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Association details:
| Biomarker: | HER-2 overexpression |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | Herceptin (trastuzumab) (HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Excerpt:
HERCEPTIN SC is indicated for the treatment of HER2-positive locally advanced breast cancer...in combination with neoadjuvant chemotherapy followed by adjuvant HERCEPTIN
Secondary therapy:
Aromatase inhibitor
Source:
Title:
Biomarker Data From the Phase III KATHERINE Study of Adjuvant T-DM1 Versus Trastuzumab for Residual Invasive Disease After Neoadjuvant Therapy for HER2-Positive Breast Cancer
Published date:
02/02/2023
Excerpt:
CONTRADICTING EVIDENCE: In KATHERINE, adjuvant T-DM1 reduced risk of disease recurrence or death by 50% compared with trastuzumab in patients with residual invasive breast cancer...High versus low HER2 gene expression in residual disease was associated with worse outcomes with trastuzumab (HR, 2.02; 95% confidence interval [CI], 1.32–3.11)...
DOI:
https://doi.org/10.1158/1078-0432.CCR-22-1989
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:
More C2 evidence
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:
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:
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:
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:
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:
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:
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:
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 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:
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:
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:
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:
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:
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:
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:
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:
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:
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:
Source:
Title:
Celecoxib and Trastuzumab in Treating Women With Metastatic Breast Cancer
Excerpt:
...- HER2/neu-positive (overexpressing) tumor tissue...
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:
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:
Preoperative Herceptin and Navelbine for Breast Cancer
Excerpt:
...- HER2 overexpressing (IHC 3+ or FISH +)...
Trial ID:
Source:
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:
Source:
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:
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:
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:
IRS Proteins and Trastuzumab Resistance
Excerpt:
...Biopsy proven breast cancer with her 2 overexpression by fluorescence in situ hybridization (FISH)....
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:
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:
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:
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:
Source:
Title:
Capecitabine, Oxaliplatin and Trastuzumab in Treating Patients With HER2 Positive Metastatic Breast Cancer
Excerpt:
......
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:
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:
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:
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:
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:
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:
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:
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:
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:
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:
Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer
Excerpt:
...- ErbB2(HER2)overexpressing breast cancer....
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:
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:
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:
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:
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:
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:
Termination of trastuzumab-based treatment after complete response in HER2-positive metastatic breast cancer
Published date:
11/17/2020
Excerpt:
...patients with HER2 positive metastatic breast cancer received long-term trastuzumab...All patients had a pathological HER2 overexpressed tumor that scored 3+ (71.3%) by immunohistochemistry (IHC) or scored 2+ (28.7%) by IHC confirmed with FISH...A complete response was detected at 60 (75%) of the patients....After termination of trastuzumab, at a median follow-up 44.7 months (range, 11.6-66.6), recurrence was not detected in the patients...
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:
In addition to standard chemotherapy, 105 patients (66%) received neoadjuvant Trastuzumab/Pertuzumab dual therapy, 47 (29%) received Trastuzumab alone...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:
Intrinsic subtypes of HER2-positive breast cancer and their associations with pathologic complete response (pCR) and outcomes: Findings from NSABP B-41, a randomized neoadjuvant trial.
Published date:
05/16/2018
Excerpt:
In HER2-E, patients on trastuzumab-based arms had higher pCR than those on the lapatinib arm (67% vs 49%, p = 0.02).
DOI:
10.1200/JCO.2018.36.15_suppl.580
Trial ID:
