Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Preoperative Study With Trastuzumab, Pertuzumab and Letrozole in Breast Cancer Patients Sensitive to Hormonal Therapy
Excerpt:...- HR positivity (ER ≥ 10% and/or PgR ≥10%) and HER2 positivity (IHC 3+ or FISH/CISH amplification), as assessed by local laboratory....
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
The use of FES-PET imaging as a tool to detect a possible reversion of Estrogen Receptor (ER)-α status in patients with metastatic breast cancer HER2 + and ERα neg treated with trastuzumab + pertuzumab + taxane. La TEP-FES comme outil de détection d'une possible réversion du statut REα chez des patientes présentant un cancer du sein métastatique HER2+ et REα neg traitées par trastuzumab + pertuzumab + taxane.
Excerpt:...Patient with metastatic breast cancer HER2 + (IHC+++ and/or HER2 amplification in ISH according to ASCO recommendations), ERα neg (0% in IHC) and Progesterone Receptor neg (0% in IHC). ...
More C2 evidence
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Imaging With 111 Indium (111In)-Pertuzumab (PmAb) to Predict Response to Trastuzumab (TmAb) in Human Epidermal Growth Factor-2 (HER2) Positive Metastatic Breast Cancer (MBC) or Locally Advanced Breast Cancer (LABC)
Excerpt:...Tumour HER2 positive by immunohistochemistry for HER2 protein over-expression or by Fluorescence in situ Hybridization (FISH) for HER2 gene amplification, as defined by American Society of Clinical Oncology/College of American Pathologists guidelines 3....
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2
Excerpt:...- Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to one of the following definitions: •>30% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+) •HER2 gene amplification defined as >6 HER2 gene copies per nucleus by in situ hybridization....
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Pertuzumab, Trastuzumab, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With HER2-Positive Advanced Breast Cancer
Excerpt:...- Tumor positive or negative for expression of hormone receptors (< 1% or > 1%) and overexpressing HER2 by immunohistochemistry (IHC) (3+), or, HER2-amplified by fluorescence in situ hybridization (FISH) or by alternative gene testing...
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Neoadjuvant TCHP Versus THP in Patients With HER2-positive Breast Cancer (neoCARHP Study)
Excerpt:...HER2-positive breast cancer scored as 3+ by immunohistochemistry (IHC) in > 10% of immunoreactive cells, or HER2 gene amplification (ratio of HER2 gene signals to centromere 17 signals ≥2.0) by in situ hybridization (ISH)....
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
EC-THP Versus TCbHP in HER2-positive Lymph Node Positive Early Breast Cancer
Excerpt:...- Early breast cancer, pathologically confirmed as HER2 positive; HER2 positive definition: Immunohistochemical HER2 3+ or FISH/CISH test positive (with amplification) is defined as HER2 positive；...
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
A Multicenter, Randomized, Open, Phase III Trial of ddEC-THPvs Evaluating the Efficacy and Safety of TCHP Neoadjuvant Therapy for HER2-positive Breast Cancer
Excerpt:...HER-2 positive breast cancer, defined as immunohistochemical (IHC) detection of 3+ or in situ hybridization (FISH) results of HER2 gene amplification; 4....
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer to Evaluate Treatment With Trastuzumab Plus (+) Pertuzumab + Docetaxel Compared With Trastuzumab + Placebo + Docetaxel
Excerpt:...- HER2-positive breast cancer confirmed by a Sponsor-designated central laboratory and defined as 3+ score by immunohistochemistry in > 10 percent (%) of immunoreactive cells or HER2 gene amplification (ratio of HER2 gene signals to centromere 17 signals equal to or more than [>=] 2.0) by in situ hybridization...
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Neoadjuvant Therapy in Clinical Stage I-III HER2-positive Breast Cancer.
Excerpt:...HER2+, defined by either IHC 3+ or amplification of the HER2 gene by FISH analysis (ratio >2.0 or >6 HER2 targets per cell; patients with equivocal HER2 testing, 2+ by IHC with a FISH ratio of <2.0 and 4-6 HER2 signals per nucleus, are...
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
The Use of FES-PET Imaging as a Tool to Detect a Possible Reversion of Estrogen Receptor (ER)-α Status in Patients With Metastatic Breast Cancer HER2 + and ERα Neg Treated With Trastuzumab + Pertuzumab + Taxane.
Excerpt:...Patient with metastatic breast cancer HER2 + (IHC+++ and/or HER2 amplification in ISH according to ASCO recommendations), ERα neg (0% in IHC) and Progesterone Receptor neg (0% in IHC)....
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Paclitaxel, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer
Excerpt:...- Histologically documented HER2 (+) breast cancer as defined as IHC 3+ or FISH amplification of ≥ 2.0 of primary or metastatic site; results from the local lab are acceptable....
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Markers to Evaluate the Efficacy of PH-based Regimen as a Neoadjuvant Therapy for Operable HER2 Positive Breast Cancer
Excerpt:...HER2-positive disease was defined as follows: disease which overexpresses HER-2 by immunohistochemistry (IHC) 3+ and/or has HER2 amplification according to fluorescence in situ hybridization (FISH)....
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer
Excerpt:...HER2 overexpression or amplification will be based on local test results and is defined as either: (i) IHC staining of 3+ (uniform, intense membrane staining) in greater than or equal to 10% of invasive tumor cells or, (ii) Fluorescent in situ hybridization (FISH) result of more than six HER2 gene copies per nucleus or, (iii) FISH ratio (HER2 gene signals to chromosome 17 signals) of greater than or equal to 2.0....
Less C2 evidence
Evidence Level:Sensitive: C3 – Early Trials
Title:
Predicting Pathological Complete Response in Neoadjuvant Dual Blockade With Trastuzumab and Pertuzumab in HER2 Gene Amplified Breast Cancer
Excerpt:This retrospective study included 159 HER2-amplified patients with locally advanced breast cancer who received neoadjuvant trastuzumab, pertuzumab and chemotherapy....In univariate logistic regression analyses in the training set, the HER2/CEP17 ratio (OR=1.307, p=0.001, 95% CI: 1.117–1.530), HER2 copy number (OR=1.097, p=0.012, 95% CI: 1.021–1.180), and CD8 level (OR=1.072, p=0.024, 95% CI: 1.009–1.139) (Table 2) were better associated with pCR.
DOI:10.3389/fimmu.2022.877825
