GAIN-2: Neo-/adjuvant phase III trial to compare intense dose-dense chemotherapy (CT) to tailored dose-dense CT in patients (pts) with high risk early breast cancer (EBC): Results on safety and interim invasive disease-free survival (iDFS).

Moebus, Volker; Lueck, Hans-Joachim; Ladda, E.; Klare, Peter; Schmidt, Marcus; Schneeweiß, Andreas; Untch, Michael; Marmé, Frederik; Huober, Jens; Stickeler, Elmar; Reinisch, Mattea; Link, Theresa; Sinn, Bruno Valentin; Furlanetto, Jenny; Reimer, Toralf; Solbach, Christine; Schmatloch, Sabine; Rey, Julia; Burchardi, Nicole; Loibl, Sibylle

doi:10.1200/jco.2020.38.15_suppl.516

Cited by 3 publications

(1 citation statement)

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“…Currently, HER2 + BC is defined as the overexpression of HER2 protein as detected by IHC judged as 3+ and/or FISH judged as positive (22,23). In 70-85% of the HER2 − BC, there are still low-to-moderate HER2 expression (IHC 1+/IHC 2+/FISH−) tumors known as HER2 low expression tumors (24). Previous experience of HER2 − BC indicated that it cannot be a target for conventional anti-HER2 therapy.…”

Section: Discussionmentioning

confidence: 99%

Bioinformatics combined with clinical data to analyze clinical characteristics and prognosis in patients with HER2 low expression breast cancer

Chen¹,

Ma²,

Li³

et al. 2023

Gland Surg

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Background: Human epidermal growth factor receptor 2 (HER2) is a landmark protein in determining the targeted treatment of breast cancer (BC). However, the latest research shows that different intensity of HER2 protein expression levels in BC leads to different clinical characteristics, treatment, and prognosis, especially in HER2 low expression patients. Therefore, this study intends to analyze and compare the clinicopathologic features and prognosis of BC patients with low and zero HER2 expression from The Cancer Genome Atlas (TCGA) database and the data collected by our center.Methods: First, the BC dataset was downloaded from TCGA database, including 345 eligible and with complete clinical information BC patients, to compare the difference between HER2 low expression groups and HER2 zero expression groups and their correlation with estrogen receptor (ER) and progesterone receptor (PR) expression. Then, the clinicopathological data and follow-up of 405 patients with HER2 low expression and HER2 zero expression diagnosed with BC admitted to the Affiliated Hospital of Youjiang Medical University for Nationalities (YJMU) from January 2017 to December 2021 were collected to verify the consistency of the results of the two data sets.Results: Both the clinical samples and the TCGA data showed that the ER and PR rates were higher in the HER2 low expression group compared with the HER2 zero expression group. There were no significant differences in tumor size, lymph node metastasis, distant metastasis, and disease-free survival (DFS). In addition, the data analysis of 405 clinical samples also showed that the HER2 low expression group had a lower 3-year recurrence or metastasis rate compared with the HER2 zero expression group.Conclusions: Compared with HER2 zero expression, HER2 low patients express more ER and PR, and have less short-term recurrence and metastasis, but there is no obvious difference in DFS between the two groups.

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Section: Discussionmentioning

confidence: 99%

Bioinformatics combined with clinical data to analyze clinical characteristics and prognosis in patients with HER2 low expression breast cancer

Chen¹,

Ma²,

Li³

et al. 2023

Gland Surg

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Clinical and molecular characteristics of HER2-low-positive breast cancer: pooled analysis of individual patient data from four prospective, neoadjuvant clinical trials

Denkert

Seither

Schneeweiß

et al. 2021

The Lancet Oncology

314

350

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Her2low breast cancer. New opportunities and challenges

2022

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Background. Breast cancer is an increasingly prevalent cancer pathology. In developed countries, breast cancer hits almost every eighth woman and ranks first in the incidence of patients with malignant tumors. The success of breast cancer therapy is apparently connected with the effectiveness of a strategy of impact on typical breast cancer targets, such as estrogen and progesterone receptors, HER2/neu oncoprotein. Implementation of modern achievements of fundamental science into routine clinical practice will allow the prognosis of patients with breast cancer at both earlier and later stages (in cases of the metastatic lesion) to be improved. Purpose. To review modern literature sources that cover biological and clinical relevance of expanding molecular genetic classification of breast cancer for the purpose of singling out additional clinically significant breast cancer subtypes with special emphasis on HER2-low-positive tumors. Materials and methods. The literature search was performed manually by the keywords (breast cancer, HER2-low-positive breast cancer), and also literature sources from evidential databases PubMed, and Web of Science were reviewed. The data from meta-analyses, randomized trials, systematic reviews, cohort trials, and the data of fundamental works were taken into consideration. 41 literature sources were analyzed in total. We opted for the sources which were published over the last ten years. Results. Breast cancer is a heterogeneous disease. Overexpression of the HER2 receptor is peculiar to 15–20% of breast tumors, usually due to amplification of the ERBB2 gene. Taking into account that the ERBB2 gene is a very powerful proto-oncogene, tumors with such phenotype are characterized by aggressive course and unfavorable prognosis. Starting from the 1990s, the development of target drugs aimed at the blockade of HER2 receptors beginning from monoclonal antibodies – trastuzumab, later – pertuzumab, tyrosine kinase inhibitors (lapatinib, neratinib, tucatinib) and the new class of antitumor drugs – conjugates of a monoclonal antibody with a cytostatic drug (trastuzumab emtansine, trastuzumab deruxtecan, trastuzumab duocarmazine) and their implementation into clinical practice changed the course and the prognosis of the patients with HER2-positive breast cancer. In opposition to earlier clinical trials, the results of the more modern ones demonstrate the clinical effectiveness of new antitumor drugs such as conjugates of HER2 monoclonal antibody with a cytostatic drug (trastuzumab deruxtekan, trastuzumab duokarmazine) not only in patients with HER2-positive breast cancer but also in some patients with metastatic breast cancer with low HER2 expression. In order to determine the patients who may potentially benefit from the new target drugs among the patients with HER2-negative breast cancer, a new concept of HER2/neu-low breast cancer has been suggested, which is used for the selection of patients in modern clinical trials, and in the measurable future it will be used in routine clinical practice. Conclusions. Today’s scientific data confirm biological and clinical relevance of expanding molecular genetic classification of breast cancer for the purpose of singling out additional clinically significant breast cancer subtypes with special emphasis on HER2-low-positive tumors. The development of a new class of antitumor drugs, namely conjugates of HER2 monoclonal antibody with a cytostatic drug (trastuzumab deruxtekan, trastuzumab duokarmazine) gives new therapeutic possibilities for patients with breast cancer, and also for patients with other types of malignant tumors.

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GAIN-2: Neo-/adjuvant phase III trial to compare intense dose-dense chemotherapy (CT) to tailored dose-dense CT in patients (pts) with high risk early breast cancer (EBC): Results on safety and interim invasive disease-free survival (iDFS).

Cited by 3 publications

References 0 publications

Bioinformatics combined with clinical data to analyze clinical characteristics and prognosis in patients with HER2 low expression breast cancer

Bioinformatics combined with clinical data to analyze clinical characteristics and prognosis in patients with HER2 low expression breast cancer

Clinical and molecular characteristics of HER2-low-positive breast cancer: pooled analysis of individual patient data from four prospective, neoadjuvant clinical trials

Her2low breast cancer. New opportunities and challenges

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