificazione del gene HER 2 valutata con esame FISH (Fluorescent in Situ Hybridization). ...
Trial ID:
Source:
Title:
Phase II study evaluating the combination of liposomal doxorubicin plus cyclophosphamide with trastuzumab followed by docetaxel plus trastuzumab as therapy to be performed before surgery (neoadjuvant chemotherapy) for patients with breast cancer more than 2 cm in size and possible involvement of the lymph nodes adjacent and with the receptor HER2 positive. Studio di fase II che valuta l'associazione della doxorubicina liposomiale più il ciclofosfamide con il trastuzumab, seguita da docetaxel più trastuzumab, come terapia da eseguire prima dell'intervento chirurgico (neoadiuvante) per pazienti con tumore della mammella di dimensioni oltre i 2 cm ed eventuale coinvolgimento dei linfonodi limitrofi e con il recettore HER2 positivo.
Excerpt:
...HER2-positive (immunohistochemistry (IHC 3 +) or amplification detected by fluorescence in situ hybridization [FISH +]) - Age >18 - Performance status ECOG 0-1 - Life expectancy> 3 months - Neutrophils ≥ 1.5 x 10 9 / L and PLatelets ≥ 100 x 10 9 /L - Total bilirubin ≤ 1.5 times upper normal limit (UNL) of the Centre - ASAT (GOT) and / or ALT (GPT) ≤ 2.5 UNL - Alkaline phosphatase ≤ 5 UNL (unless they are bones metastases in the absence of any liver disease. ...
Trial ID:
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:
Doxorubicin and Cyclophosphamide Followed by Paclitaxel, Trastuzumab, and Lapatinib in Treating Patients With HER2/Neu-Overexpressed Breast Cancer
Excerpt:
...The number of patients who completed all planned therapy (dose-dense adjuvant/ neoadjuvant chemotherapy regimen) in HER-2/neu-overexpressed/ amplified breast cancer patients.`...
Trial ID:
Source:
Title:
Phase I Open Label Trial to Assess Safety of BIBW 2992 (Afatinib) in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.
Excerpt:
...Advanced or metastatic breast cancer that over-expresses HER2 (immunohistochemistry 3+ or 2+ and gene amplification by FISH)....
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:
Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients
Excerpt:
...Histologically confirmed HER 2 positive (defined as FISH amplification ratio more than 2.2) invasive carcinoma of the breast (primary tumor at diagnosis) with locally recurrent or metastatic disease....
Trial ID:
Source:
Title:
Delayed Adjuvant Herceptin® Treatment in Patients With HER-2 Positive Breast Cancer
Excerpt:
...HER-2 amplified (FISH +) determination in 2004 or thereafter....
Trial ID:
Source:
Title:
NK Cell Infusions With Trastuzumab for Patients With HER2+ Breast and Gastric Cancer
Excerpt:
...Histologically confirmed diagnosis of HER2-positive breast or gastric cancer (defined as IHC 3+ or HER2 FISH amplification ratio >2.2) 3....
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 Value of 89Zr-trastuzumab PET
Excerpt:
...- HER2 immunohistochemical score of 2+ and positive FISH for HER2/c-erbB2 amplification....
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:
Trastuzumab or Observation After Combination Chemotherapy and Trastuzumab in Treating Patients Undergoing Surgery for Stage II or Stage III Breast Cancer
Excerpt:
...- HER2/neu amplification by fluorescence in situ hybridization (FISH)...
Trial ID:
Source:
Title:
Vinorelbine With or Without Trastuzumab in Treating Women With Progressive Metastatic Breast Cancer
Excerpt:
...- HER2 gene amplification by fluorescence in situ hybridization...
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:
Phase III Clinical Trial Comparing the Safety, Efficacy, and Immunogenicity of HS022 and Trastuzumab® in Combination With Vinorelbine Bitartrate Injection in the Treatment of HER2-positive Breast Cancer
Excerpt:
...For those IHC score 2+ patients, fluorescence in situ hybridization (FISH), chromogenic in situ hybridization (CISH) or silver enhanced in situ hybridization (SISH) should be tested to prove HER2 gene amplification....
Trial ID:
Source:
Title:
A Clinical Study on Hormone Receptor Positive HER2 Positive Breast Cancer of RCB1-2 After Neoadjuvant Treatment With Trastuzumab Combined With Parezumab
Excerpt:
...histologically confirmed invasive breast cancer; After receiving the new adjuvant treatment and completing the surgery, the pathology showed that there was residual invasive cancer in the breast or axillary lymph nodes and the RCB rating was 1-2; HER2 pathological test result is positive, which is defined as the result of immunohistochemistry (IHC) test is 3+or the result of in situ hybridization (ISH) is HER2 gene amplification (HER2/CEP17 ≥ 2.0 or average HER2 copy number/cell ≥ 6); There was...
Trial ID:
Source:
Title:
ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D
Excerpt:
...- Over expression and/or amplification of HER2 in the invasive component of the primary tumour (in case of neoadjuvant treatment, tissue sample used for HER2 testing should be collected before neoadjuvant treatment starts), according to one of the following definitions [Wolff et al 2007] and confirmed by central laboratory prior to randomization:...
Trial ID:
Source:
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:
Source:
Title:
Neoadjuvant 5-fluorouracil, Epirubicin and Cyclophosphamide (FEC) Followed by Weekly Paclitaxel and Trastuzumab in Her2 Positive Breast Cancer
Excerpt:
...Over expression and/or amplification of HER2 in the invasive component of the primary tumour according to one of the following definitions: 7....
Trial ID:
Source:
Title:
Trastuzumab in Treating Older Women With Early-Stage Breast Cancer
Excerpt:
...- Immunohistochemical staining for Her2 protein of 3+ intensity or Her2 gene amplification of ≥ 2.0 by FISH testing....
Trial ID:
Source:
Title:
Stage I HER2 Positive Invasive Breast Cancer De-escalation Study(IRIS)
Excerpt:
...HER-2 (3+) or HER-2 (0-2 +) with FISH detection is amplified;...
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:
CharactHer. ICORG 12-09, V3
Excerpt:
...HER2-positivity defined as score 3+ on IHC and/or with HER2/neu amplification on FISH test (HER2/CEP17 ratio >2.0 on PathVysion test) 3....
Trial ID:
Source:
Title:
VinCaT: Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer
Excerpt:
...- Overexpression of HER-2 (immunohistochemistry 3+) or genetic amplification of c-erbB2/neu (FISH+)...
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:
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:
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:
Phase 2 Study of Trastuzumab and Etoposide for Her2 Positive Breast Cancer
Excerpt:
...- Confirmed HER2 amplification by immunohistochemical staining (IHC) 3+ or FISH amplified (either primary or metastatic)....
Trial ID:
Source:
Title:
Study of the Combination of KD019 and Trastuzumab in Subjects With HER2-Positive Metastatic Breast Cancer
Excerpt:
...HER2 positive is defined as 3+ staining by immunohistochemistry, or HER2 gene amplification by fluorescent in situ hybridization (FISH) or silver in situ hybridization (SISH) with HER2/CEP17 ratio ≥ 2.0....
Trial ID:
Source:
Title:
Efficacy and Safety of Adjuvant Docetaxel and Trastuzumab in Stage I HER2-positive Breast Cancer
Excerpt:
...HER-2 positive: immuno-histochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) confirmed amplification of erbb2 gene; 4....
Trial ID:
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:
Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study
Excerpt:
...- Over expression and/or amplification of HER2 in the invasive component of the primary tumour [Wolff et al 2006] and confirmed by a certified laboratory prior to randomisation...
Trial ID:
Source:
Title:
Stage I HER2 Positive Invasive Breast Cancer De-escalation Study(IRIS-C/D)
Excerpt:
...HER-2 (3+) or HER-2 (0-2 +) with FISH detection is amplified;...
Trial ID:
Source:
Title:
Paclitaxel With Trastuzumab and Lapatinib in HER2-Positive Early Stage Breast Cancer
Excerpt:
...- Patients must have histologically confirmed adenocarcinoma with HER2/neu immunohistochemistry 3+ or FISH-amplified breast cancer with a ratio of ≥ 2.0...
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:
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:
Trastuzumab and Letrozole in Treating Postmenopausal Women With Progressive Advanced Breast Cancer
Excerpt:
...- HER-2 amplification ≥ 2 by fluorescence in situ hybridization...
Trial ID:
Source:
Title:
Trastuzumab and Vinorelbine in Advanced Breast Cancer
Excerpt:
...- Patients must have CTCs with HER2 amplification by 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:
Trastuzumab or Lapatinib Ditosylate in Treating Women With Early Breast Cancer
Excerpt:
...- HER2-positive disease, defined as 3+ measured by IHC or gene amplification by fluorescent in situ hybridization (FISH)...
Trial ID:
Source:
Title:
A Study of Patients With HER2 Gene Amplified Metastatic Breast Cancer Treated With First Line Herceptin and a Taxane
Excerpt:
...- Histologically confirmed, measurable or nonmeasurable but evaluable, HER2 positive metastatic breast cancer (HER2 positive is defined as 3+ staining by IHC or gene amplification by FISH, determined by the local or central laboratory)...
Trial ID:
Source:
Title:
Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women
Excerpt:
...- 2 positive on IHC with HER2 gene amplification on FISH or SISH using a single-probe or dual-probe...
Trial ID:
Source:
Title:
Trastuzumab and Irinotecan in Treating Patients With HER2/Neu Positive Metastatic Breast Cancer
Excerpt:
...- Confirmation of HER2/neu status by a positive test for gene amplification by fluorescence in situ hybridization or 3+ by immunohistochemistry -...
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:
Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy in HER2-positive Breast Cancer
Excerpt:
...- Over expression and/or amplification of HER2 in the invasive component of the primary tumour [Wolff et al 2006] and confirmed by a certified laboratory prior to randomisation...
Trial ID:
Source:
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:
Source:
Title:
Capecitabine, Oxaliplatin and Trastuzumab in Treating Patients With HER2 Positive Metastatic Breast Cancer
Excerpt:
...- HER2 gene amplification by FISH....
Trial ID:
Source:
Title:
TBP Study With Capecitabine Plus Minus Trastuzumab
Excerpt:
......
Trial ID:
Source:
Title:
A Trial for HER2 Positive Breast Cancer Patients With Metastatic Disease
Excerpt:
...Tumors tested by FISH must be positive by the specific FISH assay for genetic amplification of HER2....
Trial ID:
Source:
Title:
Phase III Clinical Trial Comparing the Safety, Efficacy, and Immunogenicity of HS022 and Trastuzumab in Combination With Vinorelbine Bitartrate Injection in the Treatment of HER2-positive breast cancer
Excerpt:
......
Trial ID:
Source:
Title:
A randomized, open label, multicenter, phase II study for comparing docetaxel + carboplatin + trastuzumab versus docetaxel + trastuzumab sequential epirubicin + cyclophosphamide + trastuzumab in the neoadjuvant therapy of patient with early or locally advanced HER2 positive mammary glands cancer
Excerpt:
...Breast cancer meets the following criteria: - histologically confirmed invasive breast cancer, primary tumor diameter determined by local standard assessment method >2 cm tumor stage: early (T2-3, N0-1, M0) or locally advanced (T2-4, N2 or N3, M0); - Pathologically confirmed HER2 positive breast cancer, defined as >10% immunoreactive cells with immunohistochemistry (IHC) score of 3+ or in situ hybridization (ISH) results for HER2 gene amplification (HER2 gene signaling and centromere The ratio of the granule 17 signal is Ratio ≥ 2.0 or the ratio of the HER2 gene is ≥ 6); - known hormone receptor status (ER and PgR); The Eastern Tumor Collaborative Group (ECOG) has a physical status score of ≤1; Complete all necessary baseline laboratory measurements and imaging studies prior to randomization, meeting the following requirements (no blood transfusion within 2 weeks prior to screening, no use of leukocytes, platelet-up drugs): 1) blood routine test: Neutrophils (ANC) ≥ 1.5 × 10^9/L; platelet count (PLT) ≥ 90 × 10^9/L; hemoglobin (Hb) ≥ 90g/L; 2) Blood biochemistry: Total bilirubin (TBIL) ≤ 1.5 upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) Heart color ultrasound: Left ventricular ejection fraction (LVEF) ≥ 55%; 4) The QT interval (QTcF) corrected by the 12-lead electrocardiogram Fridericia method is ...
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:
Efficacy and Safety of Fixed-Dose Trastuzumab (Henlius) in Neoadjuvant Therapy for HER2-positive Breast Cancer
Excerpt:
...Female, 18-65 years old, diagnosed as breast cancer, with negative immunohistochemical hormone receptor (ER -, PR -), HER2+++or HER2++FISH detection indicating HER2 amplification; 2. ...
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:
Phase II randomised, open-label, unicentric clinical trial of neoadjuvant treatment comprising chemotherapy and trastuzumab with or without metformin, in women with HER2/ErbB2 positive primary breast cancer. Ensayo fase II, aleatorizado, abierto, unicéntrico, de tratamiento neoadyuvante con quimioterapia y trastuzumab con o sin la adición de metformina en mujeres diagnosticadas de cáncer de mama primario HER2/ErbB2 positivo.
Excerpt:
...Over-expression and/or amplification of HER2 in the invasive component of the primary tumour, defined according to the following criteria: - 3+ score by IHC - 2+ score by IHC and positive FISH/CISH 6. ...
Trial ID:
Source:
Title:
Single-arm, single-center clinical trial of pyrrottinib in combination with albumin paclitaxel, carboplatin, and trastuzumab neoadjuvant therapy for HER2-positive early or locally advanced breast cancer
Excerpt:
......
Trial ID:
Less C2 evidence
Source:
Title:
The benefits of trastuzumab in the treatment of HER2+ breast cancer as a function of exposure time
Published date:
01/20/2022
Excerpt:
The median time of survival (50%) was achieved only for patients with up to 63 days/no exposure to Trastuzumab regarding DFS (133.23 months)….The administration of trastuzumab improves survival in non-metastatic breast cancer patients, and is the main therapy for managing HER2-positive overexpressing/amplified tumours.
DOI:
https://doi.org/10.3332/ecancer.2022.1347
Source:
Title:
Pathologic and molecular responses to neoadjuvant trastuzumab and/or lapatinib from a phase II randomized trial in HER2-positive breast cancer (TRIO-US B07)
Published date:
11/17/2020
Excerpt:
In this multicenter, open-label, randomized phase II investigator-sponsored neoadjuvant trial with funding provided by Sanofi and GlaxoSmithKline (TRIO-US B07, Clinical Trials NCT00769470), participants with early-stage HER2-positive breast cancer (N = 128) were recruited...Participants were randomized to receive trastuzumab (T; N = 34), lapatinib (L; N = 36), or both (TL; N = 58) as HER2-targeted therapy...we observed similar pCR rates between T (47%, 95% confidence interval [CI] 30-65%) and TL (52%, 95% CI 38-65%), and a lower pCR rate with L (25%, 95% CI 13-43%)...Higher-level amplification of HER2 and hormone receptor (HR)-negative status were associated with a higher pCR rate.
DOI:
10.1038/s41467-020-19494-2
Trial ID:
Source:
Title:
P55: The Degree of HER2 Protein Overexpression and Gene Amplification is Associated with the Extent of Response to Neoadjuvant Therapy
Published date:
08/17/2020
Excerpt:
For patients with HER2+ breast cancer who undergo NAT, the degree of HER2 protein overexpression and gene amplification were associated with response to NAT.
Source:
Title:
Correlation between HER2 amplification level and response to neoadjuvant treatment with trastuzumab and chemotherapy in HER2 positive breast cancer.
Published date:
05/28/2020
Excerpt:
Pathological Complete Response (pCR) (Miller-Payne grading system) was obtained in 58% of the patients whose tumors showed amplification. No pCR was obtained in the 8 patients whose tumors were negative by FISH (not amplified)....We also demonstrated an association between the HER2 amplification level (both ratios and numbers of HER2 signals) and a trend toward improved disease free survival (DFS) (p = 0.451 and p= 0.619, respectively).
DOI:
10.1200/JCO.2020.38.15_suppl.e12641
Test:
Source:
Title:
ERBB2 and PTPN2 g ene copy numbers as prognostic factors in HER2-positive metastatic breast cancer treated with trastuzumab
Excerpt:
Patients with tumours displaying a high-grade ERBB2 (HER2) amplification level of ≥6 copies had a significantly improved overall survival hazard ratio [(HR)=0.4; 95%, confidence interval (CI): 0.2-0.9] and progression-free survival (HR=0.3; 95% CI: 0.1-0.7) compared with patients with tumours harbouring fewer ERBB2 copies.
DOI:
10.3892/ol.2019.9998
