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Association details:
| Biomarker: | HER-2 expression |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | Herceptin (trastuzumab) (HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Multicenter Clinical Trial in subjects with HER2-negative primary tumors. The subjects will be evaluated for the presence of HER2 positive Circulating Tumor Cells (CTCs) in blood. In case of at least one HER2-positive CTC in blood, the subject will be randomized to receive either (nabTM)-paclitaxel + trastuzumab (ARM A) or (nabTM)-paclitaxel (ARM B). Studio multicentrico in pazienti con tumori primari HER2 negativi. I pazienti saranno valutati per la presenza di cellule tumorali circolanti (CTC) HER2 positive nel sangue. In caso di positività di HER2 su almeno una CTC, il paziente sarà randomizzato per il trattamento con (nabTM)-paclitaxel + trastuzumab (BRACCIO A) oppure con (nabTM)-paclitaxel (BRACCIO B).
Excerpt:
...•To determine HER2 expression, proliferation index in fine needle aspirate (FNA) biopsies (optional). ...
Trial ID:
Source:
Title:
Letrozole, Herceptin in Her2neu +, Estrogen Receptor [ER] and/or Progesterone Receptor [PR] Positive, MBC
Excerpt:
...- Tumor cell expression of ER and/or PR and ErbB2....
Trial ID:
More C2 evidence
Source:
Title:
ANZ 0502 Neoadjuvant Gemcitabine
Excerpt:
...HER2 expression must be determined using either immunohistochemistry or FISH.• Patients with HER2 negative breast cancer must have a measured left ventricular ejection fraction of = 50% with MUGA or echocardiogram. ...
Trial ID:
Source:
Title:
Activity of trastuzumab based chemotherapy in metastatic breast patients with HER2-negative primary tumor but HER2 positive circulating tumor cells (CareMore-Trastuzumab)
Excerpt:
...Secondary endpoints are the association between 6 months PFR and PIK3CA mutation status, pHER2 expression and ER expression on CTC's. ...
Trial ID:
Source:
Title:
A single arm, prospective, multicenter study of pyrroltinib maleate combined with trastuzumab plus docetaxel plus carboplatin in the neoadjuvant treatment of HER2 positive breast cancer
Excerpt:
...For breast cancer patients with positive HER2 expression confirmed by pathological examination, positive HER2 expression refers to standard immunity histochemical (IHC) staining showed that HER2 was 3 + and / or positive by fluorescence in situ hybridization (FISH); 5. ...
Trial ID:
Source:
Title:
Study of 99mTc-HPArk2 SPECT/CT for Clinical Imaging of HER2 Positive Breast Cancer
Excerpt:
...Herceptin efficacy - Herceptin efficacy; HER2 expression - HER2 expression...
Trial ID:
Source:
Title:
Clinical Value of 89Zr-trastuzumab PET
Excerpt:
...Correlation of HER2-PET results and questionnaire results regarding clinical value of HER2-PET for the referring clinician`Correlation of HER2-PET results with standard conventional work-up`Correlation of HER2-PET results and HER-2 expression by CTCs...
Trial ID:
Source:
Title:
Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab
Excerpt:
...The HLA-A2 transfected human HER2/neu expressing breast cancer cell line, SKBR3-A2 T cells, expanded after stimulation with immunizing peptide, were added in an effector/target ratio of 40:1. ...
Trial ID:
Source:
Title:
Comparing the Efficacy of Nab-PHP and TCbHP in Neoadjuvant Therapy for HER2 Positive Operable Breast Cancer
Excerpt:
...HER2 expression positive refers to the tumor cells with immunohistochemical staining intensity of 3 + or confirmed positive by fluorescence in situ hybridization [fish] at least once during the pathological detection/review of primary tumor in the Department of pathology of participating research center hospital 4....
Trial ID:
Source:
Title:
Comparing the Efficacy of Nab-PH+Pyrrolitinib and TCbHP in the Neoadjuvant Treatment of HER2 Positive BC
Excerpt:
...HER2+, invasive breast cancer confirmed by histopathology;(HER2 positive expression means that there is at least one case of tumor cell immunohistochemical staining intensity of 3+or positive confirmed by fluorescence in situ hybridization [FISH] in the pathological test/review of the primary focus conducted by the Pathology Department of the Research Center Hospital)....
Trial ID:
Source:
Title:
89Zr-DFO*-Trastuzumab PET in Patients With Gastric or Breast Cancer - a Pilot Study
Excerpt:
...Whole blood pharmacokinetics (PK) of 89Zr-DFO*-trastuzumab (Maximum Plasma Concentration (Cmax) µg/mL)`Whole blood PK of 89Zr-DFO*-trastuzumab (AUC µg/mL × h)`Plasma PK of 89Zr-DFO*-trastuzumab (Cmax in µg/mL)`Plasma PK of 89Zr-DFO*-trastuzumab (AUC µg/mL × h)`Image-derived PK for 89Zr-DFO*-trastuzumab (µg/mL)`Literature-derived PK for unlabelled trastuzumab (Cmax in µg/mL)`Literature-derived PK for unlabelled trastuzumab (AUC in µg/mL × day)`Visual PET imaging analysis of tumor uptake of 89Zr-DFO*-trastuzumab and 89Zr-trastuzumab`Tumor-to-blood ratio of 89Zr-DFO*-trastuzumab (whole blood and plasma as well as image derived)`Tumor-to-image derived blood uptake ratio of 89Zr-trastuzumab`HER2 expression measured by IHC on tumor biopsies...
Trial ID:
Source:
Title:
Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study
Excerpt:
...Ratio (95% CI) of Geometric Means in p95HER2 Expression in HR Positive Patients With pCR vs no pCR`Percentage of Participants With Circulating Tumor Cells (CTC) in the Bloodstream...
Trial ID:
Source:
Title:
A Multi-Center Study of Lapatinib in Patients With Trastuzumab-refractory Metastatic Breast Cancer
Excerpt:
...- HER2-expressing primary or metastatic tumor...
Trial ID:
Source:
Title:
Trastuzumab or Lapatinib Ditosylate in Treating Women With Early Breast Cancer
Excerpt:
...Changes in the angiogenic serum markers VEGF-A, VEGF R1, and CD105, measured at diagnosis, surgery (plus also tumor CD31) and 28-30 days post surgery (biological phase)`Pre-treatment and/or surgical expression of molecular markers (EGFR, Her-3, IGF1R, c-myc, AKT, p-ERK, pS6 inase, activated src, or truncated p95HER-2 expression)`Time to local recurrence (clinical phase)`Time to distant recurrence (clinical phase)`Overall survival (clinical phase)...
Trial ID:
Source:
Title:
Efficacy and Safety of IPI-504 With Trastuzumab Pretreated, Locally Advanced or Metastatic HER2 Positive Breast Cancer
Excerpt:
...- HER2-expressing primary or metastatic tumor...
Trial ID:
Source:
Title:
[89Zr]trastuzumab PET/CT imaging of HER2 positive breast cancer for predicting pathologic complete response after neoadjuvant chemotherapy; A multicentre study
Excerpt:
...- Assess agreement between PET/CT-imaging signal in the tumor and axilla, histopathologic evidence of tumor and HER2 expression....
Trial ID:
Source:
Title:
A prospective phase II clinical study of pyrrotinib maleate combined with vinorelbine beats in the treatment of HER2-positive advanced breast cancer failed trastuzumab
Excerpt:
...Pathologically confirmed HER2 expression-positive recurrent/metastatic breast cancer patients; the standard for HER2 expression positive is immunohistochemical staining (IHC) detection of HER2 3+ and/or fluorescent in situ hybridization (FISH) positive The researcher of the test center reviewed and confirmed). ...
Trial ID:
Less C2 evidence
Source:
Title:
HER2 protein expression level is positively associated with the efficacy of neoadjuvant systemic therapy in HER2-positive breast cancer
Published date:
04/16/2022
Excerpt:
167 HER2-positive breast cancer patients who had received neoadjuvant chemotherapy containing trastuzumab were included in this study.... Multivariate analysis showed that HER2 protein expression was an independent predictive factor for pCR (OR=5.353, 95% CI 1.649-17.379, p = 0.005).... For HER2-positive breast cancer patients, the HER2 protein expression level detected by IHC may be a good predictive factor for the efficacy of neoadjuvant chemotherapy.
Secondary therapy:
Chemotherapy
DOI:
10.1016/j.prp.2022.153900
Source:
Title:
Gene expression profiling involved in response to neoadjuvant therapy in breast cancer.
Published date:
05/28/2020
Excerpt:
...patients with the Her2+ subtype received treatment with taxanos-trastuzumab and anthracyclines….In ER/PR+ Her2+ subgroup, NBPF4 showed a differential expression in R (n = 8) vs NR (n = 7). In pts with ER/PR- Her2+, nine genes (DHRS2, SLCO1B3, UGT2B15, RGS2, SULT1E1, MED23, FKBP5, MIEN1, HER2) were differentially expressed in R (n = 10) vs NR (n = 7).
Secondary therapy:
Chemotherapy
DOI:
10.1200/JCO.2020.38.15_suppl.e12618
Source:
Title:
84P - Actual 5-year survival of dose-dense sequential adjuvant chemotherapy in early breast cancer (BC) patients treated in the post-trastuzumab era: A pooled analysis of 3 clinical trials
Published date:
05/24/2020
Excerpt:
In total, 59.7% of pts had Hormone receptor (HR)(+)/HER2(-)(luminal) tumors, 25.5% had HER2(+) disease, and 14.5% had triple-negative breast cancer (TNBC). T was administered in 95.5% of pts with HER2(+) disease...The 5-year OS rate was 93% for pts with HER2(+) disease, 92% for luminal and 87% for TNBC.
Secondary therapy:
Chemotherapy
Source:
Title:
HER2 protein expression level is positively associated with the efficacy of neoadjuvant systemic therapy in HER2-positive breast cancer
Excerpt:
167 HER2-positive breast cancer patients who had received neoadjuvant chemotherapy containing trastuzumab were included in this study...The overall pCR rate was 43.7% (73/167). The pCR rate in the HER2 3 + group was significantly higher than in the HER2 2 + group (47.9% versus 22.2%, p = 0.014). After propensity score matching, 26 patients in the HER2 2 + group and 59 patients in the HER2 3 + group were matched...
DOI:
https://www.sciencedirect.com/science/article/abs/pii/S0344033822001443
